Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Coach-guided personalized depression risk communication to lower the chance of a major depressive episode

Official title: The Impact of Coach-guided Risk Communication on the Risk of Major Depression: A Randomized Controlled Trial

Run by Dalhousie University · NCT06619366 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment1000 (estimated)
SponsorDalhousie University
Academic / other
Locations1 site (Halifax, Nova Scotia)
StatusRecruiting
StartedFebruary 10, 2025
Main results expectedOctober 2029
Study endsOctober 2029
Registry record updatedSeptember 2, 2025
Trial IDNCT06619366 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Faculty of Medicine
    Halifax, Nova Scotia, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.