Be a Mom: Effectiveness of a Web-based Preventive Intervention for Postpartum Depression

NCT03024645 | Unknown

• 2 other identifiers: CINEICC-2-BaMSFRH/BPD/93996/2013
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PostPartum Depression

Keywords

Postpartum Depression; Cognitive-Behavioral Therapy; Prevention; Web-Based Psychological Intervention

Outcome Measures

Primary Outcomes (3)

• Number of women with clinically significant postpartum depressive symptoms (EPDS > 12) at 4 months postpartum

  Measured with EPDS

  4 months postpartum

• Number of women with clinically significant postpartum depressive symptoms (EPDS > 12) at 12 months postpartum

  Measured with EPDS

  12 months postpartum

• Changes from baseline in the severity of depressive symptoms

  Measured with EPDS

  From baseline to 12 months postpartum

Secondary Outcomes (13)

• Changes from baseline in anxiety symptoms

  From baseline to 12 months postpartum

• Changes from baseline in quality of life

  From baseline to 12 months postpartum

• Changes from baseline in dyadic adjustment

  From baseline to 12 months postpartum

• Changes from baseline in maternal confidence

  From baseline to 12 months postpartum

• Changes from baseline in the frequency of negative automatic thoughts

  From baseline to 12 months postpartum

Study Arms (2)

BeAMom

EXPERIMENTAL

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).

Behavioral: Be A Mom; Other: Treatment as usually (TAU)

Control

ACTIVE COMPARATOR

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.

Other: Treatment as usually (TAU)

Interventions

Be A Mom BEHAVIORAL

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.

BeAMom

Treatment as usually (TAU) OTHER

performed in primary care settings

BeAMom; Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Having 18 years or more (being an adult);
• Being female;
• Having had a live healthy birth in the last women, with both women and the child discharged from hospital;
• Home access to the internet.
• Presence of risk factors for PPD (PDPI-R ≥ 5.5) and/or early-onset depressive symptoms (EPDS \> 9);

You may not qualify if:

• Current diagnosis of serious mental health condition (substance abuse, bipolar disorder);
• Currently receiving treatment for depressive symptoms, including antidepressant medication or psychotherapy;
• 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.

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (1)

Ana Fonseca

Coimbra, 3000, Portugal

Location

Related Publications (3)

• 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

  BACKGROUND

• 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

  BACKGROUND

• Carona C, Pereira M, Araujo-Pedrosa A, Canavarro MC, Fonseca A. The Efficacy of Be a Mom, a Web-Based Intervention to Prevent Postpartum Depression: Examining Mechanisms of Change in a Randomized Controlled Trial. JMIR Ment Health. 2023 Mar 17;10:e39253. doi: 10.2196/39253.

  PMID: 36930182 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Ana Fonseca, PhD

  Post-doctoral fellow at CINEICC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: January 19, 2017
• Study Start: August 1, 2017
• Primary Completion: September 1, 2021
• Study Completion: December 31, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

PT (1)