Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619366
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
The Impact of Coach-guided Risk Communication on the Risk of Major Depression
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Impact of Coach-guided Risk Communication on the Risk of Major Depression a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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 10000 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
GoalsResearch 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
MethodsExpertise
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
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 ie 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 10000 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
GoalsResearch 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
MethodsExpertise
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None