Recruiting

PDRC

Sponsor:

Dalhousie University

Code:

NCT06619366

Conditions

Major Depressive Episode

Risk Reduction

Self Efficacy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

coach-guided personalized depression risk communication

depression risk information

Study Details

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.

Conditions

Major Depressive Episode

Risk Reduction

Self Efficacy

Study ID

NCT06619366

Start date

Feb 10, 2025

Status verified date

Aug, 2025

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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)).

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

coach-guided personalized depression risk communication

see information in arm description.

depression risk information

see information in arm description.

Primary outcome measure

  • The proportion of major depressive episode cases [ Time Frame: 12 months after randomization. ]

Central Contacts and Locations

Central contacts

Locations

Faculty of Medicine

Recruiting

Halifax, Nova Scotia, Canada, B3H 1V7

Contacts

More Information

Sponsor

Dalhousie University

Last update posted

Sep 2, 2025

Last verified

Aug, 2025

Keywords

  • major depressive episode
  • risk communication
  • coach-guided
  • self-help

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dalhousie University on 2025-09-02.