Major Depressive EpisodeNCT06619366
The Impact of Coach-guided Risk Communication on the Risk of Major Depression
A study testing coach-guided personalized depression risk communication and depression risk information in people with Major Depressive Episode and Risk Reduction, run by Dalhousie University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Episode, Risk Reduction, Self Efficacy
- What is being tested?
- coach-guided personalized depression risk communication and depression risk information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 10 Feb 2025to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Halifax, Nova Scotia, B3H 1V7
JianLi Wang, PhD, 9024943575, jianli.wang@dal.ca
About this study
Official title: The Impact of Coach-guided Risk Communication on the Risk of Major Depression: A Randomized Controlled 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.
Read the detailed description
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.
- Conditions
- Major Depressive Episode, Risk Reduction, Self Efficacy
- Being tested
- coach-guided personalized depression risk communication, depression risk information
- Keywords
- major depressive episode, risk communication, coach-guided, self-help
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coach-guided personalized depression risk communicationOther
see information in arm description.
depression risk informationOther
see information in arm description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: depression risk information |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of major depressive episode cases
The proportion of new onset major depressive episode cases measured by the Composite International Diagnostic Interview (CIDI).
Measured: 12 months after randomization.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 3 and 12 months
The percentage of mental health service use
The percentage of reported use of main stream mental health services
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start10 Feb 2025
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive EpisodeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JianLi Wang, Dalhousie University
- Investigators
- JianLi Wang, PhD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619366
- Sponsor's protocol ID
- 2024-7208
- Status last verified
- Aug 2025
- First submitted
- 25 Sep 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on the nature of request.
Publications
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.
PubMed 39696180
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Coach-guided Risk Communication on the Risk of Major Depression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06619366
- Acronym / sponsor ID
- 2024-7208
- Conditions
- Major Depressive Episode, Risk Reduction, Self Efficacy
- Keywords
- major depressive episode, risk communication, coach-guided, self-help
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Personalized depression risk communication | Experimental | Other: coach-guided personalized depression risk communicationThe 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. |
| Placebo control | Active comparator | Other: depression risk informationParticipants 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 may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coach-guided personalized depression risk communicationsee information in arm description. | Other | Personalized depression risk communication |
| depression risk informationsee information in arm description. | Other | Placebo control |
Primary outcome
The proportion of major depressive episode cases
Time frame: 12 months after randomization.
The proportion of new onset major depressive episode cases measured by the Composite International Diagnostic Interview (CIDI).
3 secondary outcomes
Depressive symptom score
Time frame: 3 and 12 months
change in self-help behaviors
Time frame: 3 and 12 months
The percentage of mental health service use
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Derived from this study: PubMed 39696180Wang 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.
- Individual participant dataSharing planned: Undecided. Depending on the nature of request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
JianLi Wang, PhD principal investigator
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coach-guided personalized depression risk communication and depression risk information in people with Major Depressive Episode and Risk Reduction, run by Dalhousie University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianli Wang, PhD (902-473-6684, jianli.wang@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of major depressive episode cases (time frame: 12 months after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06619366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.