<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/NCT04441879</url>
  </required_header>
  <id_info>
    <org_study_id>bBeAMom/145563/2019</org_study_id>
    <secondary_id>SFRH/BD/145563/2019</secondary_id>
    <nct_id>NCT04441879</nct_id>
  </id_info>
  <brief_title>bBeAMom: Effectiveness of a Cognitive-Behavioral Blended Intervention for Postpartum Depression</brief_title>
  <acronym>bBeAMom</acronym>
  <official_title>bBeAMom Trial: A Randomized Controlled Trial to Test the Effectiveness of a Cognitive-Behavioral Blended Intervention for Postpartum Depression in Portuguese Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Coimbra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação para a Ciência e a Tecnologia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      Be a mom program (a web-based cognitive-behavioral intervention) is being tested in another&#xD;
      clinical trial as a preventive intervention for postpartum depression (NCT03024645). However,&#xD;
      given its effectiveness in reducing depressive symptoms among women presenting early-onset&#xD;
      postpartum depressive symptoms, Be a Mom can also have potential as a postpartum depression&#xD;
      complement treatment tool. The main goal of this research is to apply and evaluate the&#xD;
      acceptability and effectiveness of a blended cognitive-behavioral intervention for the&#xD;
      treatment of postpartum depression (Be a Mom Coping with Depression) by integrating&#xD;
      face-to-face sessions with the web-based program Be a Mom.&#xD;
&#xD;
      The RCT will be a two-arm trial. Women who have had a child during the prior 12 months will&#xD;
      be enrolled in the study. A minimum number of 110 women will be enrolled in the study. After&#xD;
      agreeing to participate in the study, women will be screened and evaluated for the presence&#xD;
      of clinically significant depressive symptoms (according to DSM-5) by a researcher (licensed&#xD;
      psychologist). Participants who meet the eligibility criteria will be randomly assigned to&#xD;
      one of the conditions: the blended intervention (Be a Mom Coping with Depression) or the&#xD;
      control condition (online intervention - Be a Mom). The sample will be recruited online.&#xD;
&#xD;
      Participation in this study will last 6 months. The blended intervention will last about 3&#xD;
      months. Participants in both conditions will be invited by the researchers via email to&#xD;
      complete baseline, post-intervention and follow-up (3-months post-intervention) assessments.&#xD;
      Assessments will include self-report questionnaires to assess several indicators (e.g.,&#xD;
      depressive and anxiety symptoms, quality of life, marital satisfaction, mother-child bonding,&#xD;
      and maternal self-efficacy), mechanisms that may be involved in the treatment response (e.g.,&#xD;
      psychological flexibility, emotional regulation, and self-compassion) and user's&#xD;
      acceptability and satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the present study, a blended intervention to treat postpartum depression (Be a Mom Coping&#xD;
      with Depression) will be tested.&#xD;
&#xD;
      The main goal of this research is to apply and evaluate the acceptability and effectiveness&#xD;
      of a blended cognitive-behavioral intervention for the treatment of postpartum depression by&#xD;
      integrating face-to-face sessions with the web-based program Be a Mom. The efficacy of the&#xD;
      intervention will be assessed considering two indicators: a) decrease or absence of&#xD;
      clinically significant depressive symptoms at post-intervention and follow-up; and b)&#xD;
      post-intervention and follow-up improvements in mother's psychosocial adjustment indicators&#xD;
      (e.g., anxiety symptoms, marital satisfaction, maternal self-efficacy). The present study&#xD;
      will also aim to investigate the mechanisms explaining the treatment response (e.g.,&#xD;
      psychological flexibility, self-compassion) and characteristics moderating the treatment&#xD;
      response (e.g., motivation for therapy, therapeutic relationship).&#xD;
&#xD;
      The research design of the trial followed the methodological recommendations for the&#xD;
      development and evaluation of blended interventions. A feasibility study was conducted prior&#xD;
      to the randomized controlled trial (RCT), in order to evaluate preliminary version of the&#xD;
      blended intervention. The feasibility study was conducted with women with a clinical&#xD;
      diagnosis of postpartum depression according to the Structured Clinical Interview for DSM-5&#xD;
      (SCID-5) disorders criteria. Pre- and post-intervention assessments, using self-report&#xD;
      questionnaires, and individual interviews were used to gather information concerning&#xD;
      acceptability (relevance of contents and structure), feasibility, usability and preliminary&#xD;
      clinical effectiveness (non-controlled). Appropriate adjustments to the blended protocol were&#xD;
      carried out considering the results.&#xD;
&#xD;
      The RCT will be a two-arm trial. The intervention condition (blended intervention - Be a Mom&#xD;
      Coping with Depression) will be compared with a control condition (online intervention - Be a&#xD;
      Mom). The sample will include adult women who delivered an healthy baby in the postpartum&#xD;
      period (up to 12 months postpartum). Women will be enrolled through online recruitment. A&#xD;
      minimum number of 45 women per condition will be required (N=90). Accounting for the 20% of&#xD;
      expected attrition rate over time, an anticipated sample of 110 women will be enrolled in the&#xD;
      study.&#xD;
&#xD;
      Women who demonstrate interest in the study will be informed of the study goals, the&#xD;
      structure and arms of the research and the researchers' and participants' roles. Women who&#xD;
      agree to participate in the study will sign an informed consent form. All ethical&#xD;
      requirements for research with humans are guaranteed.&#xD;
&#xD;
      After women's agreement to participate in the study, women who have a positive screen&#xD;
      (indicating the presence of clinically relevant depressive symptoms) and meet the remaining&#xD;
      eligibility criteria, will be interviewed (SCID-5) by the researcher (licensed psychologist)&#xD;
      to assess the presence of clinically significant depressive symptoms. Women who do not&#xD;
      fulfill the eligibility criteria will end their participation in the study and will be&#xD;
      referred to intervention by local providers. Participants presenting at least 4 symptoms of a&#xD;
      major depressive episode according to DSM-5, being one depressed mood or lost of pleasure or&#xD;
      interest, with will be randomly assigned (blocked randomization, with allocation concealment)&#xD;
      to one of the conditions: the intervention (blended intervention) or the control condition&#xD;
      (online intervention).&#xD;
&#xD;
      Participation in this study will last 6 months. The blended Be a Mom intervention will last&#xD;
      about 3 months and will be conducted by the researcher (licensed psychologist). Participants&#xD;
      in both conditions will be invited by the researchers via email to complete baseline,&#xD;
      post-intervention and follow-up (3-months post-intervention) assessments. Assessments will&#xD;
      include self-report questionnaires to assess several indicators (e.g., depressive and anxiety&#xD;
      symptoms, quality of life, marital satisfaction, mother-child bonding, and maternal&#xD;
      self-efficacy), mechanisms that may be involved in the treatment response (e.g.,&#xD;
      psychological flexibility, emotional regulation, and self-compassion), and user's&#xD;
      acceptability and satisfaction. The necessary statistical analyses will be conducted, using&#xD;
      the intention-to-treat and per-protocol principles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2022</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2023</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline in depressive symptoms</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Measured with Edinburgh Postnatal Depression Scale (EPDS). The total score can range between 0 and 30, and higher scores are indicative of more severe depressive symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in anxiety symptoms</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Measured with Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS). The total score for this subscale can range between 0 and 21, and higher scores indicate more anxiety symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in quality of life</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Measured with the Euroqol Five Dimension Scale (EQ-5D). The total score is obtained through an algorithm (the digits of the answers to the five dimensions) and it describes the health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in the frequency of negative thoughts</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Measured with the Postnatal Negative Thoughts Questionnaire (PNTQ). The total score can range between 0 and 51, and higher scores indicate higher frequency of postpartum negative thoughts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in marital satisfaction</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Measured with the Satisfaction Subscale of the Investment Model Scale (IMS). The total score can range between 0 and 60, and higher scores indicate higher satisfaction with the relationship.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in maternal self-efficacy</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Measured with the Perceived Maternal Parenting Self-Efficacy Questionnaire (PMP S-E). The total score can range between 20 and 80, and higher scores are indicative of higher perceived maternal self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in mother-child bonding</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Measured with the Postpartum Bonding Questionnaire (PBQ). The total score can range between 0 and 60, and higher scores are indicative of a more impaired mother-child bond.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in self-compassion</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Measured with the Self-Compassion Scale - Short Form (SCS-SF). The total score ranges between 1 and 48, and higher scores indicate higher levels of self-compassion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in emotional regulation</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Measured with the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF). The total score can range between 18 and 90, and higher scores are indicative of more difficulties in emotion regulation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in psychological flexibility</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Measured with the Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT). The total score can range between 0 and 108, and higher scores are indicative of higher scores are indicative of higher psychological flexibility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in expectancy for therapy</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Measured with the Credibility/Expectancy Questionnaire (CEQ). Higher scores indicate greater treatment credibility and expectations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic relationship</measure>
    <time_frame>3 months</time_frame>
    <description>Measured with the Working Alliance Inventory - Short Revised (WAI-SR). The total score can range between 12 and 60, and higher scores indicate better therapeutic alliance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of the intervention for postpartum women</measure>
    <time_frame>3 months</time_frame>
    <description>Measured through specific questions (to be developed by the researchers) to assess acceptability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability of the intervention for postpartum women</measure>
    <time_frame>3 months</time_frame>
    <description>Measured through specific questions (to be developed by the researchers) to assess usability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of the online program for postpartum women as measured by number of website logins</measure>
    <time_frame>3 months</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>3 months</time_frame>
    <description>Measured through the number of user's website average visit length.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of the intervention for postpartum women as measured by dropout rate</measure>
    <time_frame>3 months</time_frame>
    <description>Measured through the number of participants that dropped out from the intervention before completing it.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Postpartum Depression</condition>
  <arm_group>
    <arm_group_label>Blended intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women will receive a blended intervention (integrating face-to-face and online sessions) for the treatment of postpartum depression.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (online intervention)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women will receive an online intervention (Be a Mom program).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Be a Mom Coping with Depression</intervention_name>
    <description>Be a Mom Coping with Depression is a blended cognitive-behavioral intervention for the treatment of postpartum depression. It consists of 13 weeks of face-to-face and online sessions, each session targeting a specific thematic content, and providing participants with both information and specific therapeutic strategies (with a strong focus on cognitive-behavioral techniques) to address each thematic content.</description>
    <arm_group_label>Blended intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Be a Mom</intervention_name>
    <description>Be a Mom is an online intervention consisting of 6 modules, each one 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. Women will receive biweekly phone calls from a psychologist between completion of each module to provide support.</description>
    <arm_group_label>Control (online intervention)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having 18 years or more;&#xD;
&#xD;
          -  Being female;&#xD;
&#xD;
          -  Being Portuguese;&#xD;
&#xD;
          -  Baby's age up to 12 months;&#xD;
&#xD;
          -  Presence of at least 4 symptoms of a major depressive episode according to DSM-5,&#xD;
             being one depressed mood or lost of pleasure or interest;&#xD;
&#xD;
          -  Having had a live healthy birth, with both woman and the child discharged from&#xD;
             hospital;&#xD;
&#xD;
          -  Internet and computer access;&#xD;
&#xD;
          -  Being able to write and read Portuguese.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of psychiatric comorbidity requiring alternative treatment primary to&#xD;
             depression treatment (e.g., substance abuse, bipolar disorder);&#xD;
&#xD;
          -  Presence of serious suicidal ideation;&#xD;
&#xD;
          -  Presence of serious medical condition (either the participant or the baby);&#xD;
&#xD;
          -  Currently receiving psychological or psychiatric treatment for depressive symptoms&#xD;
             (antidepressant medication is allowed if stabilized for the last 3 months);&#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_contact>
    <last_name>Mariana Branquinho</last_name>
    <phone>912979399</phone>
    <phone_ext>+351</phone_ext>
    <email>marianacjbranquinho@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Psychology and Education Sciences, University of Coimbra</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-115</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mariana Branquinho</last_name>
      <phone>912979399</phone>
      <phone_ext>+351</phone_ext>
      <email>marianacjbranquinho@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>July 13, 2022</last_update_submitted>
  <last_update_submitted_qc>July 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2022</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>Web-Based Psychological Intervention</keyword>
  <keyword>Blended 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/NCT04441879
org study id: bBeAMom/145563/2019
secondary id: SFRH/BD/145563/2019
nct id: NCT04441879
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Be a mom program (a web-based cognitive-behavioral intervention) is being tested in another
      clinical trial as a preventive intervention for postpartum depression (NCT03024645). However,
      given its effectiveness in reducing depressive symptoms among women presenting early-onset
      postpartum depressive symptoms, Be a Mom can also have potential as a postpartum depression
      complement treatment tool. The main goal of this research is to apply and evaluate the
      acceptability and effectiveness of a blended cognitive-behavioral intervention for the
      treatment of postpartum depression (Be a Mom Coping with Depression) by integrating
      face-to-face sessions with the web-based program Be a Mom.

      The RCT will be a two-arm trial. Women who have had a child during the prior 12 months will
      be enrolled in the study. A minimum number of 110 women will be enrolled in the study. After
      agreeing to participate in the study, women will be screened and evaluated for the presence
      of clinically significant depressive symptoms (according to DSM-5) by a researcher (licensed
      psychologist). Participants who meet the eligibility criteria will be randomly assigned to
      one of the conditions: the blended intervention (Be a Mom Coping with Depression) or the
      control condition (online intervention - Be a Mom). The sample will be recruited online.

      Participation in this study will last 6 months. The blended intervention will last about 3
      months. Participants in both conditions will be invited by the researchers via email to
      complete baseline, post-intervention and follow-up (3-months post-intervention) assessments.
      Assessments will include self-report questionnaires to assess several indicators (e.g.,
      depressive and anxiety symptoms, quality of life, marital satisfaction, mother-child bonding,
      and maternal self-efficacy), mechanisms that may be involved in the treatment response (e.g.,
      psychological flexibility, emotional regulation, and self-compassion) and user's
      acceptability and satisfaction.
In the present study, a blended intervention to treat postpartum depression (Be a Mom Coping
      with Depression) will be tested.

      The main goal of this research is to apply and evaluate the acceptability and effectiveness
      of a blended cognitive-behavioral intervention for the treatment of postpartum depression by
      integrating face-to-face sessions with the web-based program Be a Mom. The efficacy of the
      intervention will be assessed considering two indicators: a) decrease or absence of
      clinically significant depressive symptoms at post-intervention and follow-up; and b)
      post-intervention and follow-up improvements in mother's psychosocial adjustment indicators
      (e.g., anxiety symptoms, marital satisfaction, maternal self-efficacy). The present study
      will also aim to investigate the mechanisms explaining the treatment response (e.g.,
      psychological flexibility, self-compassion) and characteristics moderating the treatment
      response (e.g., motivation for therapy, therapeutic relationship).

      The research design of the trial followed the methodological recommendations for the
      development and evaluation of blended interventions. A feasibility study was conducted prior
      to the randomized controlled trial (RCT), in order to evaluate preliminary version of the
      blended intervention. The feasibility study was conducted with women with a clinical
      diagnosis of postpartum depression according to the Structured Clinical Interview for DSM-5
      (SCID-5) disorders criteria. Pre- and post-intervention assessments, using self-report
      questionnaires, and individual interviews were used to gather information concerning
      acceptability (relevance of contents and structure), feasibility, usability and preliminary
      clinical effectiveness (non-controlled). Appropriate adjustments to the blended protocol were
      carried out considering the results.

      The RCT will be a two-arm trial. The intervention condition (blended intervention - Be a Mom
      Coping with Depression) will be compared with a control condition (online intervention - Be a
      Mom). The sample will include adult women who delivered an healthy baby in the postpartum
      period (up to 12 months postpartum). Women will be enrolled through online recruitment. A
      minimum number of 45 women per condition will be required (N=90). Accounting for the 20% of
      expected attrition rate over time, an anticipated sample of 110 women will be enrolled in the
      study.

      Women who demonstrate interest in the study will be informed of 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, women who have a positive screen
      (indicating the presence of clinically relevant depressive symptoms) and meet the remaining
      eligibility criteria, will be interviewed (SCID-5) by the researcher (licensed psychologist)
      to assess the presence of clinically significant depressive symptoms. Women who do not
      fulfill the eligibility criteria will end their participation in the study and will be
      referred to intervention by local providers. Participants presenting at least 4 symptoms of a
      major depressive episode according to DSM-5, being one depressed mood or lost of pleasure or
      interest, with will be randomly assigned (blocked randomization, with allocation concealment)
      to one of the conditions: the intervention (blended intervention) or the control condition
      (online intervention).

      Participation in this study will last 6 months. The blended Be a Mom intervention will last
      about 3 months and will be conducted by the researcher (licensed psychologist). Participants
      in both conditions will be invited by the researchers via email to complete baseline,
      post-intervention and follow-up (3-months post-intervention) assessments. Assessments will
      include self-report questionnaires to assess several indicators (e.g., depressive and anxiety
      symptoms, quality of life, marital satisfaction, mother-child bonding, and maternal
      self-efficacy), mechanisms that may be involved in the treatment response (e.g.,
      psychological flexibility, emotional regulation, and self-compassion), and user's
      acceptability and satisfaction. The necessary statistical analyses will be conducted, using
      the intention-to-treat and per-protocol principles.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes from baseline in depressive symptoms
time frame: Baseline, 3 and 6 months
description: Measured with Edinburgh Postnatal Depression Scale (EPDS). The total score can range between 0 and 30, and higher scores are indicative of more severe depressive symptoms.
measure: Changes from baseline in anxiety symptoms
time frame: Baseline, 3 and 6 months
description: Measured with Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS). The total score for this subscale can range between 0 and 21, and higher scores indicate more anxiety symptomatology.
measure: Changes from baseline in quality of life
time frame: Baseline, 3 and 6 months
description: Measured with the Euroqol Five Dimension Scale (EQ-5D). The total score is obtained through an algorithm (the digits of the answers to the five dimensions) and it describes the health state.
measure: Changes from baseline in the frequency of negative thoughts
time frame: Baseline, 3 and 6 months
description: Measured with the Postnatal Negative Thoughts Questionnaire (PNTQ). The total score can range between 0 and 51, and higher scores indicate higher frequency of postpartum negative thoughts.
measure: Changes from baseline in marital satisfaction
time frame: Baseline, 3 and 6 months
description: Measured with the Satisfaction Subscale of the Investment Model Scale (IMS). The total score can range between 0 and 60, and higher scores indicate higher satisfaction with the relationship.
measure: Changes from baseline in maternal self-efficacy
time frame: Baseline, 3 and 6 months
description: Measured with the Perceived Maternal Parenting Self-Efficacy Questionnaire (PMP S-E). The total score can range between 20 and 80, and higher scores are indicative of higher perceived maternal self-efficacy.
measure: Changes from baseline in mother-child bonding
time frame: Baseline, 3 and 6 months
description: Measured with the Postpartum Bonding Questionnaire (PBQ). The total score can range between 0 and 60, and higher scores are indicative of a more impaired mother-child bond.
measure: Changes from baseline in self-compassion
time frame: Baseline, 3 and 6 months
description: Measured with the Self-Compassion Scale - Short Form (SCS-SF). The total score ranges between 1 and 48, and higher scores indicate higher levels of self-compassion.
measure: Changes from baseline in emotional regulation
time frame: Baseline, 3 and 6 months
description: Measured with the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF). The total score can range between 18 and 90, and higher scores are indicative of more difficulties in emotion regulation.
measure: Changes from baseline in psychological flexibility
time frame: Baseline, 3 and 6 months
description: Measured with the Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT). The total score can range between 0 and 108, and higher scores are indicative of higher scores are indicative of higher psychological flexibility.
measure: Changes from baseline in expectancy for therapy
time frame: Baseline and 3 months
description: Measured with the Credibility/Expectancy Questionnaire (CEQ). Higher scores indicate greater treatment credibility and expectations.
measure: Therapeutic relationship
time frame: 3 months
description: Measured with the Working Alliance Inventory - Short Revised (WAI-SR). The total score can range between 12 and 60, and higher scores indicate better therapeutic alliance.
measure: Acceptability of the intervention for postpartum women
time frame: 3 months
description: Measured through specific questions (to be developed by the researchers) to assess acceptability.
measure: Usability of the intervention for postpartum women
time frame: 3 months
description: Measured through specific questions (to be developed by the researchers) to assess usability.
measure: Feasibility of the online program for postpartum women as measured by number of website logins
time frame: 3 months
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: 3 months
description: Measured through the number of user's website average visit length.
measure: Feasibility of the intervention for postpartum women as measured by dropout rate
time frame: 3 months
description: Measured through the number of participants that dropped out from the intervention before completing it.
arm group label: Blended intervention
arm group type: Experimental
description: Women will receive a blended intervention (integrating face-to-face and online sessions) for the treatment of postpartum depression.
arm group label: Control (online intervention)
arm group type: Active Comparator
description: Women will receive an online intervention (Be a Mom program).
intervention type: Behavioral
intervention name: Be a Mom Coping with Depression
description: Be a Mom Coping with Depression is a blended cognitive-behavioral intervention for the treatment of postpartum depression. It consists of 13 weeks of face-to-face and online sessions, each session targeting a specific thematic content, and providing participants with both information and specific therapeutic strategies (with a strong focus on cognitive-behavioral techniques) to address each thematic content.
arm group label: Blended intervention
intervention type: Behavioral
intervention name: Be a Mom
description: Be a Mom is an online intervention consisting of 6 modules, each one 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. Women will receive biweekly phone calls from a psychologist between completion of each module to provide support.
arm group label: Control (online intervention)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Mariana Branquinho
phone: 912979399
phone ext: +351
email: marianacjbranquinho@hotmail.com
facility: 
status: Recruiting
contact: 
country: Portugal
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.