NCT07219394

Brief Summary

Low-income individuals have limited access to evidence-based interventions for mental health. Peer recovery specialists, individuals in recovery from mental health and/or substance use problems, have the potential to increase access to evidence-based interventions for individuals from low-resource communities, particularly when trained and supervised in models that are acceptable and feasible in these communities. This study will examine the effectiveness and implementation potential of a peer-delivered evidence-based intervention (Behavioral Activation) among individuals receiving services from a community-based treatment setting providing integrated physical and behavioral healthcare.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
31mo left

Started May 2026

Typical duration for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress5%
May 2026Jan 2029

First Submitted

Initial submission to the registry

July 21, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 21, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2029

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

July 21, 2025

Last Update Submit

April 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Hamilton Depression Rating Scale

    The Hamilton Depression Rating Scale (HAM-D) is a structured interview regarding patients' symptoms of depression and functional impairment. The HAM-D will be administered by research assistants under the supervision of the MPI (Felton) at baseline, post-intervention, 6- and 12-month follow-up. The measure is widely used in depression and substance use treatment studies and has excellent psychometric properties. Nine items are scored 0-4 and 8 items are scored 0-2, with higher scores reflecting greater levels of depressive symptoms. A total score will be calculated by summing each other items. Summed total scores can range from 0-52, with higher values reflecting greater depression.

    Baseline, post-intervention (approximately 3 months after baseline), 6- and 12-month follow-up

Secondary Outcomes (2)

  • Change in Patient Health Questionnaire-9

    Baseline, post-intervention (approximately 3 months after baseline), 6- and 12-month follow-up

  • Change in Short Inventory of Problems

    Baseline, post-intervention (approximately 3 months after baseline), 6- and 12-month follow-up

Study Arms (2)

Behavioral Activation

EXPERIMENTAL

Peer Activate is an adapted behavioral activation (BA) intervention, developed for delivery by peer recovery specialists to reduce rates of depressive symptoms and substance use. BA focuses on increasing positive reinforcement through engaging in adaptive, valued behaviors. BA has been found to be effective in improving substance use outcomes and decreasing depressive symptoms among low-income individuals with SUD. Peer Activate includes 6 weekly sessions with up to 6 additional booster sessions.

Behavioral: Peer Activate

Enhanced Treatment as Usual

ACTIVE COMPARATOR

Enhanced treatment as usual (ETAU) involves peer-delivered non-directive support, including facilitated linkages to care and non evidence-based intervention approaches typically used by peer recovery specialists.

Behavioral: Peer-delivered non-specific services

Interventions

Peer ActivateBEHAVIORAL

Peer Activate is an adapted behavioral activation (BA) intervention, developed for delivery by peer recovery specialists to reduce rates of depressive symptoms and substance use. BA focuses on increasing positive reinforcement through engaging in adaptive, valued behaviors. BA has been found to be effective in improving substance use outcomes and decreasing depressive symptoms among low-income individuals with SUD. Peer Activate includes 6 weekly sessions with up to 6 additional booster sessions.

Behavioral Activation

Peers will deliver non-specific peer services, including linkage to care, general support, and facilitated referrals to external providers as needed.

Enhanced Treatment as Usual

Eligibility Criteria

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

You may qualify if:

  • Age 18 years old or older
  • Report clinically-significant symptoms of depression, as indexed by a score of 8+ on the PHQ-9.

You may not qualify if:

  • Active, under treated psychotic symptoms or mania that would interfere with participation in study procedures
  • Inability to provide informed consent and/or complete procedures in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Detroit Recovery Project

Detroit, Michigan, 48208, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, MajorSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersChemically-Induced Disorders

Central Study Contacts

Julia Felton, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 21, 2025

First Posted

October 21, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

January 15, 2029

Study Completion (Estimated)

January 15, 2029

Last Updated

April 17, 2026

Record last verified: 2026-04

Locations