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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDalhousie University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)).

Trial design

Design model

Parallel

Treatments tested in this trial

  • coach-guided personalized depression risk communication

    Other intervention

    see information in arm description.

  • depression risk information

    Other intervention

    see information in arm description.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Personalized depression risk communicationExperimental treatment 1 intervention
Group B: Placebo controlActive comparator 1 intervention

Trial outcomes

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).

Time frame
12 months after randomization.

Secondary outcomes

1

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
2

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
3

The percentage of mental health service use

The percentage of reported use of main stream mental health services

Time frame
12 months

Other outcomes

1

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
2

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

Sponsors and contacts

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