REstoring Mental Health After SARS-CoV-2 Through commUnity-based Psychological Services in New York City

Depression Clinical Trial

— RECOUP-NY  

Official title:

REstoring Mental Health After SARS-CoV-2 Through commUnity-based Psychological (RECOUP-NY)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04913766
• Other study ID #: R01MH127767
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: George Washington University
• Contact: Adam Brown, PhD
• Phone: 212-229-5727
• Email: brownad[@]newschool.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal is to improve mental health of minority and other vulnerable populations disproportionately affected by SARS-CoV-2. The study will evaluate the impact of mental health services on SARS-CoV-2 mitigation strategies such as prevention behaviors, receiving vaccinations, and safe healthcare utilization. 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, especially for minority groups and other underserved populations in the United States.

Description:

SARS-CoV-2 has had major mental health impacts across the United States. The economic, livelihood, social and other effects brought on by the pandemic have affected most of the national population, regardless of SARS-CoV-2 infection. New York City has had one of the highest SARS-CoV-2 mortality rates, and it has disproportionately affected National Institute of Health-designated United States health disparity populations (e.g., Black, Hispanic). In humanitarian crisis such as this, there is a need for delivery of psychological interventions by non-specialists when specialists are unable to meet the increased 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 (a) reduce the negative mental health consequences of the pandemic, and (b) improve public health behaviors to reduce the spread of SARS-CoV-2. 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 within the Thrive New York City consortium. The target condition will be depression. In Aim 1, this study will evaluate mental health outcomes of SARS-CoV-2 vulnerable populations served by community based organizations integrating Problem Management Plus into their other activities compared to community based organizations delivering services as usual. In Aim 2, this study will evaluate the difference between the Intervention and services as usual arms on SARS-CoV-2 risk prevention adherence among populations served by the community based organizations. In Aim 3, this study will evaluate implementation science outcomes to inform policy recommendations for of community-based delivery of psychological interventions and inclusion of mental health within the infectious disease response measures. 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, especially for minority groups and other underserved populations, 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 received in diverse communities and populations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Psychological Distress
• PTSD

Intervention

Behavioral:
• Problem Management Plus
Five session psychological intervention focusing on problem management skills.
• Services as Usual
Mental health services provided by a mental health specialists according to their standard practices of care

Locations

Country	Name	City	State
United States	New School	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
George Washington University	Duke University, Human Sciences Research Council, The New School

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reducing Tension Checklist, Unabbreviated title "Reducing Tension Checklist"	10 items self-report scale for psychosocial skill use, minimum score=0, maximum score=30, greater scores mean more skill use	10 weeks after baseline assessment
Other	Intolerance of Uncertainty Scale-Short Form; Unabbreviated title "Intolerance of Uncertainty Scale-Short Form"	12-item self-report of responses to uncertainty, ambiguous situations, and the future	10 weeks after baseline assessment
Primary	Psychological Outcome Profiles Questionnaire; Unabbreviated scale title "Psychological Outcome Profiles questionnaire"	4-item self-report questionnaire that is a personalized measure of psychological distress.	20 weeks after baseline assessment
Secondary	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	20 weeks after baseline assessment
Secondary	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	20 weeks after baseline assessment
Secondary	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	20 weeks after baseline assessment
Secondary	World Health Organization Disability Assessment Schedule; Unabbreviated scale title "World Health Organization Disability Assessment Schedule"	12-item self report scale for disability, minimum score=0, maximum score=48, greater scores mean more disability	20 weeks after baseline assessment
Secondary	Coronavirus disease of 2019 experiences and attitudes tool; Unabbreviated scale title "Coronavirus disease of 2019 experiences and attitudes tool"	18-item self-report scale assessing coronavirus pandemic experiences	20 weeks after baseline assessment