Coach-guided personalized depression risk communication to lower the chance of a major depressive episode
The Impact of Coach-guided Risk Communication on the Risk of Major Depression: A Randomized Controlled Trial
NA · Dalhousie University · NCT06619366
This trial will test whether a coach-guided tool that shows your personalized depression risk and recommends evidence-based self-help steps can lower the chance of a major depressive episode in adults at high risk.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Dalhousie University (other) |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT06619366 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial that will enroll about 1,000 adults (roughly 500 men and 500 women) across Canada who are at the top two deciles of predicted risk for major depressive episode. Participants will be randomly assigned to receive a coach-guided personalized depression risk communication tool or a control risk information condition and will be followed for 12 months. The intervention is built on sex-specific multivariable risk prediction algorithms derived from over 10,000 Canadians and delivers individualized risk, risk factor profiles, estimated risk reduction, and self-help recommendations with coach support. Primary outcomes include incidence of major depressive episode at 12 months, with secondary outcomes of self-help and help-seeking behaviors, symptom severity, moderation by self-efficacy, and cost-effectiveness.
Who should consider this trial
Good fit: Adults aged 18 to 65 without a current major depressive episode (or in full remission for at least 2 months) who meet high-risk thresholds on the sex-specific depression risk calculators and can communicate in English or French are the ideal candidates.
Not a fit: People with an active major depressive episode, current suicidal behaviors, inability to provide informed consent, or who cannot communicate in English or French are unlikely to benefit from this prevention-focused intervention.
Why it matters
Potential benefit: If successful, the coach-guided tool could reduce new major depressive episodes by motivating people to adopt self-help actions and seek care earlier.
How similar studies have performed: While risk communication and coach-supported behavior-change approaches have shown mixed results in other areas, this coach-guided personalized depression risk communication built on validated sex-specific prediction models is a novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * no MDE at baseline, or full remission for 2 months for those who had a past MDE (see below the question). * Aged 18 and 65 years. * At high risk of MDE based on the depression risk calculators (predicted risk of 6.5%+ for males and 11.2%+ for females), which represent the top two deciles of male and female populations in Canada. * Agreement to be contacted for follow-up assessments, and * no language barriers to English or French Exclusion Criteria: individuals who * cannot provide informed consent, * do not agree to be followed, * cannot communicate in English and French, or * report suicide behaviors (score \>0 on item 9 of the Patient Health Questionnaire (PHQ-9)).
Where this trial is running
Halifax, Nova Scotia
- Faculty of Medicine — Halifax, Nova Scotia, Canada (RECRUITING)
Study contacts
- Principal investigator: JianLi Wang, PhD — Dalhousie University
- Study coordinator: Jianli Wang, PhD
- Email: jianli.wang@dal.ca
- Phone: 902-473-6684
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Depressive Episode, Risk Reduction, Self Efficacy, major depressive episode, risk communication, coach-guided, self-help