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

Primary Purpose

Depression, Anxiety, Psychological Distress

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem Management Plus
Services as Usual
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Persons with Patient Health Questionnaire 9 scores between 10 and 20.

Exclusion Criteria:

  • Patient Health Questionnaire 9 scores below 10 or above 20.

Sites / Locations

  • New SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Services as usual

Problem Management Plus

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Psychological Outcome Profiles Questionnaire; Unabbreviated scale title "Psychological Outcome Profiles questionnaire"
4-item self-report questionnaire that is a personalized measure of psychological distress.

Secondary Outcome Measures

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
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
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
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
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

Full Information

First Posted
June 3, 2021
Last Updated
April 6, 2023
Sponsor
George Washington University
Collaborators
The New School, Duke University, Human Sciences Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT04913766
Brief Title
REstoring Mental Health After SARS-CoV-2 Through commUnity-based Psychological Services in New York City
Acronym
RECOUP-NY
Official Title
REstoring Mental Health After SARS-CoV-2 Through commUnity-based Psychological (RECOUP-NY)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University
Collaborators
The New School, Duke University, Human Sciences Research Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Psychological Distress, PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Outcome assessors will not be given information on what intervention services the participants are receiving.
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Services as usual
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Problem Management Plus
Arm Type
Experimental
Arm Description
Persons screening positive for depression will be offered Problem Management Plus delivered by community based organization staff.
Intervention Type
Behavioral
Intervention Name(s)
Problem Management Plus
Intervention Description
Five session psychological intervention focusing on problem management skills.
Intervention Type
Behavioral
Intervention Name(s)
Services as Usual
Intervention Description
Mental health services provided by a mental health specialists according to their standard practices of care
Primary Outcome Measure Information:
Title
Psychological Outcome Profiles Questionnaire; Unabbreviated scale title "Psychological Outcome Profiles questionnaire"
Description
4-item self-report questionnaire that is a personalized measure of psychological distress.
Time Frame
20 weeks after baseline assessment
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire 9; Unabbreviated scale title "Patient Health Questionnaire 9"
Description
9-item self-report scale to assess symptoms of depression, minimum value=0, maximum value=27, higher scores mean greater depression symptoms
Time Frame
20 weeks after baseline assessment
Title
Generalized Anxiety Disorder 7; Unabbreviated scale title "Generalized Anxiety Disorder 7"
Description
7-item self-report scale to assess symptoms of depression, minimum value=0, maximum value=21, greater scores mean more anxiety symptoms
Time Frame
20 weeks after baseline assessment
Title
Posttraumatic Stress Disorder Checklist 5; Unabbreviated scale title "Posttraumatic Stress Disorder Checklist 5"
Description
8-item self-report scale for symptoms of posttraumatic stress disorder, minimum value=0, maximum value=24, greater scores mean more posttraumatic stress symptoms
Time Frame
20 weeks after baseline assessment
Title
World Health Organization Disability Assessment Schedule; Unabbreviated scale title "World Health Organization Disability Assessment Schedule"
Description
12-item self report scale for disability, minimum score=0, maximum score=48, greater scores mean more disability
Time Frame
20 weeks after baseline assessment
Title
Coronavirus disease of 2019 experiences and attitudes tool; Unabbreviated scale title "Coronavirus disease of 2019 experiences and attitudes tool"
Description
18-item self-report scale assessing coronavirus pandemic experiences
Time Frame
20 weeks after baseline assessment
Other Pre-specified Outcome Measures:
Title
Reducing Tension Checklist, Unabbreviated title "Reducing Tension Checklist"
Description
10 items self-report scale for psychosocial skill use, minimum score=0, maximum score=30, greater scores mean more skill use
Time Frame
10 weeks after baseline assessment
Title
Intolerance of Uncertainty Scale-Short Form; Unabbreviated title "Intolerance of Uncertainty Scale-Short Form"
Description
12-item self-report of responses to uncertainty, ambiguous situations, and the future
Time Frame
10 weeks after baseline assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Brown, PhD
Phone
212-229-5727
Ext
3115
Email
brownad@newschool.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Manaswi Sangraula, PhD
Phone
212-229-5727
Ext
3115
Email
sangraum@newschool.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon Kohrt, MD, PhD
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New School
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Brown, PhD
Email
brownad@newschool.edu
First Name & Middle Initial & Last Name & Degree
Manaswi Sangraula, PhD
Email
sangraum@newschool.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual Participant Data will be shared through National Institute of Mental Health Data Archive
IPD Sharing Time Frame
After publication of the primary outcome findings
IPD Sharing Access Criteria
Standard access requirements for National Institute of Mental Health Data Archive

Learn more about this trial

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

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