An interventional study of Problem Management Plus and Services as Usual in Depression, Anxiety and Psychological Distress, sponsored by George Washington University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by George Washington University · Not applicable, Interventional, and Treatment
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.
There is a need for delivery of psychological interventions by non-specialists when specialists are unable to meet the 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 reduce mental health problems. 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. The target condition will be general psychological distress. This study will evaluate mental health outcomes populations served by community based organizations integrating Problem Management Plus into their other activities compared to community based organizations delivering services as usual. This study will evaluate implementation science outcomes to inform policy recommendations for of community-based delivery of psychological interventions. 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, 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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 1,206 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →George Washington University is the lead sponsor of 187 studies on the registry; 34 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Mental health services provided by a mental health specialists according to their standard practices of care
Psychological Outcome Profiles Questionnaire; Unabbreviated scale title "Psychological Outcome Profiles questionnaire"
4-item self-report questionnaire that is a personalized measure of psychological distress.
Time frame: 20 weeks after baseline assessment
Patient Health Questionnaire 9; Unabbreviated scale title "Patient Health Questionnaire 9"
9-item self-report scale to assess symptoms of depression, minimum value=0, maximum value=27, higher scores mean greater depression symptoms
Time frame: 20 weeks after baseline assessment
Generalized Anxiety Disorder 7; Unabbreviated scale title "Generalized Anxiety Disorder 7"
7-item self-report scale to assess symptoms of depression, minimum value=0, maximum value=21, greater scores mean more anxiety symptoms
Time frame: 20 weeks after baseline assessment
Posttraumatic Stress Disorder Checklist 5; Unabbreviated scale title "Posttraumatic Stress Disorder Checklist 5"
8-item self-report scale for symptoms of posttraumatic stress disorder, minimum value=0, maximum value=24, greater scores mean more posttraumatic stress symptoms
Time frame: 20 weeks after baseline assessment
Reducing Tension Checklist, Unabbreviated title "Reducing Tension Checklist"
10 items self-report scale for psychosocial skill use, minimum score=0, maximum score=30, greater scores mean more skill use
Time frame: 10 weeks after baseline assessment
Intolerance of Uncertainty Scale-Short Form; Unabbreviated title "Intolerance of Uncertainty Scale-Short Form"
12-item self-report of responses to uncertainty, ambiguous situations, and the future
Time frame: 10 weeks after baseline assessment
Plan to share: Yes — Individual Participant Data will be shared through National Institute of Mental Health Data Archive
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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George Washington University