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Completed

NCT Number: NCT04913766

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

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders PTSD Psychological Distress Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New School

New York, 10036, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Problem Management Plus

Behavioral

Five session psychological intervention focusing on problem management skills.

Services as usual

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient Health Questionnaire 9; Unabbreviated scale title "Patient Health Questionnaire 9"

    Time frame: 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

  2. Generalized Anxiety Disorder 7; Unabbreviated scale title "Generalized Anxiety Disorder 7"

    Time frame: 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

  3. Posttraumatic Stress Disorder Checklist 5; Unabbreviated scale title "Posttraumatic Stress Disorder Checklist 5"

    Time frame: 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

Other outcomes

  1. Reducing Tension Checklist, Unabbreviated title "Reducing Tension Checklist"

    Time frame: 10 weeks after baseline assessment

    10 items self-report scale for psychosocial skill use, minimum score=0, maximum score=30, greater scores mean more skill use

  2. Intolerance of Uncertainty Scale-Short Form; Unabbreviated title "Intolerance of Uncertainty Scale-Short Form"

    Time frame: 10 weeks after baseline assessment

    12-item self-report of responses to uncertainty, ambiguous situations, and the future

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • Duke University
  • Human Sciences Research Council
  • The New School

Registry information

Official study title

REstoring Mental Health Through COmmUnity-based Psychological (RECOUP-NY)

Acronym: RECOUP-NY

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2021
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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