NCT06803810

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2025

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

January 27, 2025

Last Update Submit

February 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reduction in depressive symptoms

    Reduce depression symptoms as measured by the PHQ-9

    12 weeks

Study Arms (2)

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.

Behavioral: P2P Intervention

Interventions

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.

P2P Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prisma Health

Greenville, South Carolina, 29605, United States

Location

Study Officials

  • Alain Litwin

    Prisma Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2025

First Posted

January 31, 2025

Study Start

November 11, 2024

Primary Completion

December 29, 2025

Study Completion

December 29, 2025

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations