Be a Mom: Effectiveness of an eHealth Intervention for Promoting Maternal Mental Health

NCT04055974 | Unknown

• 1 other identifier: SFRH/BD/115585/2016
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Be a mom (a web-based cognitive-behavioral intervention) is being tested in another trial as a preventive intervention in the postpartum period (NCT03024645). However, given its content and the focus on developing and strengthening psychological resources, it is important to understand if Be a Mom is also effective in promoting maternal mental health of postpartum women who are not at risk of developing postpartum depression. Thus, the main goal of this research is to apply and evaluate Be a Mom for the promotion of mental health, in terms of its efficacy, acceptability and feasibility (user's adherence, dropout), user's satisfaction and cost-effectiveness. The RCT will be a two-arm trial. Women with a child aged up to 3 months old 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 absence of risk factors for PPD (PDPI-R \< 5.5). In case of a negative screen, women will be randomly assigned to one of two conditions: the intervention (Be a Mom program) or the control condition. The sample will be recruited online. Participation in this study will last 15 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 assessments (4-months and 12-months after post-intervention). Assessments will include self-report questionnaires to assess several indicators (e.g., positive mental health, quality of life, marital satisfaction, depressive and anxiety symptoms, maternal self-efficacy), mechanisms that may be involved in the treatment response (e.g., self-compassion, emotional regulation), user's acceptability and satisfaction and cost-effectiveness.

Conditions

Mental Health Wellness 1

Keywords

positive mental health; cognitive behavioral therapy; eHealth; postpartum period

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in the presence of positive mental health

  Measured with Mental Health Continuum-SF (MHC-SF; Keyes et al., 2008). The MHC-SF can be scored continuously (scores range from 0 to 70, and higher scores indicate better positive mental health) or categorically considering mental health status (flourishing, moderate mental health, languishing)

  From baseline to postintervention (8 weeks after randomization); 4 and 8 months postintervention

Secondary Outcomes (13)

• Changes from baseline in depressive symptoms

  From baseline to postintervention (8 weeks after randomization); 4 and 8 months postintervention

• Changes from baseline in anxiety symptoms

  From baseline to postintervention (8 weeks after randomization); 4 and 8 months postintervention

• Changes from baseline in self-empowerment

  From baseline to postintervention (8 weeks after randomization); 4 months postintervention

• Changes from baseline in marital satisfaction: Marital Satisfaction Subscale of the Investment Model Scale

  From baseline to postintervention (8 weeks after randomization); 4 and 8 months postintervention

• Changes from baseline in maternal self-efficacy

  From baseline to postintervention (8 weeks after randomization); 4 and 8 months postintervention

Study Arms (2)

BeAMom

EXPERIMENTAL

Low-risk (LR) women will receive a web-based intervention for the promotion of maternal mental health (the Be a Mom program). In addition, women will receive postpartum treatment as usually performed in primary care settings (TAU).

Behavioral: Be a Mom

Control

NO INTERVENTION

Low-risk (LR) women will receive postpartum 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.

Interventions

Be a Mom BEHAVIORAL

The Be a Mom program is a web-based self-guided cognitive-behavioral intervention targeting postpartum women. It consists of 5 weekly modules, each 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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Having 18 years or more;
• Being female;
• Having had a live healthy birth in the last 3 months, with both woman and the child discharged from hospital;
• Internet access at home.
• Absence of risk factors for Postpartum Depression (PDPI-R \< 5.5).

You may not qualify if:

• Current diagnosis of serious mental health condition (e.g., substance abuse, bipolar disorder);
• Currently receiving treatment for depressive symptoms, including antidepressant medication or psychotherapy;
• Language difficulties that impede comprehension/reading-writing;

Sponsors & Collaborators

• University of Coimbra: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

Faculty of Psychology and Education Sciences, University of Coimbra

Coimbra, 3000-115, Portugal

RECRUITING

Related Publications (1)

• Monteiro F, Pereira M, Canavarro MC, Fonseca A. Be a Mom, a Web-Based Intervention to Promote Positive Mental Health Among Postpartum Women With Low Risk for Postpartum Depression: Exploring Psychological Mechanisms of Change. Front Psychiatry. 2021 Jul 14;12:701107. doi: 10.3389/fpsyt.2021.701107. eCollection 2021.

  PMID: 34335336 DERIVED

Study Officials

• Ana Fonseca, PhD

  University of Coimbra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabiana Monteiro, MsC

CONTACT

+351915580072; fgmonteiro.91@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single-blind - the investigator is unaware of the intervention assignment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: August 14, 2019
• Study Start: January 15, 2019
• Primary Completion: September 1, 2021
• Study Completion: December 31, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)