Transdiagnostic Internet Cognitive-behavior Therapy for Mixed Anxiety and Depressive Symptoms in Postnatal Women
NCT06778096 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 226
Last updated 2025-05-13
Summary
This research project aims to examine the acceptability and efficacy of a French-Canadian adaptation of a postnatal anxiety and depression program. The main question it aims to answer is:
\[1\] When the adapted postnatal Internet-delivered cognitive behavioral therapy (iCBT) is added to treatment as usual (TAU) in community-based care for women with anxiety and depressive symptoms, is the iCBT+TAU condition more effective to reduce symptoms than TAU alone?
Participants will:
postnatal iCBT group -\> Answer questionnaires before, after (week 6) and 4 weeks after the intervention (week 10); do the 6-week non-guided iCBT program for anxiety and depressive symptoms during the postnatal period.
Waitlist, TAU group -\> Answer questionnaires at enrolment, at week 6 and week 10. Participants will have access to the intervention after they complete their last questionnaires.
Conditions
- Anxiety
- Postnatal Depression
Interventions
- BEHAVIORAL
-
Postnatal anxiety and depression iCBTprogram
The overarching goal of this stand-alone program is to introduce women to CBT skills to help manage symptoms of anxiety and depression, such as psychoeducation, cognitive restructuring and problem solving, behavioural activation, graded exposure and relapse prevention. Each lesson is accompanied by practical homework and resources (e.g., medication during breastfeeding, attachment and bonding, information for entourage, sleep, self-care, intrusive thought, problem solving), and is built to be easily generalizable to a broad range of women. The three lessons must be completed within a 6-week period, with up to two weeks to complete each lesson. Participants will be notified of new lessons available via email and text message reminders. There is a 5-day lockout between lessons stopping the participants to complete the next session once a session is completed to ensure that the sessions are completed over multiple weeks to allow for revision and practice.
Sponsors & Collaborators
-
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke
collaborator UNKNOWN -
Centre intégré de santé et services sociaux de la Montérégie-Centre
collaborator UNKNOWN -
Centre intégré de santé et services sociaux de la Montérégie-Ouest
collaborator UNKNOWN -
Centre intégré de santé et services sociaux de la Montérégie-Est
collaborator UNKNOWN -
Champlain Local Health Integration Network
collaborator UNKNOWN -
Université de Sherbrooke
lead OTHER
Principal Investigators
-
Pasquale Roberge, PhD · Université de Sherbrooke
-
Helen-Maria Vasiliadis, PhD · Université de Sherbrooke
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-31
- Primary Completion
- 2026-07-31
- Completion
- 2026-07-31
Countries
- Canada
Study Locations
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