NCT04913766

Brief Summary

The goal is to improve mental health. The study will evaluate the impact of community-based mental health services. 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 in the United States.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable depression

Timeline
1mo left

Started Nov 2022

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Nov 2022Jun 2026

First Submitted

Initial submission to the registry

June 3, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 7, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

April 2, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

June 3, 2021

Last Update Submit

April 1, 2026

Conditions

PTSDDepressionAnxietyPsychological Distress

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

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

    20 weeks after baseline assessment

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

    20 weeks after baseline assessment

  • Posttraumatic Stress Disorder Checklist 5; Unabbreviated scale title "Posttraumatic Stress Disorder Checklist 5"

    20 weeks after baseline assessment

  • World Health Organization Disability Assessment Schedule; Unabbreviated scale title "World Health Organization Disability Assessment Schedule"

    20 weeks after baseline assessment

Other Outcomes (2)

  • Reducing Tension Checklist, Unabbreviated title "Reducing Tension Checklist"

    10 weeks after baseline assessment

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

    10 weeks after baseline assessment

Study Arms (2)

Services as usual

ACTIVE COMPARATOR

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

Problem Management Plus

EXPERIMENTAL

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

Behavioral: Problem Management Plus

Interventions

Problem Management PlusBEHAVIORAL

Five session psychological intervention focusing on problem management skills.

Problem Management Plus
Services as UsualBEHAVIORAL

Mental health services provided by a mental health specialists according to their standard practices of care

Services as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons with Patient Health Questionnaire 4 scores equal to or above 3
  • Functional impairment associated with psychological distress

You may not qualify if:

  • Acute suicide risk
  • Patient Health Questionnaire 4 score below 3
  • No functional impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New School

New York, New York, 10036, United States

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety DisordersStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • Brandon Kohrt, MD, PhD

    George Washington University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Brown, PhD

CONTACT

212-229-5727brownad@newschool.edu

Manaswi Sangraula, PhD

CONTACT

212-229-5727sangraum@newschool.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will not be given information on what intervention services the participants are receiving.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 4, 2021

Study Start

November 7, 2022

Primary Completion

February 9, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 2, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Individual Participant Data will be shared through National Institute of Mental Health Data Archive

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After publication of the primary outcome findings
Access Criteria
Standard access requirements for National Institute of Mental Health Data Archive

Locations

US(1)