Personalized Feedback for Substance Use Disorder

(PATH Trial)

Overseen By Brittany Stevenson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Inpatient treatment, Civil commitment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Veterans with a substance use disorder by identifying triggers for their substance use and exploring better management strategies. It will develop a personalized model for each participant, illustrating the connections between their substance use and other symptoms like anxiety or depression. Some participants will receive feedback on their model (Personal Causal Model + Personalized Feedback) to determine if it aids in improving their substance use and overall well-being. Veterans who have used substances in the past month and have access to a smartphone or tablet are well-suited for this study. As an unphased trial, this study provides Veterans with a unique opportunity to gain personalized insights into their substance use and enhance their well-being.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this personalized feedback method is safe for individuals with substance use disorder?

Research has shown that personalized feedback and personal cause-and-effect models are generally safe for individuals with substance use issues. Most studies have focused on the effectiveness of these methods rather than their safety, resulting in limited detailed safety information. However, since these methods involve only discussion and feedback without physical procedures, they are considered low-risk. This trial is labeled as "Not Applicable" for phase, indicating it does not test a new drug or high-risk treatment. Participants can feel confident that this approach is well-tolerated and has no known harmful effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a personalized approach to treating Substance Use Disorder (SUD). Unlike traditional treatments that often rely on medication or standardized therapy sessions, this trial uses a Personal Causal Model combined with Personalized Feedback to tailor interventions to the individual's unique experiences and needs. This innovative method aims to provide a more targeted and effective intervention by addressing the specific factors contributing to a person's substance use. By focusing on personalized insights, the trial hopes to enhance treatment outcomes and provide deeper understanding for both patients and clinicians.

What evidence suggests that this trial's personalized feedback treatment could be effective for substance use disorder?

Research has shown that personalized feedback can help reduce alcohol consumption and related issues, particularly among college students. Other studies suggest that while personalized feedback has a small effect on drinking habits, it may not significantly reduce heavy drinking episodes. Additionally, care focusing on individual needs and feedback generally leads to better results in treating substance use disorders. In this trial, participants in the intervention arm will receive a personal causal model with a 1-hour, live clinical feedback session. This approach suggests that personalized feedback and care might help manage these disorders by addressing personal triggers and behaviors. Overall, a personalized approach, especially when combined with clinical feedback, shows promise in helping people with substance use disorders. ^{1 3 6 7 8}

Who Is on the Research Team?

Brittany Stevenson, PhD

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Are You a Good Fit for This Trial?

This trial is for veterans with substance use disorders who want to understand and manage their triggers. It's important that participants have co-occurring conditions like anxiety, depression, or PTSD. The study requires them to be open to receiving personalized feedback based on a model created from their experiences.

Inclusion Criteria

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

Current probable SUD as indicated by a clinical score on the alcohol use disorders identification test (AUDIT) or drug use disorders identification test (DUDIT)

Reliable access to a smartphone, tablet, or other device with capability of accessing and completing surveys throughout the day (excluding those who are currently completing inpatient treatment)

Exclusion Criteria

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)

I am not under legal obligation to complete treatment or civil commitment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ecological Momentary Assessment (EMA)

Participants complete personalized 4-week EMA protocols measuring SUD and comorbid symptoms

4 weeks

Daily assessments

Intervention

Intervention group receives personal causal models with a 1-hour clinical feedback session

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for changes in substance use, depression, PTSD, and anxiety symptoms

12 weeks

Follow-up assessments at 4, 8, and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Personal Causal Model + Personalized Feedback

Trial Overview The study tests if creating a personal causal model of an individual's substance use and providing feedback can help improve the management of substance use disorder and related symptoms. Participants will receive models showing potential causes for their behavior and recovery patterns.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

Individuals who consume higher amounts of alcohol are more likely to choose to receive personalized feedback about their drinking habits, with 85% of participants consistently opting in across two time points.

Receiving feedback led to a small reduction in peak alcohol consumption among heavy drinkers over a 30-day period, suggesting that personalized interventions may help reduce drinking intensity, although further research is needed to confirm these findings in more diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who Opts In to Alcohol Feedback and How Does That Impact Behavior? A Pilot Trial. Boness, CL., Helle, AC., Miller, MB., et al.[2023]

A study of 1244 opioid-dependent individuals found that those who stopped naltrexone treatment experienced significantly higher overdose rates (39 overdoses per 100 person-years) compared to those who left agonist treatments, indicating a critical risk period immediately after stopping naltrexone.

Overall, individuals who left any pharmacotherapy for opioid dependence had much higher rates of serious adverse events and deaths (six per 100 person-years) compared to when they were in treatment, highlighting the need for ongoing support and risk education after treatment cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). Digiusto, E., Shakeshaft, A., Ritter, A., et al.[2022]

The MOSES method, which incorporates the timing and severity of adverse events, was found to be more accurate than the traditional CTCAE system in predicting the impact of symptoms on quality of life in cervical cancer patients undergoing radiotherapy, with a study involving 300 patients.

In comparing two radiotherapy techniques, 3DCRT showed a higher cumulative MOSES score than IMRT, indicating potentially greater late toxicity, despite no significant difference in overall gastrointestinal toxicity grades between the two methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Months and Severity Score (MOSES) in a Phase III trial (PARCER): A new comprehensive method for reporting adverse events in oncology clinical trials. Ranjan, N., Chopra, S., Mangaj, A., et al.[2022]

Personalized drinking feedback interventions (PFIs) are effective in reducing harmful alcohol misuse among college students, based on a comprehensive review of 41 studies.

Interventions that included components like decisional balance, practical costs, and risk-limiting strategies showed significantly larger effects, highlighting the importance of these elements in developing effective feedback-based interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized feedback interventions for college alcohol misuse: an update of Walters & Neighbors (2005). Miller, MB., Leffingwell, T., Claborn, K., et al.[2022]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

In a study involving 121 participants from a community substance use disorder clinic, personalized feedback interventions did not show any significant benefits in reducing alcohol consumption compared to standard pre-treatment assessment procedures.

The results indicated that feedback-based brief interventions were ineffective in improving outcomes such as drinking frequency, intensity, or motivation for treatment among individuals with substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Feedback-Based Brief Intervention to Reduce Alcohol Use in Community Substance Use Disorders. Worden, BL., McCrady, BS.[2021]

In a study involving 118 clinicians across 20 outpatient substance abuse treatment clinics, a semiautomated patient feedback system was tested over 12 weeks, but it did not show any significant impact on reducing drug and alcohol use among over 1,500 patients.

The intervention also failed to improve secondary outcomes related to therapeutic alliance and clinician job satisfaction, suggesting that the feedback system may need alternative approaches to enhance clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled study of a web-based performance improvement system for substance abuse treatment providers. Crits-Christoph, P., Ring-Kurtz, S., McClure, B., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-substance-related-disorders-4-2025-9051a

Personalized Feedback for Substance Use Disorder ... Research shows that personalized feedback interventions are effective in reducing alcohol consumption and related problems, particularly among college students.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4392758/

Efficacy of Web-Based Personalized Normative Feedback Results from hierarchical generalized linear models provided modest effects on weekly drinking and alcohol-related problems but not on heavy episodic drinking.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0955395925000696

The relationship between patient-centred care for ... The findings from this review suggest largely positive associations between these PCC components and the outcomes of generalist and specialist SUD services.

4. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1229262/full

The effectiveness of the community reinforcement ... The present study investigated the effectiveness of the Community Reinforcement Approach (CRA) in the context of quality of life among drug addicts.

5. nature.com nature.com/articles/s41598-025-06384-0

Trait-based recovery enhances engagement and reduces ... This study explicitly evaluates the effectiveness of the Trait-Based Model of Recovery in enhancing measurable personality traits—such as ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3682930/

Attendance and Substance Use Outcomes for the Seeking ... This study uses data from the largest effectiveness trial to date on treatment of co-occurring posttraumatic stress and substance use disorders.

7. researchgate.net researchgate.net/publication/392866578_Substance_Use_Disorder_Treatment_Outcomes_Methodological_Overview_of_Metrics_and_Criteria

(PDF) Substance Use Disorder Treatment Outcomes This review aims to parse such heterogeneity by analysing the operational definitions of variables used to derive metrics and outcome criteria, ...

8. library.samhsa.gov library.samhsa.gov/sites/default/files/tip-35-pep19-02-01-003.pdf

SAMHSA TIP 35: Enhancing Motivation for Change Motivation for change is a key component in addressing substance misuse. This Treatment Improvement. Protocol (TIP) reflects a fundamental rethinking of the ...