Transdiagnostic Internet Cognitive-behavior Therapy for Mixed Anxiety and Depressive Symptoms in Postnatal Women
Key facts
- Who runs it
- Université de Sherbrooke
- Where
- Canada4 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 226 people, planned
- Started
- May 2025
- Planned end
- Jul 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Postnatal anxiety and depression iCBTprogram
- Record updated
- 13 May 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- Beginning psychological therapy (< 4 weeks ago) or medication (< 8 weeks ago) for depression/anxiety
- Self-reported diagnosis of schizophrenia or bipolar disorder
- Current substance abuse or dependence
- Current use of benzodiazepines
- Severe depression (EPDS score ≥ 23) or active suicidal intentions (EPDS question 10 = 3, yes quite often)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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:
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[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.
The 2 groups in the trial
- The postnatal anxiety and depression iCBTprogram + TAUTreatment being tested
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.
Treatment: Postnatal anxiety and depression iCBTprogram
- Treatment-as-usualNo study treatment, for comparison
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Publications
- Record updated
- 13 May 2025