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Anti-stigma Intervention for Chinese American Older Adults

Primary Purpose

Mood Disorders, Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
10 sessions of ASGI
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mood Disorders

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Anti-Stigma Group

Arm Description

Complete a 10 weekly anti-stigma group intervention (ASGI) in addition to several self-report internalized stigma and psychiatric measures.

Outcomes

Primary Outcome Measures

Self stigma of mental illness scale
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
Recovery assessment scale
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
Self-protective Withdrawal and Secrecy scale
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. 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) 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

Changes in social support
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. 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 ). 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
Changes in patient depressive symptoms measured by Patient Health Questionnaire-9 (PHQ-9)
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
Changes in patient anxiety symptoms associated with stigma reduction
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

Full Information

First Posted
January 25, 2019
Last Updated
May 19, 2020
Sponsor
NYU Langone Health
Collaborators
Substance Abuse and Mental Health Services Administration (SAMHSA)
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1. Study Identification

Unique Protocol Identification Number
NCT03820297
Brief Title
Anti-stigma Intervention for Chinese American Older Adults
Official Title
Effects Of Anti-Stigma Intervention For Chinese American Older Adults With Mood And Anxiety Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 19, 2019 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Substance Abuse and Mental Health Services Administration (SAMHSA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorders, Anxiety Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anti-Stigma Group
Arm Type
Other
Arm Description
Complete a 10 weekly anti-stigma group intervention (ASGI) in addition to several self-report internalized stigma and psychiatric measures.
Intervention Type
Behavioral
Intervention Name(s)
10 sessions of ASGI
Intervention Description
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 Measure Information:
Title
Self stigma of mental illness scale
Description
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
Time Frame
23 weeks
Title
Recovery assessment scale
Description
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
Time Frame
23 weeks
Title
Self-protective Withdrawal and Secrecy scale
Description
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. 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) 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
Time Frame
23 weeks
Secondary Outcome Measure Information:
Title
Changes in social support
Description
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. 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 ). 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
Time Frame
23 weeks
Title
Changes in patient depressive symptoms measured by Patient Health Questionnaire-9 (PHQ-9)
Description
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
Time Frame
23 weeks
Title
Changes in patient anxiety symptoms associated with stigma reduction
Description
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
Time Frame
23 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi Simon, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Anti-stigma Intervention for Chinese American Older Adults

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