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

St. Justine's Hospital

Status: Completed

Conditions: Depression, Postpartum

Treatments: Behavioral: Telephone support

Study type: Interventional

Funder types: Other

Identifiers

NCT05110456

2021-3210

Details and patient eligibility

About

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.

Full 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.

Enrollment: 510 patients

Sex: Female

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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510 participants in 2 patient groups

Access to an online cognitive behavioural intervention without telephone support

No Intervention group

Description:

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 group

Description:

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

Treatment:

Behavioral: Telephone support