Addiction Risk Feedback Program for Substance Abuse

(ARFP Trial)

Overseen By Emily Balcke

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Under 18, Over 25, others

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

Compensation: Varies

Number of Visits: 5

660 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to test whether completion of a new personalized feedback program is associated with reductions in risky substance use among emerging adults (18-25 years of age).

Do I have to stop taking my current medications for the trial?

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

What data supports the effectiveness of the Addiction Risk Feedback Program treatment for substance abuse?

Research shows that personalized feedback interventions can effectively reduce alcohol consumption and related problems, suggesting that similar feedback-based approaches, like the Addiction Risk Feedback Program, may help in substance abuse treatment. Additionally, systematic client feedback, as seen in the Partners for Change Outcome Management System, has been shown to improve outcomes in psychotherapy, indicating potential benefits for substance abuse treatment. ^{1 2 3 4 5}

Is the Addiction Risk Feedback Program safe for humans?

The Personalized Feedback Program, which is similar to the Addiction Risk Feedback Program, has been tested with college students and no safety concerns were reported in the studies. Participants generally enjoyed the program and intended to use more campus resources, suggesting it is safe for use in humans. ^{6 7 8 9 10}

How is the Addiction Risk Feedback Program treatment different from other treatments for substance abuse?

The Addiction Risk Feedback Program is unique because it provides personalized feedback based on an individual's genetically influenced risk factors, such as sensation seeking and impulsivity, to help them understand their specific risk profile and make informed decisions about substance use. This approach shifts the focus from current substance use to underlying risk factors, which is different from standard treatments that typically address only current behaviors. ^{2 6 7 9 10}

Research Team

Danielle Dick, PhD

Principal Investigator

Rutgers Robert Wood Johnson Medical School

Eligibility Criteria

This trial is for young adults aged 18-25 living in the U.S. who speak English and are willing to give informed consent. It's not open to those outside this age range, non-U.S. residents, or anyone unwilling to agree formally to participate.

Exclusion Criteria

I am under 18 years old.

Participants residing outside of the United States

Participants who do not provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline Assessment

Participants complete a behavioral/environmental risk survey and provide saliva samples for genetic risk assessment

1 week

1 visit (in-person or virtual)

Intervention

Participants receive personalized risk estimates and engage in one of the intervention conditions: psychoeducation, online CBT modules, or genetic counseling

8 weeks

1 visit (in-person or virtual) for risk estimate delivery

Follow-up

Participants are monitored for changes in substance use and related outcomes

3 months

3 visits (virtual) at 1 month and 3 months post-intervention

Post-Study Access

Participants in the control condition receive their personalized risk estimates and all participants are offered access to other intervention contents

1 week

Treatment Details

Interventions

• Addiction Risk Feedback Program

Trial Overview The study is examining a new personalized feedback program designed to help reduce risky substance use among emerging adults. Participants will complete this intervention program aimed at lowering their chances of developing substance use disorders.

Participant Groups

Group I: Waitlist Control - Psychoeducation Only Experimental Treatment 1 Intervention

Participants in this condition will not receive their personalized risk estimates until the end of the study. They will receive psychoeducation about ways to reduce substance use and associated harm at the time that the active conditions receive their estimates and associated follow-up content.

Group II: Risk estimates + Genetic Counselor Active Control 1 Intervention

Participants in this condition will complete the prevention program in which individuals receive their personalized risk estimates, followed by a follow-up appointment with a genetic counselor.

Group III: Risk estimates + Psychoeducation Active Control 1 Intervention

Participants in this condition will complete the prevention program in which individuals receive their personalized risk estimates, followed by psychoeducation about ways to reduce substance use and associated harm.

Group IV: Risk estimates + Online CBT Modules Active Control 1 Intervention

Participants in this condition will complete the prevention program in which individuals receive their personalized risk estimates, followed by on-line cognitive behavioral therapy (CBT)-based modules to assist with controlling substance use.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

This project aims to involve substance misuse patients in their treatment by using patient-generated outcome measures (PGOMs), which allow patients to suggest topics for evaluating their treatment, potentially leading to more personalized care.

The research will assess the reliability and sensitivity of PGOMs compared to standard measures, with the expectation that PGOMs will provide valuable insights into patients' personal concerns and motivations, ultimately enhancing treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the patient involvement in outcomes: a study protocol of personalised outcome measurement in the treatment of substance misuse. Alves, PC., Sales, CM., Ashworth, M.[2021]

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]

Systematic client feedback, such as the Partners for Change Outcome Management System (PCOMS), can improve psychotherapy outcomes by addressing issues like client dropouts and varying therapist effectiveness, as supported by randomized clinical trials.

PCOMS not only provides psychometric measures but also emphasizes the importance of client perspectives in therapy, potentially shifting the focus from a purely medical model to a more relational and scientific approach in psychotherapy practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Partners for Change Outcome Management System (PCOMS) revisiting the client's frame of reference. Duncan, BL., Reese, RJ.[2019]

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]

This systematic review analyzed 10 studies on the impact of routine outcome monitoring (ROM) feedback in alcohol and other drug (AOD) treatment, finding that while feedback may improve treatment retention and other outcomes, only one study showed significant reductions in substance use among clients who were not progressing well.

The review highlights the need for more robust randomized trials to better understand the efficacy of feedback in AOD treatment, as the current studies varied widely in methods and outcomes, limiting definitive conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on the effect of routine outcome monitoring and feedback on client outcomes in alcohol and other drug treatment. Cordony, I., Mills, L., Mammen, K., et al.[2023]

The study introduces an online Personalized Feedback Program (PFP) aimed at college students, focusing on their genetically influenced risk factors for substance use rather than just their current usage, which could enhance prevention efforts.

Using data from over 12,000 students, the program identifies key risk factors like Sensation Seeking and Impulsivity, and aims to provide tailored recommendations to help students better manage their substance use risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetically influenced externalizing and internalizing risk pathways as novel prevention targets. Dick, DM., Saunders, T., Balcke, E., et al.[2023]

An online Personalized Feedback Program (PFP) was developed for college students to address genetically-influenced risk factors for substance use, and 81% of participants reported enjoying the program.

After completing the PFP, 39% of students who drank intended to reduce their alcohol consumption, and 41% intended to decrease their frequency of getting drunk, indicating a higher intention to change compared to previous studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Results from a New College Substance Use Prevention Program Targeting Externalizing and Internalizing Traits. Choi, M., Driver, MN., Balcke, E., et al.[2023]

A study involving 5476 Brazilian college students found that the components of personalized normative feedback (PNF) did not significantly reduce alcohol use or its consequences compared to the full intervention, with some evidence suggesting adverse effects, particularly among less motivated participants.

The normative feedback only (NFO) and consequences feedback only (CFO) components showed some short-term benefits in reducing alcohol use and frequency, but they also led to an increase in the number of typical drinks consumed over time, indicating a complex relationship between feedback and drinking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Components evaluation of a web-based personalized normative feedback intervention for alcohol use among college students: a pragmatic randomized controlled trial with a dismantling design. Bedendo, A., McCambridge, J., Gaume, J., et al.[2021]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Enhancing the patient involvement in outcomes: a study protocol of personalised outcome measurement in the treatment of substance misuse. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Who Opts In to Alcohol Feedback and How Does That Impact Behavior? A Pilot Trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The Partners for Change Outcome Management System (PCOMS) revisiting the client's frame of reference. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled study of a web-based performance improvement system for substance abuse treatment providers. [2021]

5. Australia pubmed.ncbi.nlm.nih.gov

A systematic review on the effect of routine outcome monitoring and feedback on client outcomes in alcohol and other drug treatment. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Genetically influenced externalizing and internalizing risk pathways as novel prevention targets. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Initial Results from a New College Substance Use Prevention Program Targeting Externalizing and Internalizing Traits. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Components evaluation of a web-based personalized normative feedback intervention for alcohol use among college students: a pragmatic randomized controlled trial with a dismantling design. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Personalized feedback interventions for college alcohol misuse: an update of Walters & Neighbors (2005). [2022]

10. United States pubmed.ncbi.nlm.nih.gov

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