<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04495166</url>
  </required_header>
  <id_info>
    <org_study_id>Motherly1</org_study_id>
    <secondary_id>SB-POC-1810-20573</secondary_id>
    <nct_id>NCT04495166</nct_id>
  </id_info>
  <brief_title>A Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression</brief_title>
  <official_title>Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Grand Challenges Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fundação Maria Cecilia Souto Vidigal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators developed Motherly 1.0, a smartphone app designed to treat and promote maternal&#xD;
      mental health. A 2-arm parallel-randomized controlled clinical trial (RCT) will be conducted&#xD;
      to test the efficacy of Motherly in conjunction with brief cognitive-behavioral therapy. 70&#xD;
      pregnant women between 16-40 years old will be recruited. Since all interventions will be&#xD;
      conducted online, participants will be recruited from any Brazilian state or municipality.&#xD;
      Participants will be randomly assigned to either receive intervention via app consisting of&#xD;
      behavioral activation and psychoeducation to promote changes in sleep, nutrition, and&#xD;
      physical activity habits, as well as to engage in prenatal care, breastfeeding, and social&#xD;
      support, and to stimulate child development, in addition to brief cognitive-behavioral&#xD;
      therapy (CBT) (n=35); or to a comparison group receiving an psychoeducational app (active&#xD;
      control) with psychoeducational content about gestation, maternal health and mental health,&#xD;
      and child development in addition to brief CBT (n=35). Duration of treatment will be eight&#xD;
      weeks, during which participants in both groups will be assessed at the beginning (baseline;&#xD;
      T0), weeks 3-4 (midpoint; T1), and week 8 (endpoint; T2) in order to evaluate treatment&#xD;
      effects. A follow-up postnatal assessment will also be conducted when the child is three&#xD;
      months of age (T3).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Actual">April 27, 2021</completion_date>
  <primary_completion_date type="Actual">November 23, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks)</measure>
    <time_frame>Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).</time_frame>
    <description>Participants were assessed with the Edinburgh Postnatal Depression Scale (EPDS) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (EPDS max-min scores=0-30, higher scores=worse outcome).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Maternal Prenatal Anxiety From Baseline to Posttreatment (8 Weeks)</measure>
    <time_frame>Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).</time_frame>
    <description>Participants will be assessed with the Generalized Anxiety Disorder 7 (GAD-7) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (GAD-7 max-min scores=0-21, higher scores=worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maternal Prenatal Quality of Life From Baseline to Posttreatment (8 Weeks)</measure>
    <time_frame>Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).</time_frame>
    <description>Participants will be assessed with the 12-item health survey (SF-12) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (SF-12 max-min scores=12-50, higher scores=worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maternal Prenatal Psychological Well-Being From Baseline to Posttreatment (8 Weeks).</measure>
    <time_frame>Baseline (T0), Week 8 (Posttreatment, T2).</time_frame>
    <description>Participants were assessed with the Ryff's Psychological Well-Being Scale at baseline and at 8 weeks (posttreatment). (Ryff's Psychological Well-Being Scale max-min Total scores=36-216; higher scores=better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maternal Physical Activity Levels From Baseline to Posttreatment (8 Weeks).</measure>
    <time_frame>Baseline (T0), Week 8 (Posttreatment, T2).</time_frame>
    <description>Participants were assessed with the International Physical Activity Questionnaire (IPAQ) at baseline and at 8 weeks (posttreatment). (IPAQ measures Total Metabolic Equivalent of Task (MET) minutes per week (MET-min per week), higher MET-min per week=better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maternal Prenatal Perceived Stress From Baseline to Posttreatment (8 Weeks).</measure>
    <time_frame>Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).</time_frame>
    <description>Participants were assessed with the Perceived Stress Scale (PSS) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (PSS max-min scores=0-40, higher scores=worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maternal Prenatal Depression Severity From Baseline to Posttreatment (8 Weeks).</measure>
    <time_frame>Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).</time_frame>
    <description>Participants were assessed with the Clinical Global Impressions Scale-Improvement (CGI-I). (scores in this scale are: 1=very much improved, 2= much improved, 3= minimally improved, 4 = no change, 5 = minimally worse, 6= much worse, 7= very much worse; scores were recoded as binary variable: improved (1, 2, 3) vs not-improved (4, 5, 6, 7).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maternal Prenatal Sleep Quality From Baseline to Posttreatment (8 Weeks).</measure>
    <time_frame>Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).</time_frame>
    <description>Participants were assessed with the Single-item Sleep Quality Scale (SIMP) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (SIMP max-min scores=0-10, higher scores=better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant Developmental Milestones at 2 Months of Age.</measure>
    <time_frame>When the infant is two months of age (Follow-up, T3).</time_frame>
    <description>Child developmental milestones will be assessed with the Survey of Well-being of Young Children (SWYC) at 2 months of the child's age. (SWYC min-max=0-20, higher scores=better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant Social/Emotional Problems at 2 Months of Age.</measure>
    <time_frame>When the infant is two months of age (Follow-up, T3).</time_frame>
    <description>Infants will be assessed with the Baby Pediatric Symptom Checklist (BPSC) at 2 months of the child's age. (BPSC min-max=0-24, higher scores=worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maternal Prenatal Depression From Baseline to Follow-up.</measure>
    <time_frame>Baseline (T0), when the infant is two months of age (Follow-up, T3).</time_frame>
    <description>Participants will be assessed with the Edinburgh Postnatal Depression Scale (EPDS) at baseline and when the infant is two months of age (Follow-up, T3). (EPDS max-min scores=0-30, higher scores=worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maternal Prenatal Anxiety From Baseline to to Follow-up.</measure>
    <time_frame>Baseline (T0), when the infant is two months of age (Follow-up, T3).</time_frame>
    <description>Participants will be assessed with the Generalized Anxiety Disorder 7 (GAD-7) at baseline and when the infant is two months of age (Follow-up, T3). (GAD-7 max-min scores=0-21, higher scores=worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maternal Prenatal Quality of Life From Baseline to to Follow-up.</measure>
    <time_frame>Baseline (T0), when the infant is two months of age (Follow-up, T3).</time_frame>
    <description>Participants will be assessed with the 12-item health survey (SF-12) at baseline and when the infant is two months of age (Follow-up, T3). (SF-12 max-min scores=12-50, higher scores=worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maternal Prenatal Psychological Well-Being From Baseline to Follow-up.</measure>
    <time_frame>Baseline (T0), when the infant is two months of age (Follow-up, T3).</time_frame>
    <description>Participants will be assessed with the Ryff's Psychological Well-Being Scale at baseline and when the infant is two months of age (Follow-up, T3). (Ryff's Psychological Well-Being Scale max-min scores=6-36, higher scores=better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maternal Prenatal Perceived Stress From Baseline to Follow-up.</measure>
    <time_frame>Baseline (T0), when the infant is two months of age (Follow-up, T3).</time_frame>
    <description>Participants will be assessed with the Perceived Stress Scale (PSS) at baseline and when the infant is two months of age (Follow-up, T3). (PSS max-min scores=0-40, higher scores=worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maternal Prenatal Depression Severity From Baseline to Follow-up.</measure>
    <time_frame>Baseline (T0), when the infant is two months of age (Follow-up, T3).</time_frame>
    <description>Participants will be assessed with the Clinical Global Impressions Scale-Improvement (CGI-I) when the infant is two months of age (Follow-up, T3). (CGI-I, min-max=0-7, higher scores=worst outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maternal Prenatal Sleep Quality From Baseline to Follow-up.</measure>
    <time_frame>Baseline (T0), when the infant is two months of age (Follow-up, T3).</time_frame>
    <description>Participants will be assessed with the Single-item Sleep Quality Scale (SIMP) at baseline and when the infant is two months of age (Follow-up, T3). (SIMP max-min scores=0-10, higher scores=better outcome).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Perinatal Depression</condition>
  <arm_group>
    <arm_group_label>Motherly app with brief psychotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition will undergo brief Cognitive-Behavioral Therapy (CBT) with a focus on behavioral activation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Educational app (Active control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm will have access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they will undergo will undergo brief Cognitive-Behavioral Therapy (CBT) with a focus on behavioral activation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motherly 1.0</intervention_name>
    <description>A mobile app designed to promote life habits that have been shown to improve physical and mental health in pregnant women. The app consists of a package of specific and customized interventions defined by eight different modules: 1) Mental Health; 2) Sleep; 3) Nutrition; 4) Physical activity; 5) Social support; 6) Prenatal support; 7) Postnatal support, and 8) Library of pre and postnatal content. The app relies on extensive psychoeducational content delivered as tutorials, brief messages, and available as a library that can be read at the users' discretion; behavior monitoring using schedules, checklists, and notifications to help participants keep track of their health care visits, and schedule behavior activation activities; and gaming elements such as changes in background appearance to reflect participant's mood assessment and ratings of activities, and graphical and easy-to-use questionnaires for obtaining information (mood, nutrition habits).</description>
    <arm_group_label>Motherly app with brief psychotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Psychotherapy</intervention_name>
    <description>Brief Cognitive-Behavioral Therapy (CBT) with a focus on behavioral activation (BA). Participants will be guided by psychotherapists to plan, schedule, and engage in positively reinforcing activities, and will be aided to develop problem-solving strategies for circumventing barriers to completing scheduled activities. Implementation of these techniques will be conducted with the aid of the Motherly 1.0 for participants in the experimental arm; for participants in the control arm, BA will be implemented without the aid of Motherly 1.0. Throughout the four sessions, psychotherapists will monitor participants' adherence, answering questions about the strategies and providing support for solving problems or CBT techniques, such as cognitive restructuring, relaxation techniques, sleep hygiene, stress and anxiety management, among other evidence-based techniques might be used if appropriate to the case.</description>
    <arm_group_label>Educational app (Active control)</arm_group_label>
    <arm_group_label>Motherly app with brief psychotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational app</intervention_name>
    <description>A simplified version of the Motherly 1.0 app consisting of psychoeducational content about various aspects of pregnancy, maternal physical and mental health, and child development. Active intervention functionalities, such as behavioral activation, activity scheduling, sleep hygiene, among others, are NOT present in this simplified version of the app.</description>
    <arm_group_label>Educational app (Active control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women aged between 16-40 years;&#xD;
&#xD;
          -  having a score of &gt;7 on the Edinburgh Postnatal Depression Scale (EPDS);&#xD;
&#xD;
          -  gestational age between 17-26 weeks;&#xD;
&#xD;
          -  being literate;&#xD;
&#xD;
          -  owning a functional smartphone with Android for personal use.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancies classified as being at risk, fetal malformation, or congenital disease;&#xD;
&#xD;
          -  visual, auditory or intellectual disabilities, or chronic diseases associated with&#xD;
             fetal development alterations;&#xD;
&#xD;
          -  severe and/or chronic mental disorder (e.g., schizophrenia, bipolar disorder, etc).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Fatori, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical School, University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Daniel Fatori</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Sockol LE, Epperson CN, Barber JP. A meta-analysis of treatments for perinatal depression. Clin Psychol Rev. 2011 Jul;31(5):839-49. doi: 10.1016/j.cpr.2011.03.009. Epub 2011 Mar 27.</citation>
    <PMID>21545782</PMID>
  </reference>
  <reference>
    <citation>Graham JW, Olchowski AE, Gilreath TD. How many imputations are really needed? Some practical clarifications of multiple imputation theory. Prev Sci. 2007 Sep;8(3):206-13. doi: 10.1007/s11121-007-0070-9. Epub 2007 Jun 5.</citation>
    <PMID>17549635</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <results_first_submitted>September 29, 2021</results_first_submitted>
  <results_first_submitted_qc>November 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 11, 2022</results_first_posted>
  <last_update_submitted>November 10, 2021</last_update_submitted>
  <last_update_submitted_qc>November 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Guilherme Vanoni Polanczyk, MD PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 31, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT04495166/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited via social media advertisements from August to September 2020. After demonstrating interest in the study, potential participants were referred to a website page where they were informed of the study's aims, procedures, assessments, and nature of the interventions. They responded to an online survey assessing eligibility criteria. Eligible participants were invited to a baseline assessment conducted via internet or telephone.</recruitment_details>
      <pre_assignment_details>Three hundred and twenty (320) women registered online, but 188 did not meet eligibility criteria and one had a duplicated registration. Thirty-six (36) women were excluded in a brief telephone because they did not meet eligibility criteria or declined to participate in the study. Ninety-five (95) women were scheduled for baseline assessment, but 14 cancelled or missed the appointment. Eighty one (81) participants were enrolled and randomized to intervention (N=37) or active control (N=44).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Motherly App With Brief Psychotherapy</title>
          <description>Participants in this arm received intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
        </group>
        <group group_id="P2">
          <title>Educational App (Active Control)</title>
          <description>Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Motherly App With Brief Psychotherapy</title>
          <description>Participants in this arm received intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
        </group>
        <group group_id="B2">
          <title>Educational App (Active Control)</title>
          <description>Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="37"/>
            <count group_id="B2" value="44"/>
            <count group_id="B3" value="81"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.8" spread="4.6"/>
                    <measurement group_id="B2" value="32.3" spread="4.9"/>
                    <measurement group_id="B3" value="32.5" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-white</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of people in the house</title>
          <units>people in the house</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.0" spread="1.2"/>
                    <measurement group_id="B2" value="2.8" spread="1.2"/>
                    <measurement group_id="B3" value="2.9" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participant has college degree or higher</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participant is working for pay</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Family income in Brazilian Real</title>
          <units>Brazilian Reais (R$)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5108.8" spread="4434.7"/>
                    <measurement group_id="B2" value="4214.8" spread="3179.3"/>
                    <measurement group_id="B3" value="4623.1" spread="3805.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participant is studying</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participant is married or in a stable relationship</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of prenatal visits</title>
          <units>prenatal visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.8" spread="1.6"/>
                    <measurement group_id="B2" value="4.6" spread="1.8"/>
                    <measurement group_id="B3" value="4.3" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gestational age in weeks</title>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.7" spread="2.8"/>
                    <measurement group_id="B2" value="19.9" spread="3.3"/>
                    <measurement group_id="B3" value="19.4" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participant diagnosed with high-risk pregnancy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participant is receiving mental health treatment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participant used alcohol during gestation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participant used tobacco during gestation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participant used cannabis during gestation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks)</title>
        <description>Participants were assessed with the Edinburgh Postnatal Depression Scale (EPDS) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (EPDS max-min scores=0-30, higher scores=worse outcome).</description>
        <time_frame>Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).</time_frame>
        <population>In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.</population>
        <group_list>
          <group group_id="O1">
            <title>Motherly App With Brief Psychotherapy</title>
            <description>Participants in this arm received intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
          </group>
          <group group_id="O2">
            <title>Educational App (Active Control)</title>
            <description>Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks)</title>
          <description>Participants were assessed with the Edinburgh Postnatal Depression Scale (EPDS) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (EPDS max-min scores=0-30, higher scores=worse outcome).</description>
          <population>In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.</population>
          <units>score on EPDS</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3" lower_limit="15.8" upper_limit="18.8"/>
                    <measurement group_id="O2" value="16.8" lower_limit="15.5" upper_limit="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" lower_limit="10.8" upper_limit="14.2"/>
                    <measurement group_id="O2" value="12.1" lower_limit="10.5" upper_limit="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1" lower_limit="9.3" upper_limit="13.0"/>
                    <measurement group_id="O2" value="10.8" lower_limit="9.1" upper_limit="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The sample size was calculated based on an effect size of 0.65 on depression, which is based on a previous meta-analysis (Sockol et al., 2011). Sample size calculation considered a difference in means between two independent groups, probability of type I error of 5%, statistical power of 80%, a two-tailed test, and a dropout rate of 15%.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.757</p_value>
            <p_value_desc>Statistical tests were 2-sided and p values &lt;0.05 were considered statistically significant</p_value_desc>
            <method>t-test, 2 sided</method>
            <method_desc>To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maternal Prenatal Anxiety From Baseline to Posttreatment (8 Weeks)</title>
        <description>Participants will be assessed with the Generalized Anxiety Disorder 7 (GAD-7) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (GAD-7 max-min scores=0-21, higher scores=worse outcome).</description>
        <time_frame>Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).</time_frame>
        <population>In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.</population>
        <group_list>
          <group group_id="O1">
            <title>Motherly App With Brief Psychotherapy</title>
            <description>Participants in this arm received intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
          </group>
          <group group_id="O2">
            <title>Educational App (Active Control)</title>
            <description>Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maternal Prenatal Anxiety From Baseline to Posttreatment (8 Weeks)</title>
          <description>Participants will be assessed with the Generalized Anxiety Disorder 7 (GAD-7) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (GAD-7 max-min scores=0-21, higher scores=worse outcome).</description>
          <population>In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.</population>
          <units>Score on the GAD-7</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" lower_limit="12.8" upper_limit="15.3"/>
                    <measurement group_id="O2" value="13.5" lower_limit="11.9" upper_limit="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1" lower_limit="9.4" upper_limit="12.8"/>
                    <measurement group_id="O2" value="10.9" lower_limit="9.3" upper_limit="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" lower_limit="7.8" upper_limit="11.8"/>
                    <measurement group_id="O2" value="9.7" lower_limit="7.9" upper_limit="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.910</p_value>
            <p_value_desc>Statistical tests were 2-sided and p values &lt;0.05 were considered statistically significant</p_value_desc>
            <method>t-test, 2 sided</method>
            <method_desc>To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maternal Prenatal Quality of Life From Baseline to Posttreatment (8 Weeks)</title>
        <description>Participants will be assessed with the 12-item health survey (SF-12) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (SF-12 max-min scores=12-50, higher scores=worse outcome).</description>
        <time_frame>Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).</time_frame>
        <population>This measure was not collected during all RCT due to logistics and the need to reduce data collection time.</population>
        <group_list>
          <group group_id="O1">
            <title>Motherly App With Brief Psychotherapy</title>
            <description>Participants in this arm received intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
          </group>
          <group group_id="O2">
            <title>Educational App (Active Control)</title>
            <description>Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maternal Prenatal Quality of Life From Baseline to Posttreatment (8 Weeks)</title>
          <description>Participants will be assessed with the 12-item health survey (SF-12) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (SF-12 max-min scores=12-50, higher scores=worse outcome).</description>
          <population>This measure was not collected during all RCT due to logistics and the need to reduce data collection time.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maternal Prenatal Psychological Well-Being From Baseline to Posttreatment (8 Weeks).</title>
        <description>Participants were assessed with the Ryff's Psychological Well-Being Scale at baseline and at 8 weeks (posttreatment). (Ryff's Psychological Well-Being Scale max-min Total scores=36-216; higher scores=better outcome).</description>
        <time_frame>Baseline (T0), Week 8 (Posttreatment, T2).</time_frame>
        <population>In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.</population>
        <group_list>
          <group group_id="O1">
            <title>Motherly App With Brief Psychotherapy</title>
            <description>Participants in this arm received intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
          </group>
          <group group_id="O2">
            <title>Educational App (Active Control)</title>
            <description>Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maternal Prenatal Psychological Well-Being From Baseline to Posttreatment (8 Weeks).</title>
          <description>Participants were assessed with the Ryff's Psychological Well-Being Scale at baseline and at 8 weeks (posttreatment). (Ryff's Psychological Well-Being Scale max-min Total scores=36-216; higher scores=better outcome).</description>
          <population>In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.</population>
          <units>Score on the PWB</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149.7" lower_limit="142.6" upper_limit="156.7"/>
                    <measurement group_id="O2" value="140.4" lower_limit="133.1" upper_limit="147.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157.6" lower_limit="149.7" upper_limit="165.4"/>
                    <measurement group_id="O2" value="153.0" lower_limit="144.6" upper_limit="161.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.442</p_value>
            <p_value_desc>Statistical tests were 2-sided and p values &lt;0.05 were considered statistically significant</p_value_desc>
            <method>t-test, 2 sided</method>
            <method_desc>To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maternal Physical Activity Levels From Baseline to Posttreatment (8 Weeks).</title>
        <description>Participants were assessed with the International Physical Activity Questionnaire (IPAQ) at baseline and at 8 weeks (posttreatment). (IPAQ measures Total Metabolic Equivalent of Task (MET) minutes per week (MET-min per week), higher MET-min per week=better outcome).</description>
        <time_frame>Baseline (T0), Week 8 (Posttreatment, T2).</time_frame>
        <population>In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.</population>
        <group_list>
          <group group_id="O1">
            <title>Motherly App With Brief Psychotherapy</title>
            <description>Participants in this arm received intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
          </group>
          <group group_id="O2">
            <title>Educational App (Active Control)</title>
            <description>Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maternal Physical Activity Levels From Baseline to Posttreatment (8 Weeks).</title>
          <description>Participants were assessed with the International Physical Activity Questionnaire (IPAQ) at baseline and at 8 weeks (posttreatment). (IPAQ measures Total Metabolic Equivalent of Task (MET) minutes per week (MET-min per week), higher MET-min per week=better outcome).</description>
          <population>In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.</population>
          <units>MET-min per week</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1626.0" lower_limit="845.1" upper_limit="2407.0"/>
                    <measurement group_id="O2" value="2160.1" lower_limit="1355.4" upper_limit="2964.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2770.0" lower_limit="682.4" upper_limit="4859.0"/>
                    <measurement group_id="O2" value="1540.1" lower_limit="1040.7" upper_limit="2039.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.223</p_value>
            <p_value_desc>Statistical tests were 2-sided and p values &lt;0.05 were considered statistically significant</p_value_desc>
            <method>t-test, 2 sided</method>
            <method_desc>To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maternal Prenatal Perceived Stress From Baseline to Posttreatment (8 Weeks).</title>
        <description>Participants were assessed with the Perceived Stress Scale (PSS) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (PSS max-min scores=0-40, higher scores=worse outcome).</description>
        <time_frame>Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).</time_frame>
        <population>In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.</population>
        <group_list>
          <group group_id="O1">
            <title>Motherly App With Brief Psychotherapy</title>
            <description>Participants in this arm received intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
          </group>
          <group group_id="O2">
            <title>Educational App (Active Control)</title>
            <description>Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maternal Prenatal Perceived Stress From Baseline to Posttreatment (8 Weeks).</title>
          <description>Participants were assessed with the Perceived Stress Scale (PSS) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (PSS max-min scores=0-40, higher scores=worse outcome).</description>
          <population>In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.</population>
          <units>Score on the PSS</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.5" lower_limit="24.7" upper_limit="28.3"/>
                    <measurement group_id="O2" value="26.6" lower_limit="24.6" upper_limit="28.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.6" lower_limit="23.5" upper_limit="27.7"/>
                    <measurement group_id="O2" value="25.0" lower_limit="22.9" upper_limit="27.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.9" lower_limit="21.5" upper_limit="26.4"/>
                    <measurement group_id="O2" value="22.9" lower_limit="20.6" upper_limit="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.540</p_value>
            <p_value_desc>Statistical tests were 2-sided and p values &lt;0.05 were considered statistically significant</p_value_desc>
            <method>t-test, 2 sided</method>
            <method_desc>To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maternal Prenatal Depression Severity From Baseline to Posttreatment (8 Weeks).</title>
        <description>Participants were assessed with the Clinical Global Impressions Scale-Improvement (CGI-I). (scores in this scale are: 1=very much improved, 2= much improved, 3= minimally improved, 4 = no change, 5 = minimally worse, 6= much worse, 7= very much worse; scores were recoded as binary variable: improved (1, 2, 3) vs not-improved (4, 5, 6, 7).</description>
        <time_frame>Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).</time_frame>
        <population>In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.</population>
        <group_list>
          <group group_id="O1">
            <title>Motherly App With Brief Psychotherapy</title>
            <description>Participants in this arm received intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
          </group>
          <group group_id="O2">
            <title>Educational App (Active Control)</title>
            <description>Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maternal Prenatal Depression Severity From Baseline to Posttreatment (8 Weeks).</title>
          <description>Participants were assessed with the Clinical Global Impressions Scale-Improvement (CGI-I). (scores in this scale are: 1=very much improved, 2= much improved, 3= minimally improved, 4 = no change, 5 = minimally worse, 6= much worse, 7= very much worse; scores were recoded as binary variable: improved (1, 2, 3) vs not-improved (4, 5, 6, 7).</description>
          <population>In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.</population>
          <units>Proportion (in percentage)</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63" lower_limit="45" upper_limit="80"/>
                    <measurement group_id="O2" value="73" lower_limit="59" upper_limit="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80" lower_limit="65" upper_limit="94"/>
                    <measurement group_id="O2" value="80" lower_limit="66" upper_limit="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.901</p_value>
            <p_value_desc>Statistical tests were 2-sided and p values &lt;0.05 were considered statistically significant</p_value_desc>
            <method>t-test, 2 sided</method>
            <method_desc>To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maternal Prenatal Sleep Quality From Baseline to Posttreatment (8 Weeks).</title>
        <description>Participants were assessed with the Single-item Sleep Quality Scale (SIMP) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (SIMP max-min scores=0-10, higher scores=better outcome).</description>
        <time_frame>Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).</time_frame>
        <population>In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.</population>
        <group_list>
          <group group_id="O1">
            <title>Motherly App With Brief Psychotherapy</title>
            <description>Participants in this arm received intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
          </group>
          <group group_id="O2">
            <title>Educational App (Active Control)</title>
            <description>Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maternal Prenatal Sleep Quality From Baseline to Posttreatment (8 Weeks).</title>
          <description>Participants were assessed with the Single-item Sleep Quality Scale (SIMP) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (SIMP max-min scores=0-10, higher scores=better outcome).</description>
          <population>In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.</population>
          <units>Score on SQA</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" lower_limit="4.0" upper_limit="5.2"/>
                    <measurement group_id="O2" value="4.6" lower_limit="4.0" upper_limit="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" lower_limit="4.8" upper_limit="6.4"/>
                    <measurement group_id="O2" value="5.0" lower_limit="4.3" upper_limit="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" lower_limit="4.7" upper_limit="6.5"/>
                    <measurement group_id="O2" value="5.4" lower_limit="4.7" upper_limit="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.748</p_value>
            <p_value_desc>Statistical tests were 2-sided and p values &lt;0.05 were considered statistically significant</p_value_desc>
            <method>t-test, 2 sided</method>
            <method_desc>To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Infant Developmental Milestones at 2 Months of Age.</title>
        <description>Child developmental milestones will be assessed with the Survey of Well-being of Young Children (SWYC) at 2 months of the child's age. (SWYC min-max=0-20, higher scores=better outcome).</description>
        <time_frame>When the infant is two months of age (Follow-up, T3).</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Infant Social/Emotional Problems at 2 Months of Age.</title>
        <description>Infants will be assessed with the Baby Pediatric Symptom Checklist (BPSC) at 2 months of the child's age. (BPSC min-max=0-24, higher scores=worse outcome).</description>
        <time_frame>When the infant is two months of age (Follow-up, T3).</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maternal Prenatal Depression From Baseline to Follow-up.</title>
        <description>Participants will be assessed with the Edinburgh Postnatal Depression Scale (EPDS) at baseline and when the infant is two months of age (Follow-up, T3). (EPDS max-min scores=0-30, higher scores=worse outcome).</description>
        <time_frame>Baseline (T0), when the infant is two months of age (Follow-up, T3).</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maternal Prenatal Anxiety From Baseline to to Follow-up.</title>
        <description>Participants will be assessed with the Generalized Anxiety Disorder 7 (GAD-7) at baseline and when the infant is two months of age (Follow-up, T3). (GAD-7 max-min scores=0-21, higher scores=worse outcome).</description>
        <time_frame>Baseline (T0), when the infant is two months of age (Follow-up, T3).</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maternal Prenatal Quality of Life From Baseline to to Follow-up.</title>
        <description>Participants will be assessed with the 12-item health survey (SF-12) at baseline and when the infant is two months of age (Follow-up, T3). (SF-12 max-min scores=12-50, higher scores=worse outcome).</description>
        <time_frame>Baseline (T0), when the infant is two months of age (Follow-up, T3).</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maternal Prenatal Psychological Well-Being From Baseline to Follow-up.</title>
        <description>Participants will be assessed with the Ryff's Psychological Well-Being Scale at baseline and when the infant is two months of age (Follow-up, T3). (Ryff's Psychological Well-Being Scale max-min scores=6-36, higher scores=better outcome).</description>
        <time_frame>Baseline (T0), when the infant is two months of age (Follow-up, T3).</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maternal Prenatal Perceived Stress From Baseline to Follow-up.</title>
        <description>Participants will be assessed with the Perceived Stress Scale (PSS) at baseline and when the infant is two months of age (Follow-up, T3). (PSS max-min scores=0-40, higher scores=worse outcome).</description>
        <time_frame>Baseline (T0), when the infant is two months of age (Follow-up, T3).</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maternal Prenatal Depression Severity From Baseline to Follow-up.</title>
        <description>Participants will be assessed with the Clinical Global Impressions Scale-Improvement (CGI-I) when the infant is two months of age (Follow-up, T3). (CGI-I, min-max=0-7, higher scores=worst outcome).</description>
        <time_frame>Baseline (T0), when the infant is two months of age (Follow-up, T3).</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maternal Prenatal Sleep Quality From Baseline to Follow-up.</title>
        <description>Participants will be assessed with the Single-item Sleep Quality Scale (SIMP) at baseline and when the infant is two months of age (Follow-up, T3). (SIMP max-min scores=0-10, higher scores=better outcome).</description>
        <time_frame>Baseline (T0), when the infant is two months of age (Follow-up, T3).</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected throughout the trial by psychotherapist during their sessions with participants. Moreover, assessors collected information on adverse events during the assessments at baseline (T0), mid-treatment (T1), posttreatment (T3).</time_frame>
      <desc>Given that the intervention in this study is non-invasive, with a very low risk for participants of serious adverse events and mortality, then adverse events were collected qualitatively throughout the trial by the assessors, who asked participants about psychological distress and discomfort from the interventions.</desc>
      <group_list>
        <group group_id="E1">
          <title>Motherly App With Brief Psychotherapy</title>
          <description>Participants in this arm received intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
        </group>
        <group group_id="E2">
          <title>Educational App (Active Control)</title>
          <description>Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>sample was primarily composed of highly educated women with high family income. Therefore, considering Brazil is a LMIC with inequality and widespread poverty, it is difficult to generalize our findings to other regions and countries. Study was conducted during the COVID-19 pandemic, which may have impacted participants' mental health.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Daniel Fatori</name_or_title>
      <organization>Medical School of the University of Sao Paulo</organization>
      <phone>5511 96162-6183</phone>
      <email>daniel.fatori@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04495166
org study id: Motherly1
secondary id: SB-POC-1810-20573
nct id: NCT04495166
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Investigators developed Motherly 1.0, a smartphone app designed to treat and promote maternal
      mental health. A 2-arm parallel-randomized controlled clinical trial (RCT) will be conducted
      to test the efficacy of Motherly in conjunction with brief cognitive-behavioral therapy. 70
      pregnant women between 16-40 years old will be recruited. Since all interventions will be
      conducted online, participants will be recruited from any Brazilian state or municipality.
      Participants will be randomly assigned to either receive intervention via app consisting of
      behavioral activation and psychoeducation to promote changes in sleep, nutrition, and
      physical activity habits, as well as to engage in prenatal care, breastfeeding, and social
      support, and to stimulate child development, in addition to brief cognitive-behavioral
      therapy (CBT) (n=35); or to a comparison group receiving an psychoeducational app (active
      control) with psychoeducational content about gestation, maternal health and mental health,
      and child development in addition to brief CBT (n=35). Duration of treatment will be eight
      weeks, during which participants in both groups will be assessed at the beginning (baseline;
      T0), weeks 3-4 (midpoint; T1), and week 8 (endpoint; T2) in order to evaluate treatment
      effects. A follow-up postnatal assessment will also be conducted when the child is three
      months of age (T3).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks)
time frame: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
description: Participants were assessed with the Edinburgh Postnatal Depression Scale (EPDS) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (EPDS max-min scores=0-30, higher scores=worse outcome).
measure: Change in Maternal Prenatal Anxiety From Baseline to Posttreatment (8 Weeks)
time frame: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
description: Participants will be assessed with the Generalized Anxiety Disorder 7 (GAD-7) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (GAD-7 max-min scores=0-21, higher scores=worse outcome).
measure: Change in Maternal Prenatal Quality of Life From Baseline to Posttreatment (8 Weeks)
time frame: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
description: Participants will be assessed with the 12-item health survey (SF-12) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (SF-12 max-min scores=12-50, higher scores=worse outcome).
measure: Change in Maternal Prenatal Psychological Well-Being From Baseline to Posttreatment (8 Weeks).
time frame: Baseline (T0), Week 8 (Posttreatment, T2).
description: Participants were assessed with the Ryff's Psychological Well-Being Scale at baseline and at 8 weeks (posttreatment). (Ryff's Psychological Well-Being Scale max-min Total scores=36-216; higher scores=better outcome).
measure: Change in Maternal Physical Activity Levels From Baseline to Posttreatment (8 Weeks).
time frame: Baseline (T0), Week 8 (Posttreatment, T2).
description: Participants were assessed with the International Physical Activity Questionnaire (IPAQ) at baseline and at 8 weeks (posttreatment). (IPAQ measures Total Metabolic Equivalent of Task (MET) minutes per week (MET-min per week), higher MET-min per week=better outcome).
measure: Change in Maternal Prenatal Perceived Stress From Baseline to Posttreatment (8 Weeks).
time frame: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
description: Participants were assessed with the Perceived Stress Scale (PSS) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (PSS max-min scores=0-40, higher scores=worse outcome).
measure: Change in Maternal Prenatal Depression Severity From Baseline to Posttreatment (8 Weeks).
time frame: Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
description: Participants were assessed with the Clinical Global Impressions Scale-Improvement (CGI-I). (scores in this scale are: 1=very much improved, 2= much improved, 3= minimally improved, 4 = no change, 5 = minimally worse, 6= much worse, 7= very much worse; scores were recoded as binary variable: improved (1, 2, 3) vs not-improved (4, 5, 6, 7).
measure: Change in Maternal Prenatal Sleep Quality From Baseline to Posttreatment (8 Weeks).
time frame: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
description: Participants were assessed with the Single-item Sleep Quality Scale (SIMP) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (SIMP max-min scores=0-10, higher scores=better outcome).
measure: Infant Developmental Milestones at 2 Months of Age.
time frame: When the infant is two months of age (Follow-up, T3).
description: Child developmental milestones will be assessed with the Survey of Well-being of Young Children (SWYC) at 2 months of the child's age. (SWYC min-max=0-20, higher scores=better outcome).
measure: Infant Social/Emotional Problems at 2 Months of Age.
time frame: When the infant is two months of age (Follow-up, T3).
description: Infants will be assessed with the Baby Pediatric Symptom Checklist (BPSC) at 2 months of the child's age. (BPSC min-max=0-24, higher scores=worse outcome).
measure: Change in Maternal Prenatal Depression From Baseline to Follow-up.
time frame: Baseline (T0), when the infant is two months of age (Follow-up, T3).
description: Participants will be assessed with the Edinburgh Postnatal Depression Scale (EPDS) at baseline and when the infant is two months of age (Follow-up, T3). (EPDS max-min scores=0-30, higher scores=worse outcome).
measure: Change in Maternal Prenatal Anxiety From Baseline to to Follow-up.
time frame: Baseline (T0), when the infant is two months of age (Follow-up, T3).
description: Participants will be assessed with the Generalized Anxiety Disorder 7 (GAD-7) at baseline and when the infant is two months of age (Follow-up, T3). (GAD-7 max-min scores=0-21, higher scores=worse outcome).
measure: Change in Maternal Prenatal Quality of Life From Baseline to to Follow-up.
time frame: Baseline (T0), when the infant is two months of age (Follow-up, T3).
description: Participants will be assessed with the 12-item health survey (SF-12) at baseline and when the infant is two months of age (Follow-up, T3). (SF-12 max-min scores=12-50, higher scores=worse outcome).
measure: Change in Maternal Prenatal Psychological Well-Being From Baseline to Follow-up.
time frame: Baseline (T0), when the infant is two months of age (Follow-up, T3).
description: Participants will be assessed with the Ryff's Psychological Well-Being Scale at baseline and when the infant is two months of age (Follow-up, T3). (Ryff's Psychological Well-Being Scale max-min scores=6-36, higher scores=better outcome).
measure: Change in Maternal Prenatal Perceived Stress From Baseline to Follow-up.
time frame: Baseline (T0), when the infant is two months of age (Follow-up, T3).
description: Participants will be assessed with the Perceived Stress Scale (PSS) at baseline and when the infant is two months of age (Follow-up, T3). (PSS max-min scores=0-40, higher scores=worse outcome).
measure: Change in Maternal Prenatal Depression Severity From Baseline to Follow-up.
time frame: Baseline (T0), when the infant is two months of age (Follow-up, T3).
description: Participants will be assessed with the Clinical Global Impressions Scale-Improvement (CGI-I) when the infant is two months of age (Follow-up, T3). (CGI-I, min-max=0-7, higher scores=worst outcome).
measure: Change in Maternal Prenatal Sleep Quality From Baseline to Follow-up.
time frame: Baseline (T0), when the infant is two months of age (Follow-up, T3).
description: Participants will be assessed with the Single-item Sleep Quality Scale (SIMP) at baseline and when the infant is two months of age (Follow-up, T3). (SIMP max-min scores=0-10, higher scores=better outcome).
arm group label: Motherly app with brief psychotherapy
arm group type: Experimental
description: Participants in this arm will receive intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition will undergo brief Cognitive-Behavioral Therapy (CBT) with a focus on behavioral activation.
arm group label: Educational app (Active control)
arm group type: Active Comparator
description: Participants in this arm will have access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they will undergo will undergo brief Cognitive-Behavioral Therapy (CBT) with a focus on behavioral activation.
intervention type: Behavioral
intervention name: Motherly 1.0
description: A mobile app designed to promote life habits that have been shown to improve physical and mental health in pregnant women. The app consists of a package of specific and customized interventions defined by eight different modules: 1) Mental Health; 2) Sleep; 3) Nutrition; 4) Physical activity; 5) Social support; 6) Prenatal support; 7) Postnatal support, and 8) Library of pre and postnatal content. The app relies on extensive psychoeducational content delivered as tutorials, brief messages, and available as a library that can be read at the users' discretion; behavior monitoring using schedules, checklists, and notifications to help participants keep track of their health care visits, and schedule behavior activation activities; and gaming elements such as changes in background appearance to reflect participant's mood assessment and ratings of activities, and graphical and easy-to-use questionnaires for obtaining information (mood, nutrition habits).
arm group label: Motherly app with brief psychotherapy
intervention type: Behavioral
intervention name: Brief Psychotherapy
description: Brief Cognitive-Behavioral Therapy (CBT) with a focus on behavioral activation (BA). Participants will be guided by psychotherapists to plan, schedule, and engage in positively reinforcing activities, and will be aided to develop problem-solving strategies for circumventing barriers to completing scheduled activities. Implementation of these techniques will be conducted with the aid of the Motherly 1.0 for participants in the experimental arm; for participants in the control arm, BA will be implemented without the aid of Motherly 1.0. Throughout the four sessions, psychotherapists will monitor participants' adherence, answering questions about the strategies and providing support for solving problems or CBT techniques, such as cognitive restructuring, relaxation techniques, sleep hygiene, stress and anxiety management, among other evidence-based techniques might be used if appropriate to the case.
arm group label: Educational app (Active control)
arm group label: Motherly app with brief psychotherapy
intervention type: Behavioral
intervention name: Educational app
description: A simplified version of the Motherly 1.0 app consisting of psychoeducational content about various aspects of pregnancy, maternal physical and mental health, and child development. Active intervention functionalities, such as behavioral activation, activity scheduling, sleep hygiene, among others, are NOT present in this simplified version of the app.
arm group label: Educational app (Active control)
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 40 Years
healthy volunteers: No
last name: Daniel Fatori, PhD
role: Principal Investigator
affiliation: Medical School, University of Sao Paulo
facility: 
country: Brazil
citation: Sockol LE, Epperson CN, Barber JP. A meta-analysis of treatments for perinatal depression. Clin Psychol Rev. 2011 Jul;31(5):839-49. doi: 10.1016/j.cpr.2011.03.009. Epub 2011 Mar 27.
PMID: 21545782
citation: Graham JW, Olchowski AE, Gilreath TD. How many imputations are really needed? Some practical clarifications of multiple imputation theory. Prev Sci. 2007 Sep;8(3):206-13. doi: 10.1007/s11121-007-0070-9. Epub 2007 Jun 5.
PMID: 17549635
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Guilherme Vanoni Polanczyk, MD PhD
investigator title: Professor
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: sample was primarily composed of highly educated women with high family income. Therefore, considering Brazil is a LMIC with inequality and widespread poverty, it is difficult to generalize our findings to other regions and countries. Study was conducted during the COVID-19 pandemic, which may have impacted participants' mental health.
point of contact: 