Transdiagnostic Internet Cognitive-behavior Therapy for Mixed Anxiety and Depressive Symptoms in Postnatal Women

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years and older

• Being within 12 months postpartum

• Fluent in spoken and written French

• Self-reported clinical score ≥10 for anxiety and/or depressive symptoms based on the Generalised Anxiety Disorder-7 (GAD-7) and the Edinburgh Postnatal Depression Scale 10-item scale (EPDS)

• Access to a computer/tablet and internet connection

• Agreement to share primary provider contact information

Locations
Other Locations
Canada
Centre intégré de santé et services sociaux de la Montérégie-Ouest
RECRUITING
Châteauguay
Centre intégré de santé et services sociaux de la Montérégie-Est
RECRUITING
Greenfield Park
Centre intégré de santé et services sociaux de la Montérégie-Centre
RECRUITING
Longueuil
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke
RECRUITING
Sherbrooke
Contact Information
Primary
Pasquale Roberge, PhD
Pasquale.Roberge@USherbrooke.ca
819 821-8000
Backup
Alexandra Chapdelaine, PhD
Alexandra.Chapdelaine@USherbrooke.ca
819-821-8000
Time Frame
Start Date: 2025-05
Estimated Completion Date: 2026-07
Participants
Target number of participants: 226
Treatments
Experimental: The postnatal anxiety and depression iCBTprogram + TAU
Women will have access to the postnatal iCBT program (self-directed) and will have to complete the program over six weeks. They still can have contacts with the healthcare system.
No_intervention: Treatment-as-usual
No restrictions will be imposed regarding usual care. To reflect heterogeneity of health seeking behaviour and mental health practices for anxiety and depressive symptoms in the community during the postpartum period, participants will not be constrained to a prespecified usual care treatment for external validity or have contacts with the healthcare system. Data will be collected on throughout the trial. This group will have a delayed access to the program after they complete their four-week follow-up questionnaire.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Centre intégré de santé et services sociaux de la Montérégie-Ouest, Centre intégré de santé et services sociaux de la Montérégie-Est, Centre intégré de santé et services sociaux de la Montérégie-Centre, Champlain Local Health Integration Network, Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke
Leads: Université de Sherbrooke

This content was sourced from clinicaltrials.gov