DepressionRECOUP-NYNCT04913766
REstoring Mental Health Through COmmUnity-based Psychological Services in New York City
A study testing Problem Management Plus and Services as Usual in people with Depression and Anxiety, run by George Washington University at 1 site in United States.
Trial summary
The goal is to improve mental health. The study will evaluate the impact of community-based mental health services. Successful completion of this study will contribute to the National Institute of Mental Health Strategic Plan employing implementation science to maximize the public health impact of research for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Psychological Distress
- What is being tested?
- Problem Management Plus and Services as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,206 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2022to 9 Feb 2026
- 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
- Persons with Patient Health Questionnaire 4 scores equal to or above 3
- Functional impairment associated with psychological distress
Who cannot join
- Acute suicide risk
- Patient Health Questionnaire 4 score below 3
- No functional impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REstoring Mental Health Through COmmUnity-based Psychological (RECOUP-NY)
The goal is to improve mental health. The study will evaluate the impact of community-based mental health services. Successful completion of this study will contribute to the National Institute of Mental Health Strategic Plan employing implementation science to maximize the public health impact of research for effectiveness and reach of mental health services in the United States.
Read the detailed description
There is a need for delivery of psychological interventions by non-specialists when specialists are unable to meet the service demand. In the United States, training staff at community-based organizations to deliver psychological support has been highlighted as a way to increase availability of mental health services and increase access to mental health care, particularly for underserved populations. This study employs a mental health task-sharing model by partnering with community based organizations in New York City to train community based organizations staff without professional mental health training to deliver mental health services. This study examine the impact of community based organizations staff delivering mental health services to reduce mental health problems. This study is a cluster randomized control trial in New York City comparing Services as Usual arm and delivery of mental health services with Problem Management Plus (Intervention arm) among participating community based organizations. The target condition will be general psychological distress. This study will evaluate mental health outcomes populations served by community based organizations integrating Problem Management Plus into their other activities compared to community based organizations delivering services as usual. This study will evaluate implementation science outcomes to inform policy recommendations for of community-based delivery of psychological interventions. Successful completion of these aims will contribute to the 2020 National Institute of Mental Health Strategic Plan. Specifically, a) employing implementation science to maximize the public health impact of research for improving effectiveness and reach of mental health services, b) strengthening research-practice partnerships to expedite adoption, sustained implementation, and continuous improvement of evidence-based mental health services, and c) developing innovative service delivery models to dramatically improve outcomes of mental health services.
- Conditions
- Depression, Anxiety, Psychological Distress, PTSD
- Being tested
- Problem Management Plus, Services as Usual
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Management PlusBehavioural
Five session psychological intervention focusing on problem management skills.
Services as UsualBehavioural
Mental health services provided by a mental health specialists according to their standard practices of care
| Study group | Role | What they receive |
|---|---|---|
| Services as usual | Active comparator | Persons screening positive for depression will be referred from community-based organizations. The referrals will be made to mental health specialists who will provide care based on their standard of care. Receives: Behavioral: Services as Usual |
| Problem Management Plus | Experimental | Persons screening positive for depression will be offered Problem Management Plus delivered by community based organization staff. Receives: Behavioral: Problem Management Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Outcome Profiles Questionnaire; Unabbreviated scale title "Psychological Outcome Profiles questionnaire"
4-item self-report questionnaire that is a personalized measure of psychological distress.
Measured: 20 weeks after baseline assessment
Secondary outcomes (3)
Patient Health Questionnaire 9; Unabbreviated scale title "Patient Health Questionnaire 9"
9-item self-report scale to assess symptoms of depression, minimum value=0, maximum value=27, higher scores mean greater depression symptoms
Measured: 20 weeks after baseline assessment
Generalized Anxiety Disorder 7; Unabbreviated scale title "Generalized Anxiety Disorder 7"
7-item self-report scale to assess symptoms of depression, minimum value=0, maximum value=21, greater scores mean more anxiety symptoms
Measured: 20 weeks after baseline assessment
Posttraumatic Stress Disorder Checklist 5; Unabbreviated scale title "Posttraumatic Stress Disorder Checklist 5"
8-item self-report scale for symptoms of posttraumatic stress disorder, minimum value=0, maximum value=24, greater scores mean more posttraumatic stress symptoms
Measured: 20 weeks after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start25 Oct 2022
- Primary completion9 Feb 2026
- Study completion9 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- 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
- Model description
- Cluster randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,206 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- The New School, Duke University, Human Sciences Research Council
- Responsible party
- Principal investigator, Brandon A Kohrt, MD, PhD, George Washington University
- Investigators
- Brandon Kohrt, MD, PhD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913766
- Sponsor's protocol ID
- R01MH127767
- Acronym
- RECOUP-NY
- Status last verified
- May 2026
- First submitted
- 3 Jun 2021
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data will be shared through National Institute of Mental Health Data Archive
Publications
Sangraula M, Kidane S, Holman A, Best C, Alam F, Andrew K, Cid-Vega A, Experton L, Rangel R, Montero RMJ, Ryder S, Ungureanu F, Assoudeh E, Baraki L, Day H, Wong E, Yamin I, Brown A, Kohrt B. Adapting on-the-go in NYC: Ongoing implementation strategy and cultural adaptations of Problem Management Plus (PM+), a non-clinician delivered mental health intervention. Res Sq [Preprint]. 2026 Sep 30:rs.3.rs-10419563. doi: 10.21203/rs.3.rs-10419563/v1.
PubMed 42856729
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REstoring Mental Health Through COmmUnity-based Psychological (RECOUP-NY)
- ClinicalTrials.gov ID
- NCT04913766
- Acronym / sponsor ID
- RECOUP-NY / R01MH127767
- Conditions
- Depression, Anxiety, Psychological Distress, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,206 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- The New School, Duke University, Human Sciences Research Council
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 4 Jun 2021 (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.
The goal is to improve mental health. The study will evaluate the impact of community-based mental health services. Successful completion of this study will contribute to the National Institute of Mental Health Strategic Plan employing implementation science to maximize the public health impact of research for effectiveness and reach of mental health services in the United States.
Detailed description
There is a need for delivery of psychological interventions by non-specialists when specialists are unable to meet the service demand. In the United States, training staff at community-based organizations to deliver psychological support has been highlighted as a way to increase availability of mental health services and increase access to mental health care, particularly for underserved populations. This study employs a mental health task-sharing model by partnering with community based organizations in New York City to train community based organizations staff without professional mental health training to deliver mental health services. This study examine the impact of community based organizations staff delivering mental health services to reduce mental health problems. This study is a cluster randomized control trial in New York City comparing Services as Usual arm and delivery of mental health services with Problem Management Plus (Intervention arm) among participating community based organizations. The target condition will be general psychological distress. This study will evaluate mental health outcomes populations served by community based organizations integrating Problem Management Plus into their other activities compared to community based organizations delivering services as usual. This study will evaluate implementation science outcomes to inform policy recommendations for of community-based delivery of psychological interventions. Successful completion of these aims will contribute to the 2020 National Institute of Mental Health Strategic Plan. Specifically, a) employing implementation science to maximize the public health impact of research for improving effectiveness and reach of mental health services, b) strengthening research-practice partnerships to expedite adoption, sustained implementation, and continuous improvement of evidence-based mental health services, and c) developing innovative service delivery models to dramatically improve outcomes of mental health services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Services as usual | Active comparator | Behavioral: Services as UsualPersons screening positive for depression will be referred from community-based organizations. The referrals will be made to mental health specialists who will provide care based on their standard of care. |
| Problem Management Plus | Experimental | Behavioral: Problem Management PlusPersons screening positive for depression will be offered Problem Management Plus delivered by community based organization staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Persons with Patient Health Questionnaire 4 scores equal to or above 3
- Functional impairment associated with psychological distress
Key exclusion criteria (3 listed)
- Acute suicide risk
- Patient Health Questionnaire 4 score below 3
- No functional impairment
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 |
|---|---|---|
| Problem Management PlusFive session psychological intervention focusing on problem management skills. | Behavioural | Problem Management Plus |
| Services as UsualMental health services provided by a mental health specialists according to their standard practices of care | Behavioural | Services as usual |
Primary outcome
Psychological Outcome Profiles Questionnaire; Unabbreviated scale title "Psychological Outcome Profiles questionnaire"
Time frame: 20 weeks after baseline assessment
4-item self-report questionnaire that is a personalized measure of psychological distress.
3 secondary outcomes
Patient Health Questionnaire 9; Unabbreviated scale title "Patient Health Questionnaire 9"
Time frame: 20 weeks after baseline assessment
Generalized Anxiety Disorder 7; Unabbreviated scale title "Generalized Anxiety Disorder 7"
Time frame: 20 weeks after baseline assessment
Posttraumatic Stress Disorder Checklist 5; Unabbreviated scale title "Posttraumatic Stress Disorder Checklist 5"
Time frame: 20 weeks after baseline assessment
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 28 May 2026.
- Derived from this study: PubMed 42856729Sangraula M, Kidane S, Holman A, Best C, Alam F, Andrew K, Cid-Vega A, Experton L, Rangel R, Montero RMJ, Ryder S, Ungureanu F, Assoudeh E, Baraki L, Day H, Wong E, Yamin I, Brown A, Kohrt B. Adapting on-the-go in NYC: Ongoing implementation strategy and cultural adaptations of Problem Management Plus (PM+), a non-clinician delivered mental health intervention. Res Sq [Preprint]. 2026 Sep 30:rs.3.rs-10419563. doi: 10.21203/rs.3.rs-10419563/v1.
- Individual participant dataSharing planned: Yes. Individual Participant Data will be shared through National Institute of Mental Health Data Archive
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Brandon Kohrt, MD, PhD principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Management Plus and Services as Usual in people with Depression and Anxiety, run by George Washington 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 3 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 28 May 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?
Psychological Outcome Profiles Questionnaire; Unabbreviated scale title "Psychological Outcome Profiles questionnaire" (time frame: 20 weeks after baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04913766, which also lists 1 linked publication.
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 28 May 2026.