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

May 7, 2025 updated by: Université de Sherbrooke

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

226

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Châteauguay, Quebec, Canada
      • Greenfield Park, Quebec, Canada
      • Longueuil, Quebec, Canada, J4V 2H2
      • Sherbrooke, Quebec, Canada, J1H5H3
        • Recruiting
        • Centre integre universitaire de sante et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pasquale Roberge, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • Postnatal iCBT
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edinburgh Postnatal Depression Scale (French)
Time Frame: 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.
Week 0, Week 6, Week 10
Generalised Anxiety Disorder-7 (French)
Time Frame: 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.
Week 0, Week 6, Week 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kessler Psychological Distress Scale - 10 items (French)
Time Frame: 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.
Week 0, before each program lesson (intervention group) Week 6, Week 10
Assessment of Quality of Life - 6 dimensions (French)
Time Frame: 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.
Week 0, week 6 and week 10
Maternal Postnatal Attachment Scale (French)
Time Frame: 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.
Week 0, Week 6 and Week 10

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Client Satisfaction Questionnaire (8-item French version)
Time Frame: Week 6
Tool for evaluating client's satisfaction with a service. It consists of eight items to be evaluated on a 4-point Likert scale. The score varies between 8 and 32, with a higher score indicating greater satisfaction.
Week 6
System Usability Scale
Time Frame: Week 6
It measures the efficiency of a system as well as its effectiveness perceived by users and also their satisfaction. The scale goes from 0 to 100, where a higher score indicates higher usability.
Week 6
Past health service utilization
Time Frame: Week 0 (baseline, retrospective on the past 3 months), Week 6 (post-treatment, retrospective on the past 6 weeks), Week 10 (follow-up, retrospective on the past 4 weeks)
Visits with health professionals (number, type of professionnals), previous psychotherapy for anxiety or depression (yes/no, additional true/false questions about the psychotherapy they received), medication (name). These data will be used for descriptive analysis or control variables.
Week 0 (baseline, retrospective on the past 3 months), Week 6 (post-treatment, retrospective on the past 6 weeks), Week 10 (follow-up, retrospective on the past 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

Canadian Institutes of Health Research (CIHR)
Champlain Local Health Integration Network
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke
Centre intégré de santé et services sociaux de la Montérégie-Centre
Centre intégré de santé et services sociaux de la Montérégie-Ouest
Centre intégré de santé et services sociaux de la Montérégie-Est

Investigators

  • Principal Investigator: Pasquale Roberge, PhD, Universite de Sherbrooke
  • Principal Investigator: Helen-Maria Vasiliadis, PhD, Universite de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

January 10, 2025

First Posted (Actual)

January 16, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 7, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-31-2024-5238

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets generated during the current study will not be publicly available due to ethics committee regulations, but will be available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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