- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06803810
Peer to Peer (P2P): Mental Health Interventions With Persons With Substance Use Disorders (P2P)
February 4, 2026 updated by: Prisma Health-Upstate
This study provides substance use and mental health peer support services to address behavioral health disparities in rural areas.
Specifically, the project aims to address persistent mental health symptoms, such as anxiety and depression, that become barriers to care for patients working towards long-term recovery from co-occurring mental health and substance use disorders.
Participants will be assessed and evaluated for opioid use disorder (OUD), social determinants of health (SDoH), and infectious diseases by a nurse practitioner and a social worker.
A certified peer support specialist (CPSS) will provide additional support, connecting patients to sustainable mental health resources and implementing a modified version of the Friendship Bench intervention, which involves six weekly 45-minute problem-solving therapy sessions with the option to participate in six or more peer support sessions.
The CPSS will follow the patient for up to 12 weeks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
Greenville, South Carolina, United States, 29605
- Prisma Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of OUD via Diagnostic Statistical Manual (DSM)-V Text Revision (TR)
- Receiving MOUD through the Mobile Recovery Program for at least 3 months
- Age 18 or older
- Moderate to Severe Depression with or without co-occurring anxiety as determined by PHQ-9 conducted during the most recent MRP clinical visit
Exclusion Criteria:
- 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/speak English
- Unable to read and comprehend the consent materials and other study materials
- Current suicidal ideation based on the Patient Health Questionnaire-9
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard of Care
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.
|
|
|
Experimental: P2P 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in depressive symptoms
Time Frame: 12 weeks
|
Reduce depression symptoms as measured by the PHQ-9
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alain Litwin, Prisma Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 11, 2024
Primary Completion (Actual)
December 29, 2025
Study Completion (Actual)
December 29, 2025
Study Registration Dates
First Submitted
January 27, 2025
First Submitted That Met QC Criteria
January 27, 2025
First Posted (Actual)
January 31, 2025
Study Record Updates
Last Update Posted (Actual)
February 6, 2026
Last Update Submitted That Met QC Criteria
February 4, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2220242
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.