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Anti-stigma Intervention for Chinese American Older Adults

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820297
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
Substance Abuse and Mental Health Services Administration (SAMHSA)
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
Approximately 50 participants will be enrolled and screened to achieve 45 eligible patients with mood/anxiety disorders to complete a 10 weekly anti-stigma group intervention (ASGI) in addition to several self-report internalized stigma and psychiatric measures.This study will examine changes in internalized stigma and psychiatric symptoms pre- and post-ASGI with 3 months post-intervention follow-up.

Condition or disease Intervention/treatment Phase
Mood Disorders Anxiety Disorders Behavioral: 10 sessions of ASGI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects Of Anti-Stigma Intervention For Chinese American Older Adults With Mood And Anxiety Disorders
Actual Study Start Date : August 19, 2019
Actual Primary Completion Date : March 13, 2020
Actual Study Completion Date : March 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Anti-Stigma Group
Complete a 10 weekly anti-stigma group intervention (ASGI) in addition to several self-report internalized stigma and psychiatric measures.
Behavioral: 10 sessions of ASGI
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




Primary Outcome Measures :
  1. 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


  2. 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


  3. 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.

    1. Secrecy subscale: a 5-item Likert-type scale (1=strongly agree, 6=strongly disagree) assessing use of concealment of mental illness.

      Total score: 5 to 30 (summed score)

    2. Withdrawal subscale consists of 7 items (1=strongly agree, 6=strongly disagree) assessing "limiting social interaction to those who know about and tend to accept one's stigmatized condition".

    Total score: 6 to 42 (average score).

    For the overall scale, summed score will be used. Higher score means better outcome



Secondary Outcome Measures :
  1. 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.

    1. Social interaction sub-scale: patients are asked 4 items to describe their telephone and face-to-face interaction patterns during the past week (1=none, 2=1-2 people, 3=more than 2 people).

      Total score: 4 to 12 (summed score ).

    2. Satisfaction with social support sub-scale: they are asked to respond to 7 questions such as "Does it seem that your family and friends understand you most of the time, some of the time, or hardly ever?" (1=hardly ever, 2=some of the time, 3=most of the time).

    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


  2. 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


  3. 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820297


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Substance Abuse and Mental Health Services Administration (SAMHSA)
Investigators
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Principal Investigator: Naomi Simon, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03820297    
Other Study ID Numbers: 18-01236
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Mood Disorders
Pathologic Processes
Mental Disorders