NCT06619366Recruiting
The Impact of Coach-guided Risk Communication on the Risk of Major Depression
The Impact of Coach-guided Risk Communication on the Risk of Major Depression: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 2 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Depression is a highly prevalent and disabling mental health problem. One way of preventing depression is to stop it before it happens through effective self-management. Working with potential users, a coach-guided, personalized depression risk communication tool (PDRC) was developed for sharing information about individualized depression risk, risk profile (risk factors present), potential risk reduction and evidence-based self-help strategies. It is anticipate that the PDRC will greatly motivate users to actively engage in self-help and help seeking, leading to a reduced risk of depression. The proposed study will recruit 500 male and 500 female adults who are at high risk of having depression across Canada, and randomly allocate them into the intervention and control groups. Participants will be followed for 12 months. The data of the trial will allow us to answer the questions: (1) Can the coach-guided PDRC reduce the risk of depression? (2) Does the intervention motivate people to actively engage in evidence-based self-help and help-seeking behaviors? (3) For whom the intervention works best? and (4) what are the costs and potential savings associated with the intervention? If successful, this project will offer a novel and effective tool for early prevention of major depression in the Canadian general population, help us understand how it works and the cost-effectiveness of implementing such a tool in the community from the economic perspective.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 25 Sept 2024
- Start date
- 10 Feb 2025
- Primary completion date
- 31 Oct 2029
- Lead sponsor
- Dalhousie University
- Diseases
- Depression
- NCT number
- NCT06619366
What you commit to
- Study type: Interventional
- Planned participants: 1000
- From 10 Feb 2025 to the primary completion date, 31 Oct 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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)).
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Medicine Coordinator of this site? Confirm its status | Halifax | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.