RecruitingNot ApplicableNCT06778096

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

Sponsor

Université de Sherbrooke

Enrollment

226 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Anxiety Postnatal Depression

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an online cognitive-behavioral therapy (CBT) program for new mothers who are experiencing both anxiety and depression symptoms after giving birth. The therapy is delivered over the internet, making it accessible from home, and researchers want to see whether it reduces symptoms compared to standard care. **You may be eligible if...** - You are 18 years of age or older - You gave birth within the past 12 months - You are fluent in spoken and written French - You have self-reported anxiety or depressive symptoms above a clinical threshold (GAD-7 ≥10 or EPDS ≥10) - You have access to a computer or tablet with internet **You may NOT be eligible if...** - You have been diagnosed with schizophrenia or bipolar disorder - You currently have a substance abuse problem - You are currently taking benzodiazepines (a type of anti-anxiety medication) - You recently started therapy (less than 4 weeks ago) or medication (less than 8 weeks ago) for depression or anxiety - You have severe depression or active thoughts of suicide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPostnatal 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.