bBeAMom: Effectiveness of a Cognitive-Behavioral Blended Intervention for Postpartum Depression
NCT ID: NCT04441879
Last Updated: 2022-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
110 participants
INTERVENTIONAL
2022-04-01
2024-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Blended intervention
Women will receive a blended intervention (integrating face-to-face and online sessions) for the treatment of postpartum depression.
Be a Mom Coping with Depression
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.
Control (online intervention)
Women will receive an online intervention (Be a Mom program).
Be a Mom
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.
Interventions
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Be a Mom Coping with Depression
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.
Be a Mom
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.
Eligibility Criteria
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Inclusion Criteria
* Being female;
* Being Portuguese;
* Baby's age up to 12 months;
* Presence of at least 4 symptoms of a major depressive episode according to DSM-5, being one depressed mood or lost of pleasure or interest;
* Having had a live healthy birth, with both woman and the child discharged from hospital;
* Internet and computer access;
* Being able to write and read Portuguese.
Exclusion Criteria
* Presence of serious suicidal ideation;
* Presence of serious medical condition (either the participant or the baby);
* Currently receiving psychological or psychiatric treatment for depressive symptoms (antidepressant medication is allowed if stabilized for the last 3 months);
* Language difficulties that impede comprehension/reading-writing.
All participants will be informed that they will be randomized to one of the study groups and that will only be included if they give informed consent to participate in the study.
18 Years
50 Years
FEMALE
No
Sponsors
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Fundação para a Ciência e a Tecnologia
OTHER
University of Coimbra
OTHER
Responsible Party
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Ana Fonseca
Principal Investigator
Locations
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Faculty of Psychology and Education Sciences, University of Coimbra
Coimbra, , Portugal
Countries
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Central Contacts
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Facility Contacts
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References
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Branquinho M, Canavarro MC, Fonseca A. Blended CBT Intervention vs. a Guided Web-Based Intervention for Postpartum Depression: Results From a Pilot Randomized Controlled Trial. Clin Psychol Psychother. 2024 Nov-Dec;31(6):e70007. doi: 10.1002/cpp.70007.
Other Identifiers
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SFRH/BD/145563/2019
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
bBeAMom/145563/2019
Identifier Type: -
Identifier Source: org_study_id
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