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Evaluating a New Mental Health Group for Asians and Asian Americans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06185959
Recruitment Status : Not yet recruiting
First Posted : December 29, 2023
Last Update Posted : April 17, 2024
Sponsor:
Information provided by (Responsible Party):
Lisa Zhang, Stanford University

Tracking Information
First Submitted Date December 15, 2023
First Posted Date December 29, 2023
Last Update Posted Date April 17, 2024
Estimated Study Start Date June 1, 2024
Estimated Primary Completion Date June 1, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 15, 2023)
  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Once at baseline, once at 6 weeks, once at 12 weeks ]
    Depression symptoms assessed on 4-point Likert scale. Score range from 0 to 27, with higher scores representing more severe depression symptoms
  • Generalized Anxiety Disorder Screener-7 (GAD-7) [ Time Frame: Once at baseline, once at 6 weeks, once at 12 weeks ]
    Anxiety symptoms assessed on 4-point Likert scale. Score range from 0 to 21, with higher scores representing more severe anxiety symptoms
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 15, 2023)
  • Social Connectedness Scale [ Time Frame: Once at baseline, once at 12 weeks ]
    Subjective social connectedness assessed on 6-point Likert scale. Score range from 20 to 120, with higher scores representing higher perceived social connectedness
  • Rosenberg Self-Esteem Scale [ Time Frame: Once at baseline, once at 12 weeks ]
    Subjective self-esteem assessed on 4-point Likert scale. Score range from 10 to 40, with higher scores representing higher self-esteem
  • Self-Stigma of Seeking Help Scale [ Time Frame: Once at baseline, once at 12 weeks ]
    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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluating a New Mental Health Group for Asians and Asian Americans
Official Title Examining the Feasibility and Impact of a Novel Psychoeducation and Process Group for Asian and Asian American Psychiatric Outpatients
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

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.

The 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.

Condition Mental Health Issue
Intervention Behavioral: Psychoeducation and Process Group for Asian and Asian American Psychiatric Outpatients
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.
Study Groups/Cohorts Patients in a Psychoeducation and Process Group for Asian and Asian American Psychiatric Outpatients
Intervention: Behavioral: Psychoeducation and Process Group for Asian and Asian American Psychiatric Outpatients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: December 15, 2023)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2027
Estimated Primary Completion Date June 1, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 18 years and older
  • Participants must identify as Asian or Asian American
  • Sufficient English proficiency to participate in a psychotherapy group conducted in English

Exclusion Criteria:

  • Unable to provide written informed consent
  • Elevated suicide risk (e.g. recent active suicidal ideation, past-year suicide attempt) without a current individual mental health provider
  • Any other challenges that would preclude participation in group psychotherapy
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Lisa Zhang, PhD 650-721-8590 lisaz@stanford.edu
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT06185959
Other Study ID Numbers 72936
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Lisa Zhang, Stanford University
Original Responsible Party Same as current
Current Study Sponsor Stanford University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Lisa Zhang, PhD Stanford University
Principal Investigator: Melanie Hom, PhD Stanford University
Principal Investigator: Stacy Lin, PhD Stanford University
PRS Account Stanford University
Verification Date April 2024