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Not recruiting

Observational Study

Sponsor:

George Washington University

Code:

NCT04913766

Conditions

Depression

Anxiety

Psychological Distress

PTSD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Problem Management Plus

Services as Usual

Study Details

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.

Conditions

Depression

Anxiety

Psychological Distress

PTSD

Study ID

NCT04913766

Start date

Oct 25, 2022

Status verified date

May, 2026

Completion date

Feb 9, 2026

Primary completion date

Feb 9, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1206 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

experimental: Problem Management Plus

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

Interventions

Problem Management Plus

Five session psychological intervention focusing on problem management skills.

Services as Usual

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

Primary outcome measure

  • Psychological Outcome Profiles Questionnaire; Unabbreviated scale title "Psychological Outcome Profiles questionnaire" [ Time Frame: 20 weeks after baseline assessment ]

Central Contacts and Locations

More Information

Sponsor

George Washington University

Last update posted

May 28, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-15. This information was provided to ClinicalTrials.gov by George Washington University on 2026-05-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.