Clinical trial NCT04441879: bBeAMom: Effectiveness of a Cognitive-Behavioral Blended Intervention for Postpartum Depression
Official title: bBeAMom Trial: A Randomized Controlled Trial to Test the Effectiveness of a Cognitive-Behavioral Blended Intervention for Postpartum Depression in Portuguese Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Depression
Keywords: Postpartum Depression
Cognitive-Behavioral Therapy
Web-Based Psychological Intervention
Blended intervention
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
First posted: 2020-06-22
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Having 18 years or more;
* 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 psychiatric comorbidity requiring alternative treatment primary to depression treatment (e.g., substance abuse, bipolar disorder);
* 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.

Primary outcomes:
measure: Changes from baseline in depressive symptoms
timeFrame: Baseline, 3 and 6 months
Secondary outcomes:
measure: Changes from baseline in anxiety symptoms
timeFrame: Baseline, 3 and 6 months
measure: Changes from baseline in quality of life
timeFrame: Baseline, 3 and 6 months
measure: Changes from baseline in the frequency of negative thoughts
timeFrame: Baseline, 3 and 6 months
measure: Changes from baseline in marital satisfaction
timeFrame: Baseline, 3 and 6 months
measure: Changes from baseline in maternal self-efficacy
timeFrame: Baseline, 3 and 6 months
measure: Changes from baseline in mother-child bonding
timeFrame: Baseline, 3 and 6 months
measure: Changes from baseline in self-compassion
timeFrame: Baseline, 3 and 6 months
measure: Changes from baseline in emotional regulation
timeFrame: Baseline, 3 and 6 months
measure: Changes from baseline in psychological flexibility
timeFrame: Baseline, 3 and 6 months
measure: Changes from baseline in expectancy for therapy
timeFrame: Baseline and 3 months
measure: Therapeutic relationship
timeFrame: 3 months
measure: Acceptability of the intervention for postpartum women
timeFrame: 3 months
measure: Usability of the intervention for postpartum women
timeFrame: 3 months
measure: Feasibility of the online program for postpartum women as measured by number of website logins
timeFrame: 3 months
measure: Feasibility of the program for postpartum women as measured by website average visit length
timeFrame: 3 months
measure: Feasibility of the intervention for postpartum women as measured by dropout rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Faculty of Psychology and Education Sciences, University of Coimbra
Study officials:
References: