Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06619366

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

Led by Dalhousie University · Updated on 2025-09-02

1000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

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 tool's 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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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)

Trial Site Locations

Total: 1 location

1

Faculty of Medicine

Halifax, Nova Scotia, Canada, B3H 1V7

Actively Recruiting

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Research Team

J

Jianli Wang, PhD

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.

JianLi Wang, Cindy Feng, Mohammad Hajizadeh...

https://pubmed.ncbi.nlm.nih.gov/39696180