Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580457
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Understanding and Treating Substance Use Disorder and Comorbid Conditions in Veterans Real-Life Settings
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Understanding and Treating Substance Use Disorder and Comorbid Conditions in Veterans Real-Life Settings
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
PATH
Brief Summary:
An important part of substance use treatment for many people is learning what triggers their substance use and urges and how they can better manage those triggers In this study the investigators will generate a model for each individual that shows likely causal links between their substance use urges and comorbid symptoms eg anxiety depression and PTSD and the investigators will examine these models as a group to draw conclusions about common causes for substance use and recovery among Veterans with substance use disorders The investigators will also test whether receiving a personal model and clinical feedback improves substance use disorder and comorbid symptom outcomes Results will include both patient-reported and statistically-determined causes of substance use for individuals and groups clinical impact of a personalized model and feedback session and participant feedback about the relevance of this study and intervention
Detailed Description:
Substance use disorders SUDs are very common in Veterans with 1 in 3 Veterans meeting criteria for a SUD each year SUDs typically occur in the context of other comorbid conditions such as depressive disorders post-traumatic stress disorder PTSD or anxiety disorders For Veterans who have comorbid conditions and SUD treatment outcomes are worse than those who have SUD only The investigators propose that the factors leading to poor SUD treatment outcomes in this population are not adequately understood and based on preliminary research vary widely by individual The investigators propose to measure SUD and comorbid symptoms multiple times daily in Veterans with SUD to characterize the connections between SUD and comorbid conditions for each individual N 74 Veterans with SUD will complete personalized 4-week ecological momentary assessment EMA protocols measuring SUD and comorbid symptoms as well as personalized items relevant to each Veterans presentation Personalized models will be estimated from each Veterans EMA data using causal discovery analyses Veterans will be randomized to either intervention or control groups The intervention group will receive their personal causal models along with an hour-long clinical feedback session based on their model The investigators will also attempt to integrate the models into any ongoing treatment and deliver follow-up reminders of key insights from their models to the intervention participants throughout the remainder of the study Follow-up measures will assess the impact of receiving this personalized intervention A subset of N 24 Veterans who were in the intervention group will be invited to share their feedback on the acceptability relevance and usefulness of the EMA protocol personal models and clinical feedback as well as thoughts on the factors that support recovery versus problematic substance use Specific aims are 1 to identify the momentary causes of substance use and urges for Veterans with SUD both individually and as a group 2 Examine the clinical impact of receiving personal causal models of substance use and urges and 3 Refine the personal causal models and clinical feedback to improve acceptability and relevance to Veterans This project will advance understanding of day-to-day maintenance mechanisms for problematic substance use in Veterans with SUD This study will create causal models of substance and comorbid symptoms at the individual level and test the impact of receiving clinical feedback based on these models Aims will be accomplished through a training plan that involves conducting VA clinical trials using causal discovery and using qualitative analyses to leverage feedback from participants
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