A Randomized Study to Test a Coach-Guided Tool for Reducing Major Depression Risk in Adults Aged 18 to 65
Led by Dalhousie University · Updated on 2025-09-02
1000
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Depression is a common and disabling mental health condition. This research aims to evaluate a coach-guided personalized depression risk communication tool PDRC designed to share individualized depression risk, risk factors, potential risk reduction, and self-help strategies. The study will recruit 500 male and 500 female adults at high risk of major depressive episodes MDE across Canada to assess the tools impact on depression risk, self-help behaviors, symptom severity, and cost-effectiveness over 12 months.
Participants are randomly assigned to one of two groups the intervention group receives the coach-guided PDRC, which includes personalized risk information and coaching sessions to help understand and act on the information the control group receives individualized depression risk information alone. The PDRC is delivered by email or mail shortly after assessment, and coaching occurs via phone or video within a week. The study follows participants for one year with assessments at baseline, 3 months, and 12 months.
Throughout the study, participants complete evaluations of depression risk, symptom severity, self-help and help-seeking behaviors, and mental health service use. The research team monitors changes over time and explores how self-efficacy affects outcomes. The primary outcome is the proportion of participants developing MDE after 12 months. Secondary outcomes include depressive symptoms and engagement in self-help. The study also assesses cost and potential savings related to the intervention.
CONDITIONS
Brief Title
The Impact of Coach-guided Risk Communication on the Risk of Major Depression
Research Team
J
Jianli Wang, PhD
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No current major depressive episode at baseline or full remission for at least 2 months if previously had one
Aged between 18 and 65 years
At high risk of major depressive episode based on sex-specific depression risk calculators (6.5%+ risk for males, 11.2%+ risk for females)
Agree to be contacted for follow-up assessments
No language barriers to English or French
You will not qualify if you...
Unable to provide informed consent
Do not agree to be followed for the study
Cannot communicate in English or French
Report suicidal behaviors indicated by a score above 0 on item 9 of the PHQ-9 questionnaire
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Enrollment and Baseline Assessment
Duration - 1 day
Participants complete baseline assessments to determine initial risk and symptom levels before starting the intervention.
1 baseline visit (could be remote or in-person)
Intervention
Duration - 12 months
Participants receive either the coach-guided personalized depression risk communication or personalized depression risk information only. The coach contacts participants within a week after delivering the risk communication to provide guidance and support.
1 initial intervention delivery and coaching session, followed by ongoing self-help activities
Follow-up Assessments
Duration - 12 months
Participants complete follow-up assessments at 3 and 12 months to evaluate depressive symptoms, self-help and help-seeking behaviors, and mental health service use.
2 follow-up visits (at 3 and 12 months, remote or in-person)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
The impact of a coach-guided personalized depression risk communication program on the risk of major depressive episode: study protocol for a randomized controlled trial.