Personalized Approach to Healthy Use and Recovery (PATH) Trial

NCT ID: NCT06580457

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2030-03-29

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.

Conditions

Substance Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Receive the personal causal model with a 1-hour, live clinical feedback session.

Group Type: EXPERIMENTAL

Personal Causal Model + Personalized Feedback

Intervention Type: BEHAVIORAL

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.

Control

No clinical feedback session. Personal causal models will be provided at the end of the study for those who wish to receive them.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Personal 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• participants will be invited to return another day
• being legally compelled to complete treatment
• or being under civil commitment

• due to lack of ability to give autonomous consent in these situations

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brittany Stevenson, PhD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis VA Health Care System, Minneapolis, MN

Locations

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brittany Stevenson, PhD

Role: CONTACT

Brittany.Stevenson@va.gov

(612) 467-3023

Kelvin O Lim, MD

Role: CONTACT

kelvin.lim@va.gov

(612) 467-3323

Facility Contacts

Brittany Stevenson, PhD

Role: primary

Brittany.Stevenson@va.gov

612-467-3023

Kelvin O Lim, MD

Role: backup

kelvin.lim@va.gov

(612) 467-3323

Other Identifiers

1IK2CX002716

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NURA-009-24S

Identifier Type: -

Identifier Source: org_study_id