NCT06619366 The Impact of Coach-guided Risk Communication on the Risk of Major Depression
| NCT ID | NCT06619366 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dalhousie University |
| Condition | Major Depressive Episode |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2029-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2025-02-10 with a primary completion date of 2029-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)).
Contact & Investigator
JianLi Wang, PhD
PRINCIPAL INVESTIGATOR
Dalhousie University
Frequently Asked Questions
Who can join the NCT06619366 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depressive Episode. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06619366 currently recruiting?
Yes, NCT06619366 is actively recruiting participants. Contact the research team at jianli.wang@dal.ca for enrollment information.
Where is the NCT06619366 trial being conducted?
This trial is being conducted at Halifax, Canada.
Who is sponsoring the NCT06619366 clinical trial?
NCT06619366 is sponsored by Dalhousie University. The principal investigator is JianLi Wang, PhD at Dalhousie University. The trial plans to enroll 1,000 participants.