Peer-to-Peer Intervention for Substance Use Disorders

(P2P Trial)

Overseen By Abby Blackwell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Prisma Health-Upstate

Must be taking: MOUD

Disqualifiers: Severe cognitive, medical, psychiatric disability, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a peer-to-peer support program (P2P Intervention) to assist people in rural areas dealing with both mental health issues and substance use disorders. The focus is on reducing anxiety and depression, which can hinder adherence to recovery treatment. Participants receive support from a peer specialist, who guides them through problem-solving therapy and connects them to helpful resources. This trial may suit individuals diagnosed with opioid use disorder (OUD) who have participated in a recovery program for at least three months and are experiencing moderate to severe depression. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance support systems for those in recovery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since participants must be receiving medication for opioid use disorder (MOUD) for at least 3 months, it seems you will need to continue that treatment.

What prior data suggests that this intervention is safe for participants?

Research has shown that peer-to-peer (P2P) programs are generally safe for individuals dealing with substance use issues. Studies have found these programs to be well-received. For instance, digital therapy programs, which sometimes include peer-to-peer support, have demonstrated safety. Reports of harmful side effects or negative events from these programs are rare.

Peer support programs also correlate with positive effects on mental health. Individuals in recovery often experience improvements comparable to or better than those from traditional treatments. This suggests that peer-to-peer programs might offer a safe and effective way to address mental health issues, such as anxiety and depression, in people with substance use problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Peer-to-Peer (P2P) Intervention for Substance Use Disorders because it takes a fresh approach to treatment by incorporating Certified Peer Support Specialists (CPSS) into the therapy process. Unlike standard treatments that may rely solely on professional healthcare providers, this intervention leverages the unique experiences and insights of peers who have successfully managed their own substance use challenges. This peer-led component could enhance empathy, relatability, and support, potentially making therapy more engaging and effective for participants. Additionally, the P2P Intervention includes regular check-ins and structured sessions within a 12-week period, providing consistent support and monitoring that may boost recovery outcomes.

What evidence suggests that the P2P Intervention might be an effective treatment for substance use disorders?

Research has shown that programs like the P2P program, one of the treatments in this trial, where people help each other, hold promise for treating substance use disorders. Studies have found that peer support can reduce mental health issues such as anxiety and depression, which often hinder recovery. The Friendship Bench approach, part of this program, includes therapy sessions focused on problem-solving, which have been linked to improved mental health and social support. Early results from peer-led programs suggest they can increase involvement in recovery activities and facilitate access to care. Overall, the P2P program aims to connect patients with resources and support, potentially leading to better long-term recovery outcomes. ^{1 2 6 7 8}

Who Is on the Research Team?

Alain Litwin

Principal Investigator

Prisma Health

Are You a Good Fit for This Trial?

This trial is for individuals with substance use disorders who are facing mental health challenges like anxiety and depression, particularly in rural areas. Participants should be dealing with co-occurring mental health and substance abuse issues, and will be evaluated for opioid use disorder, social factors affecting health, and infectious diseases.

Inclusion Criteria

I have moderate to severe depression, possibly with anxiety.

Diagnosis of OUD via Diagnostic Statistical Manual (DSM)-V Text Revision (TR)

I have been in the Mobile Recovery Program for at least 3 months.

Exclusion Criteria

Current suicidal ideation based on the Patient Health Questionnaire-9

Severe cognitive, medical, or psychiatric disability that could impair ability to perform study-related activities as determined by the MRP clinician or principal investigator

Unable to read and comprehend the consent materials and other study materials

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a modified version of the Friendship Bench intervention, involving six weekly 45-minute problem-solving therapy sessions and optional peer support sessions

12 weeks

6 CPSS-led therapy sessions, additional peer support sessions

Follow-up

Participants are monitored for reduction in depressive symptoms and other outcomes

12 weeks

Baseline, week 6, and week 12 visits

What Are the Treatments Tested in This Trial?

Interventions

• P2P Intervention

Trial Overview The study tests a peer-to-peer intervention where certified support specialists provide six weeks of problem-solving therapy sessions plus optional ongoing peer support. The goal is to connect patients to long-term mental health resources and help them overcome barriers to recovery.

How Is the Trial Designed?

Group I: P2P Intervention Experimental Treatment 1 Intervention

This group will complete the same study visits as the standard care group with an additional week 3 visit and 6 CPSS-led therapy intervention sessions. These CPSS led sessions will be completed by the end of the 12week study period. At each study visit you will complete questionnaires.

Group II: Standard of Care Active Control 1 Intervention

This group will complete a baseline, week 6, and week 12 study visit. Participants will complete research visits (in-person or virtually) at which time they will complete a series of questionnaires.

Who Is Running the Clinical Trial?

Prisma Health-Upstate

Lead Sponsor

Trials

91

Recruited

47,500+

South Carolina Center for Rural and Primary Healthcare

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

Peer-delivered services for substance use in low- and middle-income countries (LMICs) show potential in reducing risk behaviors and increasing knowledge about infectious diseases, based on a systematic review of 34 studies across four continents.

Despite some positive impacts, many studies indicated no significant differences in outcomes compared to control groups, highlighting the need for further research to better understand the effectiveness of these interventions in LMICs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-delivered services for substance use in low- and middle-income countries: A systematic review. Satinsky, EN., Kleinman, MB., Tralka, HM., et al.[2021]

Internet-based treatment for substance use disorders, such as alcohol and cannabis problems, offers unique advantages and challenges compared to face-to-face therapy, as highlighted by focus group interviews with 12 therapists.

Key differences include communication styles, the impact of anonymity, and the use of time, which all affect the therapeutic alliance and require therapists to adapt their skills for effective online treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sort of a nice distance: a qualitative study of the experiences of therapists working with internet-based treatment of problematic substance use. Ekström, V., Johansson, M.[2020]

Peer recovery support services (PRSS) show promise in improving outcomes for individuals with substance use disorder (SUD), including reduced substance use, lower relapse rates, and increased treatment satisfaction, based on a systematic review of various studies.

However, the existing research has significant methodological limitations, such as inconsistent definitions of peer roles and a lack of appropriate comparison groups, highlighting the need for more rigorous studies to better understand the efficacy and implementation of PRSS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lived Experience in New Models of Care for Substance Use Disorder: A Systematic Review of Peer Recovery Support Services and Recovery Coaching. Eddie, D., Hoffman, L., Vilsaint, C., et al.[2023]

A peer-enhanced behavioral treatment called Peer-CRA was tested with 35 emerging adults, showing that both clients and their trained peers significantly increased their days of abstinence and reduced binge drinking over six months.

The treatment was delivered effectively, with high retention rates, suggesting that involving peers in substance use disorder treatment could be a promising approach that warrants further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six Month Outcomes of a Peer-Enhanced Community Reinforcement Approach for Emerging Adults with Substance Misuse: A Preliminary Study. Smith, DC., Davis, JP., Ureche, DJ., et al.[2019]

Web-based interventions for substance use disorders are currently under-researched, with no large randomized controlled trials available, indicating a significant gap in the evidence base for their effectiveness.

Despite the limited and flawed literature, there is a strong demand for internet-based interventions, suggesting they could be as effective as traditional therapy for less severe cases of substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based interventions for substance use disorders: a qualitative review. Copeland, J., Martin, G.[2006]

A randomized clinical trial involving 85 participants evaluated the use of a Web-based videoconferencing platform for substance abuse counseling, showing that it is a feasible and acceptable alternative to in-person sessions.

Both Web-based and in-person counseling resulted in similar attendance rates and treatment satisfaction, indicating that online counseling can effectively extend access to treatment for individuals with reliable internet access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of Web-based videoconferencing for substance abuse counseling. King, VL., Brooner, RK., Peirce, JM., et al.[2021]

The study demonstrated the feasibility of a semiautomated Patient Feedback system in outpatient substance abuse treatment clinics, achieving a 75.5% collection rate of patient data across 39 clinicians and 6 supervisors over a year-long study.

Clinicians generally received positive ratings for treatment satisfaction and therapeutic alliance, but one clinic showed significant improvement in self-reported drug use after implementing the system, indicating potential benefits of real-time patient feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study of a web-based performance improvement system for substance abuse treatment providers. Forman, R., Crits-Christoph, P., Kaynak, O., et al.[2019]

A digital therapeutic (DT) significantly increased abstinence rates among patients with substance use disorders (40.3% in the DT group vs. 17.6% in the treatment-as-usual group) over a 12-week period, indicating its efficacy in reducing substance use.

The DT also improved retention in treatment (76.2% vs. 63.2%), and importantly, there were no significant differences in adverse event rates between the DT and traditional treatment groups, suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a digital therapeutic for substance use disorder: Secondary analysis of data from a NIDA clinical trials network study. Maricich, YA., Nunes, EV., Campbell, ANC., et al.[2022]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

A study of 66 active cocaine users found that most participants reported regular Internet use, indicating that this population has similar rates of Internet access as the general public.

Younger individuals and those who use other drugs were more likely to be Internet users, suggesting that web-based interventions could be effectively targeted to reach cocaine users for treatment and research purposes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profile of internet access in active cocaine users. Strickland, JC., Wagner, FP., Stoops, WW., et al.[2018]

In a pilot study involving 80 adults with recent non-fatal opioid overdoses, trained peer interventionists successfully delivered a Peer Recovery Support Services (PRSS) intervention, achieving a treatment enrollment success rate between 16% and 60%.

The interventionists reported no negative effects from their role, indicating that peer-led interventions can be implemented safely and effectively with limited training, although further research is needed to understand the factors influencing their varying success rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility and safety of training patients in opioid treatment to serve as peer recovery support service interventionists. Kropp, F., Wilder, C., Theobald, J., et al.[2022]

Citations

1. withpower.com withpower.com/trial/peer-to-peer-intervention-for-substance-use-disorders-48dac

Peer-to-Peer Intervention for Substance Use Disorders This study provides substance use and mental health peer support services to address behavioral health disparities in rural areas.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06803810

Peer to Peer (P2P): Mental Health Interventions with ... Specifically, the project aims to address persistent mental health symptoms, such as anxiety and depression, that become barriers to care for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12215800/

A cluster-randomized stepped-wedge trial Brief interventions can be more effective when combined with medications (e.g., buprenorphine, naltrexone), which can reduce acute cravings and ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/add.16528

Effect of a peer‐led prevention program (P2P) on smoking ... The aim of this work was to measure the impact of P2P (ie peer-to-peer), a peer-led smoking prevention intervention, on daily smoking prevalence of adolescents ...

5. preprints.org preprints.org/manuscript/202203.0279/v1/download

The Pathways to Participation (P2P) program The findings indicate the P2P program may enable consumers to achieve positive activity and participation outcomes as part of their personal.

6. mdpi.com mdpi.com/1660-4601/19/10/6088

The Pathways to Participation (P2P) Program: A Pilot ... A total of five key outcomes were identified for investigation in this study: consumer identified needs, time use, self-rated recovery, psychosocial health, and ...

7. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ps.201700101

The Michigan Peer-to-Peer Depression Awareness Program In this report, we describe the P2P program and provide outcome data from the 10 high schools that were involved during the 2015–2016 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8524681/

Voices of Hope: Substance Use Peer Support in a System ... Peer support has been empirically associated with positive behavioral health outcomes for individuals in recovery that are equal to or greater ...