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

NCT05110456 | Completed

• 1 other identifier: 2021-3210
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Postpartum

Outcome Measures

Primary Outcomes (1)

• Change from baseline at 3 month postpartum depressive symptoms: The Edinburgh Perinatal/Postnatal Depression Scale (EPDS)

  The Edinburgh Perinatal/Postnatal Depression Scale (EPDS) assesses a score between 0 and 30. A score less than 8 means depression is unlikely. A score from 9 to 11 means depression is possible. A score from 12 to 13 means high possibility of depression. A score of 14 and higher means probable depression.

  baseline (between gestational weeks 12-25) , 3 months postpartum

Secondary Outcomes (17)

• Depressive symptoms: The Edinburgh Postnatal Depression Scale (EPDS)

  6 months postpartum

• Change from baseline in Generalized Anxiety Disorder questionnaire (GAD-7) score

  baseline (between gestational weeks 12-25) , 3 and 6 months postpartum

• Anxiety related to pregnancy: Pregnancy-specific anxiety scale (PRAQ-R2)

  baseline (between gestational weeks 12-25)

• Stress: Perceived Stress Scale (PSS)

  6 months postpartum

• Well-being: WHO-5 (World Health Organization) index

  3 months postpartum

Other Outcomes (1)

• Health Service Utilization and Cost of Care Questionnaire

  6 months postpartum

Study Arms (2)

Access to an online cognitive behavioural intervention without telephone support

NO INTERVENTION

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

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

EXPERIMENTAL

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

Behavioral: Telephone support

Interventions

Telephone support 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

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

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Hewitt Foundation: collaborator

Study Sites (1)

St. Justine hospital

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (2)

• Dessy T, Montreuil TC, St-Andre M, Herba CM, MacKinnon AL, Clement M, Boucoiran I, Dinello-Goupil C, Beland J, Samson V, Tchouangue-Dinkou GD, Berard A, Morin L, Amirali L, Dennis CL, Masse B, Cote SM. Effectiveness of a web-based preventive postpartum depression programme in pregnancy, with/without telephone support: a randomised control trial. BMJ Open. 2026 Mar 11;16(3):e100835. doi: 10.1136/bmjopen-2025-100835.

  PMID: 41813052 DERIVED

• Montreuil T, Skinner J, Humez L, Gratton C, Herba CM, Cote SM. From mother to child: a protocol paper on the longitudinal effects of a perinatal intervention on maternal self-efficacy and emotion regulation and child outcomes. BMJ Open. 2026 Mar 3;16(3):e110580. doi: 10.1136/bmjopen-2025-110580.

  PMID: 41775471 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

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

Study Officials

• Sylvana Côté

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher at the research center of the university hospital of saint justine

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: November 8, 2021
• Study Start: November 9, 2021
• Primary Completion: August 30, 2024
• Study Completion: September 30, 2024
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available after publication, for up to one (1) year starting from the date of data sharing to the querent.
• Access Criteria: All data used in the current study will be shared upon reasonable request to the corresponding author, with permission of the Research Group on Psychosocial Inadaptation in Children (GRIP), and pending ethics approval.

Locations

CA (1)