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Community-based Psychological Services for Mental Health (RECOUP-NY Trial)

N/A

Recruiting

Led By Brandon Kohrt, MD, PhD

Research Sponsored by George Washington University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

No functional impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks after baseline assessment

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve mental health and COVID-19 prevention behaviors among minority and vulnerable groups in New York City by training community workers to provide basic mental health support using Problem Management Plus (PM+).

Who is the study for?

This trial is for individuals in New York City who are experiencing depression, anxiety, or other psychological distress after SARS-CoV-2. Participants should have a certain score on a health questionnaire and be struggling with daily activities due to their mental state. People at acute suicide risk or without functional impairment cannot join.

What is being tested?

The study tests 'Problem Management Plus', a mental health service, against the usual services provided. It aims to see if this can improve behaviors related to preventing SARS-CoV-2 spread, vaccination uptake, and safe healthcare use among minority and vulnerable groups.

What are the potential side effects?

Since this trial involves psychological services rather than medication, traditional side effects like those seen with drugs are not expected. However, participants may experience emotional discomfort when discussing personal issues during therapy sessions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any disabilities that affect my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks after baseline assessment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks after baseline assessment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks after baseline assessment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Psychological Outcome Profiles Questionnaire; Unabbreviated scale title "Psychological Outcome Profiles questionnaire"

Secondary study objectives

Coronavirus disease of 2019 experiences and attitudes tool; Unabbreviated scale title "Coronavirus disease of 2019 experiences and attitudes tool"

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

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

+2 more

Other study objectives

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

Reducing Tension Checklist, Unabbreviated title "Reducing Tension Checklist"

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Problem Management PlusExperimental Treatment1 Intervention

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

Group II: Services as usualActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Problem Management Plus

2018

N/A

~120

0 / 1Eligibility criteria met