Standard of CareP2PNCT06803810
Peer to Peer (P2P): Mental Health Interventions With Persons With Substance Use Disorders
A study testing P2P Intervention in people with Standard of Care and P2P Intervention, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Standard of Care, P2P Intervention
- What is being tested?
- P2P Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2024to 29 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Standard of Care, P2P Intervention
- Being tested
- P2P Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P2P InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No 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. |
| P2P Intervention | Experimental | 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. Receives: Behavioral: P2P Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in depressive symptoms
Reduce depression symptoms as measured by the PHQ-9
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start11 Nov 2024
- Primary completion29 Dec 2025
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Standard of CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- South Carolina Center for Rural and Primary Healthcare
- Responsible party
- Sponsor
- Investigators
- Alain Litwin, Principal investigator, Prisma Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803810
- Sponsor's protocol ID
- 2220242
- Acronym
- P2P
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer to Peer (P2P): Mental Health Interventions With Persons With Substance Use Disorders
- ClinicalTrials.gov ID
- NCT06803810
- Acronym / sponsor ID
- P2P / 2220242
- Conditions
- Standard of Care, P2P Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- South Carolina Center for Rural and Primary Healthcare
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 29 Dec 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No 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. |
| P2P Intervention | Experimental | Behavioral: P2P InterventionThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P2P InterventionThis 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. | Behavioural | P2P Intervention |
Primary outcome
Reduction in depressive symptoms
Time frame: 12 weeks
Reduce depression symptoms as measured by the PHQ-9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Litwin principal investigator
Prisma Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P2P Intervention in people with Standard of Care and P2P Intervention, run by Prisma Health-Upstate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in depressive symptoms (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.