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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Faculty of Medicine
RECRUITING
Halifax
Contact Information
Primary
Jianli Wang, PhD
jianli.wang@dal.ca
902-473-6684
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2029-10
Participants
Target number of participants: 1000
Treatments
Experimental: Personalized depression risk communication
The intervention has two integrated components: PDRC and coach-guidance. The PDRC has five sections. The PDRC will be sent to participants by email/mail within two days after the baseline and follow-up assessments.~The coach will contact the participant within a week after the PDRC is provided by telephone or video conference, depending on participants' preference. The role of the coach is to assist the participant in understanding and interpreting the PDRC, answering their questions, and helping identify self-help strategies that are feasible for the participant; they do not provide psychotherapy. The coaching session will follow the four processes of motivational interview.
Active_comparator: Placebo control
Participants in the control group will receive their individualized depression risk information. Receiving individualized depression risk information is considered as control because: (1) our previous RCT showed that receiving individualized depression risk information caused no psychological harm and was effective in reducing distress and improving function; (2) Receiving depression risk information was used as control in our pilot study; (3) The pilot study suggested that the coach-guided PDRC may be more effective than receiving depression risk information alone.
Related Therapeutic Areas
Sponsors
Leads: Dalhousie University

This content was sourced from clinicaltrials.gov