Recruiting

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

ClinicalTrials.gov IDNCT06778096

PhaseNA

Enrollment226

SponsorUniversité de Sherbrooke

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Anxiety, Postnatal Depression

About this study

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.

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.

Primary outcomes

Edinburgh Postnatal Depression Scale (French) (Week 0, Week 6, Week 10)
Generalised Anxiety Disorder-7 (French) (Week 0, Week 6, Week 10)

Eligibility information

Inclusion Criteria: * 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 Exclusion Criteria: * Self-reported diagnosis of schizophrenia or bipolar disorder * Current substance abuse or dependence * Current use of benzodiazepines * Beginning psychological therapy (\< 4 weeks ago) or medication (\< 8 weeks ago) for depression/anxiety * Severe depression (EPDS score ≥ 23) or active suicidal intentions (EPDS question 10 = 3, yes quite often)

Study locations

Centre intégré de santé et services sociaux de la Montérégie-Ouest, Châteauguay, Quebec Canada
Centre intégré de santé et services sociaux de la Montérégie-Est, Greenfield Park, Quebec Canada
Centre intégré de santé et services sociaux de la Montérégie-Centre, Longueuil, Quebec J4V 2H2 Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec J1H5H3 Canada

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.