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

Not Applicable

Recruiting

• Conditions: Anxiety; Depression; PTSD; Psychological Distress

• Registration Number: NCT04913766
• Lead Sponsor: George Washington University

Brief 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 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 Timeline

• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-06-03
• Study First Posted: 2021-06-04
• Study Start: 2022-11-07
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-17
• Last Update Posted: 2025-06-22
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Psychological Outcome Profiles Questionnaire; Unabbreviated scale title "Psychological Outcome Profiles questionnaire"	20 weeks after baseline assessment	4-item self-report questionnaire that is a personalized measure of psychological distress.

Secondary Outcome Measures

Name	Time	Method
World Health Organization Disability Assessment Schedule; Unabbreviated scale title "World Health Organization Disability Assessment Schedule"	20 weeks after baseline assessment	12-item self report scale for disability, minimum score=0, maximum score=48, greater scores mean more disability
Patient Health Questionnaire 9; Unabbreviated scale title "Patient Health Questionnaire 9"	20 weeks after baseline assessment	9-item self-report scale to assess symptoms of depression, minimum value=0, maximum value=27, higher scores mean greater depression symptoms
Generalized Anxiety Disorder 7; Unabbreviated scale title "Generalized Anxiety Disorder 7"	20 weeks after baseline assessment	7-item self-report scale to assess symptoms of depression, minimum value=0, maximum value=21, greater scores mean more anxiety symptoms
Posttraumatic Stress Disorder Checklist 5; Unabbreviated scale title "Posttraumatic Stress Disorder Checklist 5"	20 weeks after baseline assessment	8-item self-report scale for symptoms of posttraumatic stress disorder, minimum value=0, maximum value=24, greater scores mean more posttraumatic stress symptoms

Trial Locations

Locations (1)

New School; 🇺🇸 New York, New York, United States