<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/NCT03024645</url>
  </required_header>
  <id_info>
    <org_study_id>CINEICC-2-BaM</org_study_id>
    <secondary_id>SFRH/BPD/93996/2013</secondary_id>
    <nct_id>NCT03024645</nct_id>
  </id_info>
  <brief_title>Be a Mom: Effectiveness of a Web-based Preventive Intervention for Postpartum Depression</brief_title>
  <acronym>BeAMom</acronym>
  <official_title>Be a Mom: A Randomized Controlled Trial of the Effectiveness of a Web-based Preventive Intervention for Postpartum Depression.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Coimbra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Coimbra</source>
  <oversight_info>
    <has_dmc>No</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>
      The main goal of the research is to apply and evaluate the web-based preventive intervention&#xD;
      (the Be a Mom program), in terms of its efficacy, acceptability and feasibility (user's&#xD;
      adherence, dropout), and user's satisfaction. Prior to the randomized controlled trial (RCT),&#xD;
      the investigators will conduct a pilot trial to evaluate the preliminary version of the Be a&#xD;
      Mom program in high-risk women (random assignment to the intervention or to the control&#xD;
      condition).&#xD;
&#xD;
      The RCT will be a two-arm prevention trial. Women who have had a child during the prior month&#xD;
      will be enrolled in the study. A minimum number of 1000 women will be enrolled in the study.&#xD;
      After agreeing to participate in the study, the women will be screened for the presence of&#xD;
      risk factors for PPD and early-onset PPD symptoms (using self-report questionnaires) by a&#xD;
      researcher (licensed psychologist). In case of a negative screen, women's participation in&#xD;
      the study will end. In case of a positive screen (high-risk women), women will be randomly&#xD;
      assigned to one of the conditions: the intervention (Be a Mom program) or the control&#xD;
      condition. The sample will be recruited online and at the maternities of Coimbra University&#xD;
      Hospitals-CHUC, EPE.&#xD;
&#xD;
      Participation in the study will last 11 months. The Be a Mom program will last 5 weeks.&#xD;
      Participants in both conditions will be invited by the researchers via email to complete&#xD;
      baseline, post-intervention and follow-up (4-months and 12-months after childbirth)&#xD;
      assessments. Assessments will include self-report questionnaires to assess several indicators&#xD;
      (e.g., depressive and anxiety symptoms, dyadic adjustment, mother-child bonding, and maternal&#xD;
      confidence), mechanisms that may be involved in the treatment response (e.g., npsychological&#xD;
      flexibility, emotional regulation) and user's acceptability and satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the present study, a web-based intervention to prevent PPD (the Be a Mom program) will be&#xD;
      tested. The design and content development of the Be a Mom program was conducted through a&#xD;
      formative evaluation process (including a systematic literature review about the&#xD;
      characteristic and content of existing effective preventive interventions for PPD and a focus&#xD;
      group with stakeholders to identify the perceived needs of the target population.&#xD;
&#xD;
      Be a Mom is self-guided intervention grounded on CBT principles, and besides addressing the&#xD;
      key topics in the prevention of depression, it also addresses key content areas that are&#xD;
      associated with risk for PPD (e.g., communication skills that may help women to manage the&#xD;
      transition to motherhood). Moreover, it also includes recent developments in acceptance and&#xD;
      commitment based-therapies, specifically for the perinatal context. Be a Mom has a modular&#xD;
      set-up that is updated weekly, with each module addressing one or two specific thematic&#xD;
      contents (Changes and reorganizations during the transition to parenthood; Emotional&#xD;
      diversity; Cognitions; Relationship with others [social support and communication]; Couple&#xD;
      relationship; Signs and symptoms of depression and help-seeking). In each module,&#xD;
      participants will be provided with both psychoeducational content and therapeutic strategies.&#xD;
      Informational material will be given in text format, combined with audio, video and/or&#xD;
      animations. The Be a Mom program will also include interactive tools and feedback tools to&#xD;
      support learning.&#xD;
&#xD;
      The Be a Mom program will be delivered during the postpartum period, as this was identified&#xD;
      as privileged time for the implementation of preventive approaches for PPD. Moreover, the Be&#xD;
      a Mom program is recommended to target high-risk women (i.e., women who present antenatally&#xD;
      identified risk factors for PPD or with early-onset depressive symptoms).&#xD;
&#xD;
      The main goal of the research is to apply and evaluate the web-based preventive intervention&#xD;
      (the Be a Mom program), in terms of its efficacy, acceptability and feasibility (user's&#xD;
      adherence, dropout), and user's satisfaction. The efficacy of the program will be assessed&#xD;
      considering two indicators: a) absence of clinically significant depressive symptoms at&#xD;
      post-intervention and throughout the first postpartum year; and b) post-intervention and&#xD;
      follow-up improvements in mother's psychosocial adjustment indicators (anxiety symptoms,&#xD;
      maternal confidence and dyadic adjustment). The present study will also aim to investigate&#xD;
      the mechanisms explaining the treatment response (e.g., negative automatic thoughts,&#xD;
      psychological flexibility, self-compassion).&#xD;
&#xD;
      The research design of the trial followed the methodological recommendations for the&#xD;
      development and evaluation of web-based interventions. Prior to the randomized controlled&#xD;
      trial (RCT), a pilot trial to evaluate the preliminary version of the Be a Mom program will&#xD;
      be conducted. The pilot study will be conducted with women presenting high-risk for PPD or&#xD;
      early-onset depressive symptoms (assessed one-month postpartum through self-report&#xD;
      questionnaires). The investigators will randomly assign high-risk women to the intervention&#xD;
      (the Be a Mom program) or to the control condition, and women will be assessed at baseline&#xD;
      and post-intervention concerning adjustment outcomes, acceptability, feasibility and user's&#xD;
      satisfaction. After completing the assessments, the control group will be provided with the&#xD;
      Be a Mom program. The sample will be collected at the Maternity Daniel de Matos and Maternity&#xD;
      Bissaya Barreto (both maternities of Coimbra University Hospitals -CHUC, EPE) and online.&#xD;
      Data collection methods will include several self-administered questionnaires. Based on&#xD;
      research results the modifications will be identified and conducted to develop the final&#xD;
      version of the Be a Mom program, allowing for further efficacy studies.&#xD;
&#xD;
      The RCT will be a two-arm prevention trial, conducted in high-risk women (i.e., presenting&#xD;
      risk factors for PPD and/or early-onset postpartum depressive symptoms). The intervention&#xD;
      condition (the Be a Mom program) will be compared with a control condition (Treatment as&#xD;
      Usual). The sample will include women who delivered an healthy baby in the early postpartum&#xD;
      period (up to 3 months postpartum). Women will be enrolled both online and at the maternities&#xD;
      of Coimbra University Hospitals -CHUC, EPE. A minimum number of 150 women per condition will&#xD;
      be required (N=300). Accounting for the proportion of high-risk and low-risk women and the&#xD;
      50% of attrition rate over time, an anticipated sample of 1000 women will be enrolled in the&#xD;
      study.&#xD;
&#xD;
      A researcher (licensed psychologist) will conduct an interview with women who demonstrate&#xD;
      interest in the study, aiming to explain the study goals, the structure and arms of the&#xD;
      research and the researchers' and participants' roles. Women who agree to participate in the&#xD;
      study will sign an informed consent form. All ethical requirements for research with humans&#xD;
      are guaranteed.&#xD;
&#xD;
      After women's agreement to participate in the study, the researcher (licensed psychologist)&#xD;
      will screen women for the presence of risk factors for PPD and early-onset PPD symptoms&#xD;
      (using self-report questionnaires). In case of a negative screen, women's participation in&#xD;
      the study will end. In case of a positive screen, high-risk women will be randomly assigned&#xD;
      (blocked randomization, with allocation concealment) to one of the conditions: the&#xD;
      intervention (Be a Mom program) or the control condition. The randomization will be conducted&#xD;
      by a different researcher who will be blind to the assessment procedure.&#xD;
&#xD;
      Participation in the study will last 11 months. The Be a Mom program will last 5 weeks.&#xD;
      Participants in both conditions will be invited via email to complete baseline,&#xD;
      post-intervention and follow-up (4-months and 12-months after childbirth) assessments.&#xD;
      Assessments will include self-report questionnaires to assess several indicators (e.g.,&#xD;
      depressive and anxiety symptoms, dyadic adjustment, mother-child bonding, and maternal&#xD;
      confidence), mechanisms that may be involved in the treatment response (e.g., psychological&#xD;
      flexibility, emotional regulation) and user's acceptability and satisfaction. The necessary&#xD;
      statistical analyses will be conducted, using the intention-to-treat principles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2021</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>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of women with clinically significant postpartum depressive symptoms (EPDS &gt; 12) at 4 months postpartum</measure>
    <time_frame>4 months postpartum</time_frame>
    <description>Measured with EPDS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of women with clinically significant postpartum depressive symptoms (EPDS &gt; 12) at 12 months postpartum</measure>
    <time_frame>12 months postpartum</time_frame>
    <description>Measured with EPDS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in the severity of depressive symptoms</measure>
    <time_frame>From baseline to 12 months postpartum</time_frame>
    <description>Measured with EPDS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in anxiety symptoms</measure>
    <time_frame>From baseline to 12 months postpartum</time_frame>
    <description>Measured with Anxiety Subscale of HADS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in quality of life</measure>
    <time_frame>From baseline to 12 months postpartum</time_frame>
    <description>Measured with EQ-5D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in dyadic adjustment</measure>
    <time_frame>From baseline to 12 months postpartum</time_frame>
    <description>Measured with Dyadic Adjustment Scale - Revised</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in maternal confidence</measure>
    <time_frame>From baseline to 12 months postpartum</time_frame>
    <description>Measured with the Parental Confidence Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in the frequency of negative automatic thoughts</measure>
    <time_frame>From baseline to 12 months postpartum</time_frame>
    <description>Measured with the Postnatal Negative Thoughts Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in psychological flexibility</measure>
    <time_frame>From baseline to 12 months postpartum</time_frame>
    <description>Measured with the Acceptance and Action Questionnaire-II</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in self-criticism and self-compassion</measure>
    <time_frame>From baseline to 12 months postpartum</time_frame>
    <description>Measured with the Self-Compassion Scale (short form)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in emotional regulation</measure>
    <time_frame>From baseline to 12 months postpartum</time_frame>
    <description>Measured with the Difficulties in Emotional Regulation Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of the program for postpartum women</measure>
    <time_frame>Measured at post-intervention (2,5 months postpartum)</time_frame>
    <description>Measured through specific questions (to be developed by the researchers) to assess acceptability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of the program for postpartum women as measured by number of website logins</measure>
    <time_frame>Measured at post-intervention (2,5 months postpartum).</time_frame>
    <description>Measured through the number of user's website logins.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of the program for postpartum women as measured by website average visit length</measure>
    <time_frame>Measured at post-intervention (2,5 months postpartum).</time_frame>
    <description>Measured through the number of user's website average visit length.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of the program for postpartum women as measured by number of exercises completed</measure>
    <time_frame>Measured at post-intervention (2,5 months postpartum).</time_frame>
    <description>Measured through the total number of exercises completed by the users.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of the program for postpartum women as measured by dropout rate.</measure>
    <time_frame>Measured at post-intervention (2,5 months postpartum).</time_frame>
    <description>Measured through the number of users that dropped out from the web-based intervention before completing it.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>PostPartum Depression</condition>
  <arm_group>
    <arm_group_label>BeAMom</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-risk (HR) women will receive a web-based preventive intervention for PPD (the Be a Mom program). In addition, women will receive postpartum and and pediatric treatment as usually performed in primary care settings (TAU).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>High-risk (HR) women will receive postpartum and pediatric treatment as usually performed in primary care settings (TAU). During medical appointments, health professionals may ask women and provide information about psychological problems during the postpartum period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Be A Mom</intervention_name>
    <description>The Be a Mom program is a web-based self-guided cognitive-behavioral intervention to prevent postpartum depression, targeting postpartum women. It consists of 5 weekly modules, each module targeting a specific thematic content, and providing women with both information and specific therapeutic strategies (with a strong focus on cognitive-behavioral techniques) to address each thematic content. Modules are sequential.</description>
    <arm_group_label>BeAMom</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as usually (TAU)</intervention_name>
    <description>performed in primary care settings</description>
    <arm_group_label>BeAMom</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        General Inclusion Criteria:&#xD;
&#xD;
          -  Having 18 years or more (being an adult);&#xD;
&#xD;
          -  Being female;&#xD;
&#xD;
          -  Having had a live healthy birth in the last women, with both women and the child&#xD;
             discharged from hospital;&#xD;
&#xD;
          -  Home access to the internet.&#xD;
&#xD;
        Inclusion criteria for the High-Risk women group (to continue the participation in the&#xD;
        study):&#xD;
&#xD;
          -  Presence of risk factors for PPD (PDPI-R ≥ 5.5) and/or early-onset depressive symptoms&#xD;
             (EPDS &gt; 9);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current diagnosis of serious mental health condition (substance abuse, bipolar&#xD;
             disorder);&#xD;
&#xD;
          -  Currently receiving treatment for depressive symptoms, including antidepressant&#xD;
             medication or psychotherapy;&#xD;
&#xD;
          -  Language difficulties that impede comprehension/reading-writing;&#xD;
&#xD;
        All participants will be informed that they will be randomized to one of the study groups&#xD;
        and that will only be included if they give informed consent to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ana Fonseca, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Post-doctoral fellow at CINEICC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ana Fonseca</name>
      <address>
        <city>Coimbra</city>
        <zip>3000</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <reference>
    <citation>Fonseca, A., Pereira, M., Araújo-Pedrosa, A., Gorayeb, R., &amp; Canavarro, M. C. (2016, november). Web-based preventive intervention for postpartum depression: Development and formative evaluation of a CBT intervention. Poster presented at the IX International Congress and XIV National Congress in Clinical Psychology, Santander, Spain. https://www.researchgate.net/publication/311733757_Web-based_preventive_intervention_for_postpartum_depression_Development_and_formative_evaluation_of_a_CBT_intervention</citation>
  </reference>
  <reference>
    <citation>Fonseca, A., Pereira, M., Araújo-Pedrosa, A., Moura-Ramos, M., Gorayeb, R., &amp; Canavarro, M. C. (in press). Be a Mom: Formative evaluation of a web-based psychological intervention to prevent postpartum depression. Cognitive and Behavioral Practice. doi:10.1016/j.cbpra.2018.02.002</citation>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Coimbra</investigator_affiliation>
    <investigator_full_name>Ana Fonseca</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Postpartum Depression</keyword>
  <keyword>Cognitive-Behavioral Therapy</keyword>
  <keyword>Prevention</keyword>
  <keyword>Web-Based Psychological Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression, Postpartum</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>After the conclusion of the trial, the investigators plan to share the results of the study both with scientific community and health professionals.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03024645
org study id: CINEICC-2-BaM
secondary id: SFRH/BPD/93996/2013
nct id: NCT03024645
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main goal of the research is to apply and evaluate the web-based preventive intervention
      (the Be a Mom program), in terms of its efficacy, acceptability and feasibility (user's
      adherence, dropout), and user's satisfaction. Prior to the randomized controlled trial (RCT),
      the investigators will conduct a pilot trial to evaluate the preliminary version of the Be a
      Mom program in high-risk women (random assignment to the intervention or to the control
      condition).

      The RCT will be a two-arm prevention trial. Women who have had a child during the prior month
      will be enrolled in the study. A minimum number of 1000 women will be enrolled in the study.
      After agreeing to participate in the study, the women will be screened for the presence of
      risk factors for PPD and early-onset PPD symptoms (using self-report questionnaires) by a
      researcher (licensed psychologist). In case of a negative screen, women's participation in
      the study will end. In case of a positive screen (high-risk women), women will be randomly
      assigned to one of the conditions: the intervention (Be a Mom program) or the control
      condition. The sample will be recruited online and at the maternities of Coimbra University
      Hospitals-CHUC, EPE.

      Participation in the study will last 11 months. The Be a Mom program will last 5 weeks.
      Participants in both conditions will be invited by the researchers via email to complete
      baseline, post-intervention and follow-up (4-months and 12-months after childbirth)
      assessments. Assessments will include self-report questionnaires to assess several indicators
      (e.g., depressive and anxiety symptoms, dyadic adjustment, mother-child bonding, and maternal
      confidence), mechanisms that may be involved in the treatment response (e.g., npsychological
      flexibility, emotional regulation) and user's acceptability and satisfaction.
In the present study, a web-based intervention to prevent PPD (the Be a Mom program) will be
      tested. The design and content development of the Be a Mom program was conducted through a
      formative evaluation process (including a systematic literature review about the
      characteristic and content of existing effective preventive interventions for PPD and a focus
      group with stakeholders to identify the perceived needs of the target population.

      Be a Mom is self-guided intervention grounded on CBT principles, and besides addressing the
      key topics in the prevention of depression, it also addresses key content areas that are
      associated with risk for PPD (e.g., communication skills that may help women to manage the
      transition to motherhood). Moreover, it also includes recent developments in acceptance and
      commitment based-therapies, specifically for the perinatal context. Be a Mom has a modular
      set-up that is updated weekly, with each module addressing one or two specific thematic
      contents (Changes and reorganizations during the transition to parenthood; Emotional
      diversity; Cognitions; Relationship with others [social support and communication]; Couple
      relationship; Signs and symptoms of depression and help-seeking). In each module,
      participants will be provided with both psychoeducational content and therapeutic strategies.
      Informational material will be given in text format, combined with audio, video and/or
      animations. The Be a Mom program will also include interactive tools and feedback tools to
      support learning.

      The Be a Mom program will be delivered during the postpartum period, as this was identified
      as privileged time for the implementation of preventive approaches for PPD. Moreover, the Be
      a Mom program is recommended to target high-risk women (i.e., women who present antenatally
      identified risk factors for PPD or with early-onset depressive symptoms).

      The main goal of the research is to apply and evaluate the web-based preventive intervention
      (the Be a Mom program), in terms of its efficacy, acceptability and feasibility (user's
      adherence, dropout), and user's satisfaction. The efficacy of the program will be assessed
      considering two indicators: a) absence of clinically significant depressive symptoms at
      post-intervention and throughout the first postpartum year; and b) post-intervention and
      follow-up improvements in mother's psychosocial adjustment indicators (anxiety symptoms,
      maternal confidence and dyadic adjustment). The present study will also aim to investigate
      the mechanisms explaining the treatment response (e.g., negative automatic thoughts,
      psychological flexibility, self-compassion).

      The research design of the trial followed the methodological recommendations for the
      development and evaluation of web-based interventions. Prior to the randomized controlled
      trial (RCT), a pilot trial to evaluate the preliminary version of the Be a Mom program will
      be conducted. The pilot study will be conducted with women presenting high-risk for PPD or
      early-onset depressive symptoms (assessed one-month postpartum through self-report
      questionnaires). The investigators will randomly assign high-risk women to the intervention
      (the Be a Mom program) or to the control condition, and women will be assessed at baseline
      and post-intervention concerning adjustment outcomes, acceptability, feasibility and user's
      satisfaction. After completing the assessments, the control group will be provided with the
      Be a Mom program. The sample will be collected at the Maternity Daniel de Matos and Maternity
      Bissaya Barreto (both maternities of Coimbra University Hospitals -CHUC, EPE) and online.
      Data collection methods will include several self-administered questionnaires. Based on
      research results the modifications will be identified and conducted to develop the final
      version of the Be a Mom program, allowing for further efficacy studies.

      The RCT will be a two-arm prevention trial, conducted in high-risk women (i.e., presenting
      risk factors for PPD and/or early-onset postpartum depressive symptoms). The intervention
      condition (the Be a Mom program) will be compared with a control condition (Treatment as
      Usual). The sample will include women who delivered an healthy baby in the early postpartum
      period (up to 3 months postpartum). Women will be enrolled both online and at the maternities
      of Coimbra University Hospitals -CHUC, EPE. A minimum number of 150 women per condition will
      be required (N=300). Accounting for the proportion of high-risk and low-risk women and the
      50% of attrition rate over time, an anticipated sample of 1000 women will be enrolled in the
      study.

      A researcher (licensed psychologist) will conduct an interview with women who demonstrate
      interest in the study, aiming to explain the study goals, the structure and arms of the
      research and the researchers' and participants' roles. Women who agree to participate in the
      study will sign an informed consent form. All ethical requirements for research with humans
      are guaranteed.

      After women's agreement to participate in the study, the researcher (licensed psychologist)
      will screen women for the presence of risk factors for PPD and early-onset PPD symptoms
      (using self-report questionnaires). In case of a negative screen, women's participation in
      the study will end. In case of a positive screen, high-risk women will be randomly assigned
      (blocked randomization, with allocation concealment) to one of the conditions: the
      intervention (Be a Mom program) or the control condition. The randomization will be conducted
      by a different researcher who will be blind to the assessment procedure.

      Participation in the study will last 11 months. The Be a Mom program will last 5 weeks.
      Participants in both conditions will be invited via email to complete baseline,
      post-intervention and follow-up (4-months and 12-months after childbirth) assessments.
      Assessments will include self-report questionnaires to assess several indicators (e.g.,
      depressive and anxiety symptoms, dyadic adjustment, mother-child bonding, and maternal
      confidence), mechanisms that may be involved in the treatment response (e.g., psychological
      flexibility, emotional regulation) and user's acceptability and satisfaction. The necessary
      statistical analyses will be conducted, using the intention-to-treat principles.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Number of women with clinically significant postpartum depressive symptoms (EPDS > 12) at 4 months postpartum
time frame: 4 months postpartum
description: Measured with EPDS
measure: Number of women with clinically significant postpartum depressive symptoms (EPDS > 12) at 12 months postpartum
time frame: 12 months postpartum
description: Measured with EPDS
measure: Changes from baseline in the severity of depressive symptoms
time frame: From baseline to 12 months postpartum
description: Measured with EPDS
measure: Changes from baseline in anxiety symptoms
time frame: From baseline to 12 months postpartum
description: Measured with Anxiety Subscale of HADS
measure: Changes from baseline in quality of life
time frame: From baseline to 12 months postpartum
description: Measured with EQ-5D
measure: Changes from baseline in dyadic adjustment
time frame: From baseline to 12 months postpartum
description: Measured with Dyadic Adjustment Scale - Revised
measure: Changes from baseline in maternal confidence
time frame: From baseline to 12 months postpartum
description: Measured with the Parental Confidence Questionnaire
measure: Changes from baseline in the frequency of negative automatic thoughts
time frame: From baseline to 12 months postpartum
description: Measured with the Postnatal Negative Thoughts Questionnaire
measure: Changes from baseline in psychological flexibility
time frame: From baseline to 12 months postpartum
description: Measured with the Acceptance and Action Questionnaire-II
measure: Changes from baseline in self-criticism and self-compassion
time frame: From baseline to 12 months postpartum
description: Measured with the Self-Compassion Scale (short form)
measure: Changes from baseline in emotional regulation
time frame: From baseline to 12 months postpartum
description: Measured with the Difficulties in Emotional Regulation Scale
measure: Acceptability of the program for postpartum women
time frame: Measured at post-intervention (2,5 months postpartum)
description: Measured through specific questions (to be developed by the researchers) to assess acceptability.
measure: Feasibility of the program for postpartum women as measured by number of website logins
time frame: Measured at post-intervention (2,5 months postpartum).
description: Measured through the number of user's website logins.
measure: Feasibility of the program for postpartum women as measured by website average visit length
time frame: Measured at post-intervention (2,5 months postpartum).
description: Measured through the number of user's website average visit length.
measure: Feasibility of the program for postpartum women as measured by number of exercises completed
time frame: Measured at post-intervention (2,5 months postpartum).
description: Measured through the total number of exercises completed by the users.
measure: Feasibility of the program for postpartum women as measured by dropout rate.
time frame: Measured at post-intervention (2,5 months postpartum).
description: Measured through the number of users that dropped out from the web-based intervention before completing it.
arm group label: BeAMom
arm group type: Experimental
description: High-risk (HR) women will receive a web-based preventive intervention for PPD (the Be a Mom program). In addition, women will receive postpartum and and pediatric treatment as usually performed in primary care settings (TAU).
arm group label: Control
arm group type: Active Comparator
description: High-risk (HR) women will receive postpartum and pediatric treatment as usually performed in primary care settings (TAU). During medical appointments, health professionals may ask women and provide information about psychological problems during the postpartum period.
intervention type: Behavioral
intervention name: Be A Mom
description: The Be a Mom program is a web-based self-guided cognitive-behavioral intervention to prevent postpartum depression, targeting postpartum women. It consists of 5 weekly modules, each module targeting a specific thematic content, and providing women with both information and specific therapeutic strategies (with a strong focus on cognitive-behavioral techniques) to address each thematic content. Modules are sequential.
arm group label: BeAMom
intervention type: Other
intervention name: Treatment as usually (TAU)
description: performed in primary care settings
arm group label: BeAMom
arm group label: Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Ana Fonseca, PhD
role: Principal Investigator
affiliation: Post-doctoral fellow at CINEICC
facility: 
country: Portugal
citation: Fonseca, A., Pereira, M., Araújo-Pedrosa, A., Gorayeb, R., & Canavarro, M. C. (2016, november). Web-based preventive intervention for postpartum depression: Development and formative evaluation of a CBT intervention. Poster presented at the IX International Congress and XIV National Congress in Clinical Psychology, Santander, Spain. https://www.researchgate.net/publication/311733757_Web-based_preventive_intervention_for_postpartum_depression_Development_and_formative_evaluation_of_a_CBT_intervention
citation: Fonseca, A., Pereira, M., Araújo-Pedrosa, A., Moura-Ramos, M., Gorayeb, R., & Canavarro, M. C. (in press). Be a Mom: Formative evaluation of a web-based psychological intervention to prevent postpartum depression. Cognitive and Behavioral Practice. doi:10.1016/j.cbpra.2018.02.002
responsible party type: Principal Investigator
investigator affiliation: University of Coimbra
investigator full name: Ana Fonseca
investigator title: Principal Investigator
mesh term: Depression, Postpartum
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: Undecided
ipd description: After the conclusion of the trial, the investigators plan to share the results of the study both with scientific community and health professionals.