- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03820297
Anti-stigma Intervention for Chinese American Older Adults
Effects Of Anti-Stigma Intervention For Chinese American Older Adults With Mood And Anxiety Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Self-reported Chinese heritage;
- 55 years or older
- Mandarin and/or Cantonese speaking and ability to read and/or comprehend spoken Chinese language.
- Currently receiving treatment from a mental health provider at Gouverneur Medical Center Asian Bicultural Clinic (GMC ABC) and willing to continue mental health care through the study.
- Willing to provide release for communication between primary mental health care provider and study staff throughout the study.
- Documented by mental health provider after consent for release of information as having mood and anxiety disorder diagnosis in the past year;
- A willingness to participate in the ASGI with stated availability;
- Able and willing to provide informed consent.
Exclusion Criteria:
- Lifetime psychosis, neurocognitive, or significant neurological disorders;
- Current manic episode;
- Past 6 months of alcohol/substance use disorder;
- Serious safety concerns of suicide or homicide.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Anti-Stigma Group
Complete a 10 weekly anti-stigma group intervention (ASGI) in addition to several self-report internalized stigma and psychiatric measures.
|
10-session intervention will occur weekly for 45 minutes per session: psychoeducation about mood and anxiety disorders, focusing on identification of risk factors and biological theory to counter stigma; psychoeducation regarding 'therapeutic modules' (psychotropics and psychotherapy) to treat depression, with an emphasis on the importance of psychiatric treatment adherence, providing behavioral strategies for anticipated and experienced forms of mental illness related work, social, or family discrimination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self stigma of mental illness scale
Time Frame: 23 weeks
|
This 40-item self-report scale assesses the extent of patient self-stigma. Items are rated on a 9-point Likert-type scale (1= Strongly Disagree; 9= Strongly Agree). Total score from 1 to 9 (average score) Higher score means worse outcome |
23 weeks
|
Recovery assessment scale
Time Frame: 23 weeks
|
Empowerment will be assessed using the 15-item scale from the Recovery Assessment Scale. This scale measures domains of recovery including 1) personal confidence and hope 2) willingness to ask for help 3) goal and success orientation 4) reliance on others 5) symptom coping. Patients are asked to describe themselves using a 5-point agreement scale (1= strongly disagree, 5= strongly agree) regarding their recovery. Total score from15 to 75 (summed score) Higher score means better outcome |
23 weeks
|
Self-protective Withdrawal and Secrecy scale
Time Frame: 23 weeks
|
Changes in use of self-protective withdrawal and secrecy as a strategy for coping with public stigma will be evaluated using two scales to assess patients' responses to their stigmatized status.
Total score: 6 to 42 (average score). For the overall scale, summed score will be used. Higher score means better outcome |
23 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in social support
Time Frame: 23 weeks
|
The subjective support and social interaction subscales from the Abbreviated Duke Social Support Scale (ADSSS) will be used to measure changes in social support. It is an 11-item Likert-type scalewhich has been shown to correlate well with mental and physical health outcomes.
Total score: 7 to 21 (summed score) For the overall scale, total score from 11 to 33 (summed score of two subscales). A higher score means better outcome |
23 weeks
|
Changes in patient depressive symptoms measured by Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 23 weeks
|
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item interview assessing depressive symptoms which is a reliable and valid measure of depression severity (0=not at all, 1=several days, 2=more than half the days, 3=nearly everyday). Total score: 27 (summed score). A higher score means worse outcome |
23 weeks
|
Changes in patient anxiety symptoms associated with stigma reduction
Time Frame: 23 weeks
|
The Generalized Anxiety Disorder 7-item Scale (GAD-7) is a 7-item interview assessing anxiety symptoms (0=not at all, 1=several days, 2=more than half the days, 3=nearly everyday). Total score: 21 (summed score will be used). A higher score means worse outcome |
23 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-01236
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mood Disorders
-
Joliet Center for Clinical ResearchAbbottCompleted
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
National Institute of Mental Health (NIMH)Completed
-
National Institute of Mental Health (NIMH)Completed
-
University of Colorado, DenverCompletedMood Disorders | Irritable MoodUnited States
-
VA Office of Research and DevelopmentCompleted
-
Baskent UniversityZİYAFET UĞURLUCompletedDisaster; Personality | Disorder, MoodTurkey
-
Fayoum University HospitalCompletedKetamine-Induced Mood DisorderEgypt
-
Mayo ClinicCompletedMood Disorders in Children and AdolescentsUnited States
-
Taipei Veterans General Hospital, TaiwanRecruiting
Clinical Trials on 10 sessions of ASGI
-
University of OttawaRecruitingPain | EndometriosisCanada
-
University of California, San DiegoCompletedDepression | Anxiety Disorders and SymptomsUnited States
-
Suzana Erico Tanni MinamotoLiita Care ApSCompleted
-
Institut de cancérologie Strasbourg EuropeNot yet recruiting
-
UConn HealthNational Institute on Drug Abuse (NIDA)Completed
-
Johns Hopkins UniversityCenters for Medicare and Medicaid Services; Baltimore City Health DepartmentCompleted
-
University Hospital, Clermont-FerrandUniversité d'Auvergne; European Regional Development Fund; Regional Council of... and other collaboratorsUnknown
-
Dominique JANUELRecruiting
-
University of ThessalyCompleted
-
Hospital Clinico Universitario de SantiagoInstituto de Salud Carlos III; European Regional Development FundUnknownFall | Dizziness ChronicSpain