Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 9:40 AM
Study NCT ID:
NCT04913766
Status:
RECRUITING
Last Update Posted:
2025-06-22
First Post:
2021-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REstoring Mental Health Through COmmUnity-based Psychological Services in New York City
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors will not be given information on what intervention services the participants are receiving.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2021-06-03', 'studyFirstSubmitQcDate': '2021-06-03', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reducing Tension Checklist, Unabbreviated title "Reducing Tension Checklist"', 'timeFrame': '10 weeks after baseline assessment', 'description': '10 items self-report scale for psychosocial skill use, minimum score=0, maximum score=30, greater scores mean more skill use'}, {'measure': 'Intolerance of Uncertainty Scale-Short Form; Unabbreviated title "Intolerance of Uncertainty Scale-Short Form"', 'timeFrame': '10 weeks after baseline assessment', 'description': '12-item self-report of responses to uncertainty, ambiguous situations, and the future'}], 'primaryOutcomes': [{'measure': 'Psychological Outcome Profiles Questionnaire; Unabbreviated scale title "Psychological Outcome Profiles questionnaire"', 'timeFrame': '20 weeks after baseline assessment', 'description': '4-item self-report questionnaire that is a personalized measure of psychological distress.'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire 9; Unabbreviated scale title "Patient Health Questionnaire 9"', 'timeFrame': '20 weeks after baseline assessment', 'description': '9-item self-report scale to assess symptoms of depression, minimum value=0, maximum value=27, higher scores mean greater depression symptoms'}, {'measure': 'Generalized Anxiety Disorder 7; Unabbreviated scale title "Generalized Anxiety Disorder 7"', 'timeFrame': '20 weeks after baseline assessment', 'description': '7-item self-report scale to assess symptoms of depression, minimum value=0, maximum value=21, greater scores mean more anxiety symptoms'}, {'measure': 'Posttraumatic Stress Disorder Checklist 5; Unabbreviated scale title "Posttraumatic Stress Disorder Checklist 5"', 'timeFrame': '20 weeks after baseline assessment', 'description': '8-item self-report scale for symptoms of posttraumatic stress disorder, minimum value=0, maximum value=24, greater scores mean more posttraumatic stress symptoms'}, {'measure': 'World Health Organization Disability Assessment Schedule; Unabbreviated scale title "World Health Organization Disability Assessment Schedule"', 'timeFrame': '20 weeks after baseline assessment', 'description': '12-item self report scale for disability, minimum score=0, maximum score=48, greater scores mean more disability'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression', 'Anxiety', 'Psychological Distress', 'PTSD']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons with Patient Health Questionnaire 4 scores equal to or above 3\n* Functional impairment associated with psychological distress\n\nExclusion Criteria:\n\n* Acute suicide risk\n* Patient Health Questionnaire 4 score below 3\n* No functional impairment'}, 'identificationModule': {'nctId': 'NCT04913766', 'acronym': 'RECOUP-NY', 'briefTitle': 'REstoring Mental Health Through COmmUnity-based Psychological Services in New York City', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'REstoring Mental Health Through COmmUnity-based Psychological (RECOUP-NY)', 'orgStudyIdInfo': {'id': 'R01MH127767', 'link': 'https://reporter.nih.gov/quickSearch/R01MH127767', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Services as usual', 'description': '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.', 'interventionNames': ['Behavioral: Services as Usual']}, {'type': 'EXPERIMENTAL', 'label': 'Problem Management Plus', 'description': 'Persons screening positive for depression will be offered Problem Management Plus delivered by community based organization staff.', 'interventionNames': ['Behavioral: Problem Management Plus']}], 'interventions': [{'name': 'Problem Management Plus', 'type': 'BEHAVIORAL', 'description': 'Five session psychological intervention focusing on problem management skills.', 'armGroupLabels': ['Problem Management Plus']}, {'name': 'Services as Usual', 'type': 'BEHAVIORAL', 'description': 'Mental health services provided by a mental health specialists according to their standard practices of care', 'armGroupLabels': ['Services as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10036', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adam Brown, PhD', 'role': 'CONTACT', 'email': 'brownad@newschool.edu'}, {'name': 'Manaswi Sangraula, PhD', 'role': 'CONTACT', 'email': 'sangraum@newschool.edu'}], 'facility': 'New School', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Adam Brown, PhD', 'role': 'CONTACT', 'email': 'brownad@newschool.edu', 'phone': '212-229-5727', 'phoneExt': '3115'}, {'name': 'Manaswi Sangraula, PhD', 'role': 'CONTACT', 'email': 'sangraum@newschool.edu', 'phone': '212-229-5727', 'phoneExt': '3115'}], 'overallOfficials': [{'name': 'Brandon Kohrt, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'George Washington University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After publication of the primary outcome findings', 'ipdSharing': 'YES', 'description': 'Individual Participant Data will be shared through National Institute of Mental Health Data Archive', 'accessCriteria': 'Standard access requirements for National Institute of Mental Health Data Archive'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Washington University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The New School', 'class': 'OTHER'}, {'name': 'Duke University', 'class': 'OTHER'}, {'name': 'Human Sciences Research Council', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Brandon A Kohrt, MD, PhD', 'investigatorAffiliation': 'George Washington University'}}}}