Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Cluster randomized controlled trial
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
Outcome assessors will not be given information on what intervention services the participants are receiving.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
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.
  • Behavioral: Services as Usual
    Mental health services provided by a mental health specialists according to their standard practices of care
Experimental
Problem Management Plus
Persons screening positive for depression will be offered Problem Management Plus delivered by community based organization staff.
  • Behavioral: Problem Management Plus
    Five session psychological intervention focusing on problem management skills.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
George Washington University

Study Contact

Adam Brown, PhD
212-229-5727
brownad@newschool.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.