Coach-Guided Risk Communication for Major Depression

Overseen By Jianli Wang, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dalhousie University

Disqualifiers: Suicide behaviors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool designed to help prevent major depression by guiding individuals in managing their mental health. The tool, called Coach-guided Risk Communication, provides personalized insights into depression risk and suggests self-help strategies, supported by a coach. Participants will be divided into two groups: one receiving the full tool with coach guidance and another receiving only risk information. Individuals at high risk of developing depression, but not currently experiencing a major depressive episode, might be well-suited for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative mental health solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this coach-guided risk communication tool is safe for preventing depression?

Research has shown that coach-guided, personalized depression risk communication (PDRC) is safe for participants. Studies have found that receiving personalized information about depression risk does not cause psychological harm. In fact, it can reduce distress and improve functioning. In coach-guided PDRC, a coach assists participants in understanding their risk and selecting self-help methods. This approach is not therapy but aids in understanding and self-management. No negative effects have been reported, indicating that this method is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Coach-Guided Risk Communication approach for major depression because it offers a unique, personalized way to understand and manage depression risk. Unlike standard treatments like medication or traditional therapy, this method combines personalized depression risk communication with guidance from a coach. The coach helps participants understand their risk and identify practical self-help strategies through motivational interviewing, which is not typically part of standard care. This personalized, interactive approach could empower individuals to actively engage in their mental health management, potentially leading to better outcomes.

What evidence suggests that this coach-guided risk communication is effective for preventing depression?

Research has shown that a coach-guided, personalized tool for understanding depression risk (PDRC), which participants in this trial may receive, might help lower the chance of developing major depression. In earlier studies, PDRC encouraged people to take more action in self-care and seek support from others. This method shares personalized information about one's risk factors for depression and provides strategies to manage these risks. Early results suggest that this approach could be more effective than receiving general information about depression risk, which participants in the control arm of this trial will receive. If successful, this tool could offer a new way to prevent depression, especially for those at high risk. ^{1 2 3 4 5}

Who Is on the Research Team?

JianLi Wang, PhD

Principal Investigator

Dalhousie University

Are You a Good Fit for This Trial?

This trial is for Canadian adults at high risk of major depression, as determined by specific risk calculators. Participants must not currently be experiencing a major depressive episode (MDE), should have been in full remission for at least 2 months if they had a past MDE, and must understand English or French.

Inclusion Criteria

I agree to be contacted for follow-up.

I can communicate effectively in English or French.

I am at high risk for major depressive episodes according to a risk calculator.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants are assessed at baseline to determine initial risk and self-help behaviors

1 week

1 visit (in-person or virtual)

Intervention

Participants receive the coach-guided personalized depression risk communication tool (PDRC) and engage in self-help strategies

12 months

Regular contact via telephone or video conference

Follow-up

Participants are monitored for changes in depression risk, self-help behaviors, and mental health service use

12 months

Assessments at 3 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Coach-guided Risk Communication

Trial Overview The study tests a coach-guided personalized tool designed to communicate individualized depression risks and self-help strategies. It aims to motivate users towards self-help and seeking assistance, potentially reducing the onset of depression over a 12-month period.

How Is the Trial Designed?

Group I: Personalized depression risk communication Experimental Treatment 1 Intervention

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.

Group II: Placebo control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Dalhousie University

Lead Sponsor

Trials

177

Recruited

402,000+

Citations

1. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-06393-9

The impact of a coach-guided personalized depression risk ... We developed a coach-guided, personalized depression risk communication tool (PDRC) for sharing information about individualized depression risk and evidence- ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39696180/

The impact of a coach-guided personalized depression risk ... The primary objective of this project is to evaluate the impact of the PDRC on the 12-month risk of major depressive episode (MDE) in Canadians ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06619366

The Impact of Coach-guided Risk Communication on ... If successful, this coach-guided PDRC can be a novel and cost-effective program for selective prevention of depression in the Canadian general population.

4. researchgate.net researchgate.net/publication/387185021_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

The impact of a coach-guided personalized depression risk ... The primary objective of this project is to evaluate the impact of the PDRC on the 12-month risk of major depressive episode (MDE) in Canadians ...

5. withpower.com withpower.com/trial/phase-self-efficacy-10-2024-45b19

Coach-Guided Risk Communication for Major Depression 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 ...