An interventional study of coach-guided personalized depression risk communication and depression risk information in Major Depressive Episode, Risk Reduction and Self Efficacy, sponsored by Dalhousie University. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by Dalhousie University · Not applicable, Interventional, and Prevention
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.
Background and importance:
Depression is a highly prevalent and disabling mental health problem. One cost-effective way of reducing the disease burden associated with depression is selective prevention, i.e., identifying individuals who are at high risk of depression, and intervene before it happens. The investigators developed the first sex-specific multivariable risk predictive algorithms (MVRPs) for major depressive episode (MDE) using data from over 10,000 Canadians. Using the MVRP as the foundation and working with future users, the investigators developed a coach-guided personalized depression risk communication tool (PDRC) for sharing information about individualized depression risk, risk profile (risk factors present), potential risk reduction and self-help strategies. It is anticipate that the coach-guided PDRC will greatly motivate users to actively engage in self-help and help-seeking, leading to a reduced risk of depression in the population.
Goals/Research Aims:
The aims of the proposed randomized controlled trial (RCT) are to evaluate the impacts of the coach-guided PDRC on: (1) the risk of MDE at 12 months, (2) self-help and help-seeking behaviors, (3) the severity of depressive symptoms, and to examine (4) the moderation effect by self-efficacy and (5) the cost effectiveness of the coach-guided PDRC.
Methods/Expertise:
The proposed RCT has two arms: (1) intervention group, receiving the coach-guided PDRC; (2) control group, receiving personalized depression risk information. The study population are male and female adults in the community who are at high risk of having an MDE. Because the tools (MVRP) for estimating the risk of having an MDE are sex-specific, the recruitment and the randomization will be conducted in males and females separately. The investigators plan to recruit and follow 500 male and 500 female adults who are at high risk across Canada random digit dialing method and social media and poster advertisement.
The participants will be assessed at baseline, 3- and 12-month to ascertain short-term and mid-term effects. Data will be analyzed in males and females, separately, controlling for the effects of covariates which include gender and gender role related variables. The investigators will examine how the intervention influences the changes in self-help and help seeking behaviors and in depressive symptoms, whether the intervention effect differ by levels of self-efficacy, and if the economic gain exceeds program-related cost. Following the CONSORT guidelines, the investigators will perform both complete case and intent-to-treat analyses based on randomization. The research team has the needed expertise for conducting the proposed RCT, including psychiatry, epidemiology, biostatistics, health economics, risk communication and large RCTs.
The expected outcomes:
In aim 1, it is expected that participants who receive the coach-guided PDRC will have a significantly lower risk of developing MDE over 12 months than those in the control group. It is expected that the intervention will significantly enhance participants' self-help and help-seeking behaviors (aim 2) and reduce depressive symptoms (aim 3). In aim 4, it is expected to observe that the intervention effect is greater in those with higher level of self-efficacy. Finally, the intervention will achieve preferable cost and saving ratio (aim 5). If successful, this coach-guided PDRC can be a novel and cost-effective program for selective prevention of depression in the Canadian general population.
291 studies on the registry are indexed under Risk Reduction Behavior; 39 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 201 across 250 interventional studies indexed under Risk Reduction Behavior.
Browse Risk Reduction Behavior studies →Dalhousie University is the lead sponsor of 52 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
individuals who
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
see information in arm description.
see information in arm description.
The proportion of major depressive episode cases
The proportion of new onset major depressive episode cases measured by the Composite International Diagnostic Interview (CIDI).
Time frame: 12 months after randomization.
Depressive symptom score
depressive symptom score measured by Patient Health Questionnaire-9. The score ranges between 0 and 27, with a higher score indicating more severe depression.
Time frame: 3 and 12 months
change in self-help behaviors
changes in self-help behavioral score measured by the Self-management Strategy Use Scale (SSUS). The SSUS assesses the frequency of using each of the 14 evidence-based self-help strategies. Frequency of use is rated on a 5-category scale. The score ranges between 14 and 70. A higher score indicates more self-help actions.
Time frame: 3 and 12 months
The percentage of mental health service use
The percentage of reported use of main stream mental health services
Time frame: 12 months
anxiety symptom score
anxiety symptom score measured by Generalized Anxiety Disorder-7. The score ranges from 0 to 21. A higher score indicates more severe anxiety.
Time frame: 3 and 12 months
Cost reduction
Sick leave and productivity measured by Health and Work Performance Questionnaire which collects information about number of sick leave days and presenteeism in the past 30 days. The number of sick leave days will be converted into monetary figure to represent cost.
Time frame: 12 months
Plan to share: Undecided — Depending on the nature of request.
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