To Evaluate the Effectiveness of a Virtual and Telephone Intervention for the Prevention of Postpartum Depression in Women at Risk

NCT ID: NCT05110456

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 510 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-09
• Study Completion Date: 2024-09-30

Brief Summary

Women's perinatal mental health problems can create a cascade of short- and long-term negative influences for the mother, child, and the family as a whole. To prevent these impacts, preventive online and telephone interventions exist, but need to be tested and improved to develop this type of support to women in Quebec. The Parents & Babies program, which is a distance learning course, followed during pregnancy and accompanied by telephone follow-up, aims to improve the mental health of future parents.The investigators seek to evaluate the effect of the intervention of the Parents & Babies program offered with telephone support compared to the course offered without telephone follow-up.

Detailed Description

The Parents & Babies intervention to be evaluated is an adaptation of the existing, evidence-based Mothers & Babies program which has shown efficacy in four clinical trials for the prevention of postpartum depression through in-person (group or individual) counseling

The Parents & Babies program was adapted to be virtual and include: 1) specific modules for the mother-partner dyad; 2) third-wave cognitive behavioral therapy (CBT) strategies targeting well-being, relaxation, mindfulness, self-compassion, and gratitude; 3) confinement and social distancing related material. Participants follow the program online or with a paper workbook and are called weekly by a member of the intervention team.

Participants will fill out three questionnaires (online or by telephone) at 12-25 weeks' gestation, 3 months' postpartum and 6-months postpartum to assess baseline values and trial outcomes, respectively.

Conditions

Depression, Postpartum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Access to an online cognitive behavioural intervention without telephone support

The control group will receive a fully automated version of the virtual intervention without telephone support

Group Type: NO_INTERVENTION

No interventions assigned to this group

Cognitive-Behavioral Therapy (CBT) and interpersonal counseling with telephone support.

The experimental group will receive an online cognitive behavioural intervention with weekly telephone support

Group Type: EXPERIMENTAL

Telephone support

Intervention Type: BEHAVIORAL

Participants will receive 10 telephone counseling calls by trained coaches: 9 during pregnancy (one call/week) and 1 at 6 weeks postpartum. We have included individual telephone calls by a trained coaches aimed to :

1. encourage the use of online material;

2. identify strategies for overcoming obstacles;

3. help apply content to real-life settings; and

4. underscore the participants' success in using effective coping strategies

Interventions

Telephone support

Participants will receive 10 telephone counseling calls by trained coaches: 9 during pregnancy (one call/week) and 1 at 6 weeks postpartum. We have included individual telephone calls by a trained coaches aimed to :

1. encourage the use of online material;

2. identify strategies for overcoming obstacles;

3. help apply content to real-life settings; and

4. underscore the participants' success in using effective coping strategies

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Pregnant women (12-25 weeks' gestation)
• subclinical and clinical levels of depression (Edinburgh Postnatal Depression Scale (EPDS) scores 8-16)
• ability to read and understand French.

Exclusion Criteria

• EPDS score in the clinical range (≥ 17) or no symptoms (EPDS < 8)
• Positive screening of psychotic symptoms using the Psychosis Screening Questionnaire (PSQ)
• self-reported substance abuse problems.

• Minimum Eligible Age: 14 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hewitt Foundation

UNKNOWN

Sponsor Role: collaborator

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sylvana M Côté

Researcher at the research center of the university hospital of saint justine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sylvana Côté

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

St. Justine hospital

Montreal, Quebec, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2021-3210

Identifier Type: -

Identifier Source: org_study_id