Major Depressive DisorderNCT07219394
Peer-Delivered Behavioral Activation in a CCBHC
A study testing Peer Activate and Peer-delivered non-specific services in people with Major Depressive Disorder and Substance Use Disorders, run by Wayne State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Substance Use Disorders
- What is being tested?
- Peer Activate and Peer-delivered non-specific services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 15 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 years old or older
- Report clinically-significant symptoms of depression, as indexed by a score of 8+ on the PHQ-9.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Detroit Recovery Project
Detroit, Michigan, 48208
Andre Johnson, PhD
About this study
Official title: Hybrid Effectiveness-Implementation Trial to Evaluate a Scalable, Peer-Delivered Intervention for Depression Among People With Substance Use Disorder in a Certified Community Behavioral Health Clinic
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.
- Conditions
- Major Depressive Disorder, Substance Use Disorders
- Being tested
- Peer Activate, Peer-delivered non-specific services
- Medical subject headings
- Depressive Disorder, Major, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer ActivateBehavioural
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.
Peer-delivered non-specific servicesBehavioural
Peers will deliver non-specific peer services, including linkage to care, general support, and facilitated referrals to external providers as needed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Peer-delivered non-specific services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post-intervention (approximately 3 months after baseline), 6- and 12-month follow-up
Secondary outcomes (2)
Change in Patient Health Questionnaire-9
The Patient Health Questionnaire-9 (PHQ-9) is a self-report measure of depressive symptoms. Participants will complete the PHQ-9 at baseline, post-intervention, 6- and 12-month follow-up. The measure is valid and reliable in low-resource community settings. The measure includes nine items which are scored from 0-3, with 3 reflecting more severe levels of each depressive symptom. A total score is created by summing items with a possible range from 0-27 (with higher scores reflecting greater depressive symptoms).
Measured: Baseline, post-intervention (approximately 3 months after baseline), 6- and 12-month follow-up
Change in Short Inventory of Problems
The Short Inventory of Problems is a self-report measure of problems related to substance use. Participants will complete the SIP at baseline, post-intervention, 6- and 12-month follow-up. The measure is valid and reliable and has been used by the investigator team in numerous studies among low-income populations. The measure includes 17 items, each ranked from 0-3 with higher scores reflecting greater problems related to alcohol and substance use. A total score is created by summing each item and can range from 0-51 with higher values reflecting more substance-related problems.
Measured: Baseline, post-intervention (approximately 3 months after baseline), 6- and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start1 May 2026 (estimated)
- Primary completion15 Jan 2029 (estimated)
- Study completion15 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, College Park, Detroit Recovery Project INC
- Responsible party
- Principal investigator, Julia Felton, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219394
- Sponsor's protocol ID
- BARCT: 25-02-7552
- Status last verified
- Apr 2026
- First submitted
- 21 Jul 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Effectiveness-Implementation Trial to Evaluate a Scalable, Peer-Delivered Intervention for Depression Among People With Substance Use Disorder in a Certified Community Behavioral Health Clinic
- ClinicalTrials.gov ID
- NCT07219394
- Acronym / sponsor ID
- BARCT: 25-02-7552
- Conditions
- Major Depressive Disorder, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- University of Maryland, College Park, Detroit Recovery Project INC
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 15 Jan 2029 (estimated)
- Study completion
- 15 Jan 2029 (estimated)
- First posted
- 21 Oct 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation | Experimental | Behavioral: Peer ActivatePeer 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. |
| Enhanced Treatment as Usual | Active comparator | Behavioral: Peer-delivered non-specific servicesEnhanced 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years old or older
- Report clinically-significant symptoms of depression, as indexed by a score of 8+ on the PHQ-9.
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Peer ActivatePeer 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. | Behavioural | Behavioral Activation |
| Peer-delivered non-specific servicesPeers will deliver non-specific peer services, including linkage to care, general support, and facilitated referrals to external providers as needed. | Behavioural | Enhanced Treatment as Usual |
Primary outcome
Change in Hamilton Depression Rating Scale
Time frame: Baseline, post-intervention (approximately 3 months after baseline), 6- and 12-month follow-up
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.
2 secondary outcomes
Change in Patient Health Questionnaire-9
Time frame: Baseline, post-intervention (approximately 3 months after baseline), 6- and 12-month follow-up
Change in Short Inventory of Problems
Time frame: Baseline, post-intervention (approximately 3 months after baseline), 6- and 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Activate and Peer-delivered non-specific services in people with Major Depressive Disorder and Substance Use Disorders, run by Wayne State University 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 17 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Felton, PhD (7049957832, hv8914@wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale (time frame: Baseline, post-intervention (approximately 3 months after baseline), 6- and 12-month follow-up). 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 17 Apr 2026.