Skip to content

Personalized Approach to Healthy Use and Recovery (PATH) Trial

Understanding and Treating Substance Use Disorder and Comorbid Conditions in Veterans' Real-Life Settings

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06580457
Acronym
PATH
Enrollment
74
Registered
2024-08-30
Start date
2025-10-01
Completion date
2030-03-29
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use Disorder

Keywords

substance use disorder, precision medicine, ecological momentary assessment

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 (e.g., 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 Veteran's presentation. Personalized models will be estimated from each Veteran's 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.

Interventions

BEHAVIORALPersonal Causal Model + Personalized Feedback

Receive a personal causal model of one's personalized causes of substance use/urges, along with a 1-hour, live clinical feedback session to suggest how to apply these insights to one's own recovery.

Sponsors

Emory University
CollaboratorOTHER
University of Minnesota
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants are randomized to either intervention or control group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Inclusion criteria for this study are intended to include most Veterans with SUD * inclusion criteria are current probable SUD as indicated by: * a clinical score on the alcohol use disorders identification test (AUDIT) or drug use disorders identification test (DUDIT) * past-month substance use * a reliable access to a smartphone, tablet, or other device with capability of accessing and completing surveys throughout the day * this will exclude those who are currently completing inpatient treatment

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Substance use4-, 8-, and 12-week follow-upsSubstance use will be measured as number of days each substance was used in the past 30 days using National Survey on Drug Use and Health questions. Substances measured are nicotine, alcohol, cannabis, cocaine/crack, heroin, hallucinogens, inhalants, methamphetamine, pain relievers, tranquilizers, sedatives, and prescription stimulants. For alcohol, we will also obtain number of drinks consumed on each day, and will analyze whether average number of drinks per drinking day has changed during each follow-up period.
Substance-related problems4-, 8-, and 12-week follow-upsSubstance-related problems will be measured for the past month using the Alcohol Use Disorders Identification Test (AUDIT) and Drug Use Disorders Identification Test (DUDIT). Scores range from 0 to 40. Scores will be analyzed for changes at each follow-up point.

Secondary

MeasureTime frameDescription
PTSD Symptoms4-, 8-, and 12-week follow-upsPTSD Checklist 5 or PCL-5 measures past 30 day PTSD symptoms. Scores range from 0 to 80. Scores will be analyzed for changes at each follow-up point.
Anxiety Symptoms4-, 8-, and 12-week follow-upsGeneralized Anxiety Disorder (GAD-7) measures anxiety symptoms over the last 2 weeks. Scores range from 0 to 21. Scores will be analyzed for changes at each follow-up point.
Depression Symptoms4-, 8-, and 12-week follow-upsBeck Depression Inventory (BDI) measures depression symptoms over the last month. Scores range from 0 to 63. Scores will be analyzed for changes at each follow-up point.

Countries

United States

Contacts

Primary ContactBrittany Stevenson, PhD
Brittany.Stevenson@va.gov(612) 467-3023
Backup ContactKelvin O Lim, MD
kelvin.lim@va.gov(612) 467-3323

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026