REstoring Mental Health Through COmmUnity-based Psychological Services in New York City

NCT ID: NCT04913766

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-07

Study Completion Date

2026-06-30

Brief Summary

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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

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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

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Depression Anxiety Psychological Distress PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessors will not be given information on what intervention services the participants are receiving.

Study Groups

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Services as usual

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.

Group Type ACTIVE_COMPARATOR

Services as Usual

Intervention Type BEHAVIORAL

Mental health services provided by a mental health specialists according to their standard practices of care

Problem Management Plus

Persons screening positive for depression will be offered Problem Management Plus delivered by community based organization staff.

Group Type EXPERIMENTAL

Problem Management Plus

Intervention Type BEHAVIORAL

Five session psychological intervention focusing on problem management skills.

Interventions

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Problem Management Plus

Five session psychological intervention focusing on problem management skills.

Intervention Type BEHAVIORAL

Services as Usual

Mental health services provided by a mental health specialists according to their standard practices of care

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Persons with Patient Health Questionnaire 4 scores equal to or above 3
* Functional impairment associated with psychological distress

Exclusion Criteria

* Acute suicide risk
* Patient Health Questionnaire 4 score below 3
* No functional impairment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The New School

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

Human Sciences Research Council

OTHER_GOV

Sponsor Role collaborator

George Washington University

OTHER

Sponsor Role lead

Responsible Party

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Brandon A Kohrt, MD, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brandon Kohrt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Locations

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New School

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Adam Brown, PhD

Role: CONTACT

212-229-5727 ext. 3115

Manaswi Sangraula, PhD

Role: CONTACT

212-229-5727 ext. 3115

Facility Contacts

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Adam Brown, PhD

Role: primary

Manaswi Sangraula, PhD

Role: backup

Other Identifiers

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R01MH127767

Identifier Type: NIH

Identifier Source: org_study_id

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