Clinical trial NCT04913766: REstoring Mental Health After SARS-CoV-2 Through commUnity-based Psychological Services in New York City
Official title: REstoring Mental Health After SARS-CoV-2 Through commUnity-based Psychological (RECOUP-NY)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Psychological Distress
PTSD
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: The New School
name: Duke University
name: Human Sciences Research Council
First posted: 2021-06-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Psychological Outcome Profiles Questionnaire; Unabbreviated scale title "Psychological Outcome Profiles questionnaire"
timeFrame: 20 weeks after baseline assessment
Secondary outcomes:
measure: Patient Health Questionnaire 9; Unabbreviated scale title "Patient Health Questionnaire 9"
timeFrame: 20 weeks after baseline assessment
measure: Generalized Anxiety Disorder 7; Unabbreviated scale title "Generalized Anxiety Disorder 7"
timeFrame: 20 weeks after baseline assessment
measure: Posttraumatic Stress Disorder Checklist 5; Unabbreviated scale title "Posttraumatic Stress Disorder Checklist 5"
timeFrame: 20 weeks after baseline assessment
measure: World Health Organization Disability Assessment Schedule; Unabbreviated scale title "World Health Organization Disability Assessment Schedule"
timeFrame: 20 weeks after baseline assessment
measure: Coronavirus disease of 2019 experiences and attitudes tool; Unabbreviated scale title "Coronavirus disease of 2019 experiences and attitudes tool"
timeFrame: 20 weeks after baseline assessment
Other outcomes:
measure: Reducing Tension Checklist, Unabbreviated title "Reducing Tension Checklist"
timeFrame: 10 weeks after baseline assessment
measure: Intolerance of Uncertainty Scale-Short Form; Unabbreviated title "Intolerance of Uncertainty Scale-Short Form"
timeFrame: 10 weeks after baseline assessment
Locations:
city: New York
country: United States
facility: New School
state: New York
Study officials:
affiliation: George Washington University
name: Brandon Kohrt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: