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

Not Applicable

Recruiting

• Conditions: Anxiety; Postnatal Depression

• Registration Number: NCT06778096
• Lead Sponsor: Université de Sherbrooke

Brief 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.

Detailed Description

Background. Nearly 20% of women will be confronted with anxiety or depressive disorders during the perinatal period and this may lead to adverse outcomes for both mother and child. Cognitive behavioural therapy (CBT) is the psychological intervention with the most empirical support for the clinical management of anxiety and depressive disorders. Depression and anxiety frequently occur in women during the perinatal period, and there is growing evidence that internet-delivered CBT (iCBT) could be an acceptable and effective intervention. ThisWayUp iCBT Virtual Clinic in Australia has developed a program for postnatal anxiety and depression. As part of a Québec-Ontario collaboration, this research protocol aims to examine the acceptability and efficacy of a French-Canadian adaptation of the postnatal anxiety and depression program. Methods/Design. The investigators propose to conduct a hybrid type 1 randomized clinical trial and implementation study to replicate the findings of the trial conducted in Australia as well as explore barriers and facilitators to potential large-scale implementation. Treatment and control groups. a) adapted postnatal depression and anxiety iCBT program (3 lessons to complete in six weeks) added to treatment-as-usual (TAU); b) TAU. Participants will include women with possible postnatal depression or anxiety as per the Generalized Anxiety Disorder-7 (GAD-7) or the Edinburgh Postnatal Depression Scale (EPDS). The primary outcome measures will be the GAD-7 and the EPDS. Secondary outcome measures will comprise self-reported instruments to evaluate mother-child experience, postnatal depression, psychological distress, suicidality risk, quality of life, treatment satisfaction and service utilization. Statistical analysis. Statistical analysis will follow intent-to-treat principles. A mixed model regression approach will be used to account for between- and within-subject variations in the analysis of the longitudinal effects of iCBT compared to TAU intervention. Moderation analyses will be performed for three sets of moderators: clinical characteristics, previous treatments and sociodemographic characteristics. Additionally, treatment effect sizes will be calculated with Cohen's d. Discussion. The study will deliver important data of efficacy and acceptability to patients, clinicians, and decision-makers to inform the scaling-up of the postnatal iCBT intervention. The benefits to patients could include timely access to services, improved remission rates and health-related quality of life, better long-term outcomes; and to the healthcare system, policy and decision-makers: improved efficiency, optimization of resources, and this to meet the perinatal women and child needs equitably.

Study Timeline

• Study First Submitted: 2024-12-23
• Study First Submitted QC: 2025-01-10
• Study First Posted: 2025-01-16
• Status Verified: 2025-05
• Study Start: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 226

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Edinburgh Postnatal Depression Scale (French)	Week 0, Week 6, Week 10	Used to evaluate postpartum depression. 10 items, 0 to 3 Likert scale, retrospective on the past 7 days. The score varies between 0 and 30, with a higher score indicating more severe symptoms.
Generalised Anxiety Disorder-7 (French)	Week 0, Week 6, Week 10	Used to evaluate the severity of anxiety symptoms. 7 items, 0 to 3 Likert scale, retrospective on the past 14 days. The score varies between 0 and 21, with a higher score indicating more severe symptoms.

Secondary Outcome Measures

Name	Time	Method
Kessler Psychological Distress Scale - 10 items (French)	Week 0, before each program lesson (intervention group) Week 6, Week 10	Used to evaluate psychological distress. 10 items, 1 to 5 Likert scale, retrospective on the past 14 days. The score varies between 10 and 50, with a higher score indicating more psychological distress.
Assessment of Quality of Life - 6 dimensions (French)	Week 0, week 6 and week 10	20-item self-administered health-related quality of life tool, retrospective over the past week, to be rated on Likert scales with varying number of levels. It assesses six dimensions: independent living, mental health, coping, relationships, pain, senses. Response options for each item range from 4-6 levels. Scores on each domain and a total score can be derived. Standardized scores range from 0 to 100 where higher scores indicate less quality of life impairment.
Maternal Postnatal Attachment Scale (French)	Week 0, Week 6 and Week 10	19-item self-report questionnaire to assess the affective aspect of mother-infant bonding over the past 2 weeks. It is based on three subscales: absence of hostility, pleasure in interaction and quality of attachment. The score varies between 19 and 95; lower scores indicate more problematic responses.

Trial Locations

Locations (4)

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, Canada

Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada