Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-03 @ 10:51 PM
Study NCT ID:
NCT06185959
Status:
RECRUITING
Last Update Posted:
2025-05-25
First Post:
2023-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating a New Mental Health Group for Asians and Asian Americans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2023-12-15', 'studyFirstSubmitQcDate': '2023-12-15', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Once at baseline, once at 6 weeks, once at 12 weeks', 'description': 'Depression symptoms assessed on 4-point Likert scale. Score range from 0 to 27, with higher scores representing more severe depression symptoms'}, {'measure': 'Generalized Anxiety Disorder Screener-7 (GAD-7)', 'timeFrame': 'Once at baseline, once at 6 weeks, once at 12 weeks', 'description': 'Anxiety symptoms assessed on 4-point Likert scale. Score range from 0 to 21, with higher scores representing more severe anxiety symptoms'}], 'secondaryOutcomes': [{'measure': 'Social Connectedness Scale', 'timeFrame': 'Once at baseline, once at 12 weeks', 'description': 'Subjective social connectedness assessed on 6-point Likert scale. Score range from 20 to 120, with higher scores representing higher perceived social connectedness'}, {'measure': 'Rosenberg Self-Esteem Scale', 'timeFrame': 'Once at baseline, once at 12 weeks', 'description': 'Subjective self-esteem assessed on 4-point Likert scale. Score range from 10 to 40, with higher scores representing higher self-esteem'}, {'measure': 'Self-Stigma of Seeking Help Scale', 'timeFrame': 'Once at baseline, once at 12 weeks', 'description': 'Help-seeking self-stigma assessed on 5-point Likert scale. Score range from 10 to 50, with higher scores representing higher self-stigma of seeking help'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Health Issue']}, 'descriptionModule': {'briefSummary': "This study's overarching aim is to evaluate a new psychoeducation and process group for Asian and Asian American psychiatric outpatients. This is a 12 week mental health group which will focus on both educational content related to Asian mental health as well as increasing connection between group members. We hypothesize that participants in the group will experience a decrease in psychiatric symptoms at the conclusion of the group compared to their symptoms at the beginning of group. We also hypothesize that participants will feel more socially connected after the group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Age range is 18 years and older. All genders are eligible. For ethnic background, to be eligible for this study, participants must identify as Asian or Asian American due to the group under investigation being specifically designed as an Asian and Asian American Psychoeducation and Process Group.\n\nThe research study will be offered to all patients enrolling in the Asian and Asian American Psychoeducation and Process Group in the Stanford Department of Psychiatry \\& Behavioral Sciences. The purpose of this study is to evaluate patient experiences in this psychoeducation and process group, so participants will be limited to those enrolling in the group as part of their clinical treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older\n* Participants must identify as Asian or Asian American\n* Sufficient English proficiency to participate in a psychotherapy group conducted in English\n\nExclusion Criteria:\n\n* Unable to provide written informed consent\n* Elevated suicide risk (e.g. recent active suicidal ideation, past-year suicide attempt) without a current individual mental health provider\n* Any other challenges that would preclude participation in group psychotherapy'}, 'identificationModule': {'nctId': 'NCT06185959', 'briefTitle': 'Evaluating a New Mental Health Group for Asians and Asian Americans', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Examining the Feasibility and Impact of a Novel Psychoeducation and Process Group for Asian and Asian American Psychiatric Outpatients', 'orgStudyIdInfo': {'id': '72936'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients in a Psychoeducation and Process Group for Asian and Asian American Psychiatric Outpatients', 'interventionNames': ['Behavioral: Psychoeducation and Process Group for Asian and Asian American Psychiatric Outpatients']}], 'interventions': [{'name': 'Psychoeducation and Process Group for Asian and Asian American Psychiatric Outpatients', 'type': 'BEHAVIORAL', 'description': 'Participants will be individuals enrolling in a 1.5 hour weekly therapy group lasting 12 weeks and will be invited to participate in research on group processes and outcomes. The psychoeducation and process group will be a 12-session weekly closed group with 10-15 participants per group (2-3 groups total) conducted via Zoom to enhance accessibility and reduce barriers to care. Groups will be co-led by licensed clinical psychologists with experience providing both group psychotherapy and culturally responsive services. Group sessions will include brief check-ins, collaborative agenda-setting, a mini-didactic, individual reflection, and group discussion. The didactics curriculum will include topics such as intergenerational trauma, cultural differences in emotional expression, the model minority myth, family dynamics, racism, and positive connections to culture.', 'armGroupLabels': ['Patients in a Psychoeducation and Process Group for Asian and Asian American Psychiatric Outpatients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lisa Zhang, Ph.D.', 'role': 'CONTACT', 'email': 'lisaz@stanford.edu', 'phone': '650-721-8590'}], 'facility': 'Stanford University - Department of Psychiatry and Behavioral Sciences', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'centralContacts': [{'name': 'Lisa Zhang, PhD', 'role': 'CONTACT', 'email': 'lisaz@stanford.edu', 'phone': '650-721-8590'}], 'overallOfficials': [{'name': 'Lisa Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Melanie Hom, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Stacy Lin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Lisa Zhang', 'investigatorAffiliation': 'Stanford University'}}}}