The Impact of Coach-guided Risk Communication on the Risk of Major Depression

NCT06619366 | Recruiting

• 1 other identifier: 2024-7208
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The proportion of major depressive episode cases

  The proportion of new onset major depressive episode cases measured by the Composite International Diagnostic Interview (CIDI).

  12 months after randomization.

Secondary Outcomes (3)

• Depressive symptom score

  3 and 12 months

• change in self-help behaviors

  3 and 12 months

• The percentage of mental health service use

  12 months

Other Outcomes (2)

• anxiety symptom score

  3 and 12 months

• Cost reduction

  12 months

Study Arms (2)

Personalized depression risk communication

EXPERIMENTAL

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.

Other: coach-guided personalized depression risk communication

Placebo control

ACTIVE COMPARATOR

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.

Other: depression risk information

Interventions

coach-guided personalized depression risk communication OTHER

see information in arm description.

Personalized depression risk communication

depression risk information OTHER

see information in arm description.

Placebo control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)).

Sponsors & Collaborators

• Dalhousie University: lead

Study Sites (1)

Faculty of Medicine

Halifax, Nova Scotia, B3H 1V7, Canada

RECRUITING

Related Publications (1)

• Wang J, Feng C, Hajizadeh M, Lesage A. 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. BMC Psychiatry. 2024 Dec 18;24(1):916. doi: 10.1186/s12888-024-06393-9.

  PMID: 39696180 DERIVED

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• JianLi Wang, PhD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianli Wang, PhD

CONTACT

902-473-6684; jianli.wang@dal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The follow-up assessments will be conducted at the PI's telephone interview laboratory. Over the study period, investigators will be blinded to participants' group status. The survey firm interviewers who conduct baseline assessment and randomization, will not be involved in follow-up interviews. The interviewers who conduct the follow-up interviews will not have access to participants' group status. The coaches will not be involved in follow-up assessments. Given our description of study objectives, participants may know their group status. After the 12-month interview, group status will be linked with interview data by study identification numbers.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is an assessor-blinded RCT with two arms. Participants will be recruited from communities across the country, NOT from medical settings. After screening and baseline assessment, participants will be randomized into: (1) intervention, and (2) control group in a 1:1 ratio. Participants in the intervention group will receive the coach-guided PDRC.

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 1, 2024
• Study Start: February 10, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

CA (1)