Personalized Approach to Healthy Use and Recovery (PATH) Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Inclusion criteria for this study are intended to include most Veterans with SUD

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

Disqualifiers

exclusion criteria are being under the influence of a judgment-impairing substance at the time of consent (e.g., cannabis, alcohol, illicit opioids)

participants will be invited to return another day

being legally compelled to complete treatment

or being under civil commitment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Personal Causal Model + Personalized Feedback

    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.

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Substance use

Substance 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.

Time frame
4-, 8-, and 12-week follow-ups
2

Substance-related problems

Substance-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.

Time frame
4-, 8-, and 12-week follow-ups

Secondary outcomes

1

PTSD Symptoms

PTSD 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.

Time frame
4-, 8-, and 12-week follow-ups
2

Anxiety Symptoms

Generalized 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.

Time frame
4-, 8-, and 12-week follow-ups
3

Depression Symptoms

Beck 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.

Time frame
4-, 8-, and 12-week follow-ups

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Emory University

Collaborator

University of Minnesota

Collaborator