Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351800
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-25
Brief Title:
The PredictPlusPrevent Study
Sponsor:
The Mediterranean Institute for the Advance of Biotechnology and Health Research
Organization:
The Mediterranean Institute for the Advance of Biotechnology and Health Research
Study Overview
Official Title:
Universal Prevention of Depression and Anxiety in the General Population Through a Personalized Intervention Based on Risk Algorithms ICTs and Decision Support Systems Randomized Controlled Trial The PredictPlusPrevent Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective To design develop and evaluate a personalized intervention for the universal prevention of depression and anxiety in the general population based on risk algorithms ICTs and decision support systems DSS
Methods A double-blind parallel-group randomized controlled trial with a twelve-month follow-up The entire process of recruitment random allocation intervention and follow-up will be conducted through the PredictPlusPrevent platform and its associated apps Following a media campaign at least 9000 Spanish participants aged 18 to 55 years without depression andor anxiety at baseline will be randomly assigned to the intervention or active control group PredictPlusPrevent The PredictPlusPrevent intervention will be self-guided and implemented through participants smartphones via an app it will have a biopsychosocial and multi-component approach 8 modules physical exercise improving sleep expanding relationships problem-solving improving communication assertiveness decision-making and managing thoughts The PredictPlusPrevent intervention is based on validated risk algorithms for depression and anxiety and a DSS that will help participants develop their own personalized depression prevention plans which they will implement themselves while the platform monitors and provides feedback The active control PredictPlusPrevent will include information from the risk algorithms and 24 self-help booklets The primary outcome will be the incidence of new cases of depression andor anxiety assessed using the PRIME-MD questionnaire and secondary outcomes will include reductions in depression PHQ-9 and anxiety symptoms GAD-7 probability of depression and anxiety risk predictD and predictA algorithms and physical and mental quality of life SF-12
Methods A double-blind parallel-group randomized controlled trial with a twelve-month follow-up The entire process of recruitment random allocation intervention and follow-up will be conducted through the PredictPlusPrevent platform and its associated apps Following a media campaign at least 9000 Spanish participants aged 18 to 55 years without depression andor anxiety at baseline will be randomly assigned to the intervention or active control group PredictPlusPrevent The PredictPlusPrevent intervention will be self-guided and implemented through participants smartphones via an app it will have a biopsychosocial and multi-component approach 8 modules physical exercise improving sleep expanding relationships problem-solving improving communication assertiveness decision-making and managing thoughts The PredictPlusPrevent intervention is based on validated risk algorithms for depression and anxiety and a DSS that will help participants develop their own personalized depression prevention plans which they will implement themselves while the platform monitors and provides feedback The active control PredictPlusPrevent will include information from the risk algorithms and 24 self-help booklets The primary outcome will be the incidence of new cases of depression andor anxiety assessed using the PRIME-MD questionnaire and secondary outcomes will include reductions in depression PHQ-9 and anxiety symptoms GAD-7 probability of depression and anxiety risk predictD and predictA algorithms and physical and mental quality of life SF-12
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None