Mood DisordersNCT03820297
Anti-stigma Intervention for Chinese American Older Adults
A study testing 10 sessions of ASGI in people with Mood Disorders and Anxiety Disorders, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mood Disorders, Anxiety Disorders
- What is being tested?
- 10 sessions of ASGI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2019to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Effects Of Anti-Stigma Intervention For Chinese American Older Adults With Mood And Anxiety Disorders
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.
- Conditions
- Mood Disorders, Anxiety Disorders
- Being tested
- 10 sessions of ASGI
- Medical subject headings
- Mood Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 sessions of ASGIBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Anti-Stigma Group | Other | Complete a 10 weekly anti-stigma group intervention (ASGI) in addition to several self-report internalized stigma and psychiatric measures. Receives: Behavioral: 10 sessions of ASGI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 23 weeks
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
Measured: 23 weeks
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
Measured: 23 weeks
Secondary outcomes (3)
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
Measured: 23 weeks
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
Measured: 23 weeks
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
Measured: 23 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start19 Aug 2019
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Responsible party
- Sponsor
- Investigators
- Naomi Simon, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820297
- Sponsor's protocol ID
- 18-01236
- Status last verified
- May 2020
- First submitted
- 25 Jan 2019
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Anti-Stigma Intervention For Chinese American Older Adults With Mood And Anxiety Disorders
- ClinicalTrials.gov ID
- NCT03820297
- Acronym / sponsor ID
- 18-01236
- Conditions
- Mood Disorders, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-Stigma Group | Other | Behavioral: 10 sessions of ASGIComplete a 10 weekly anti-stigma group intervention (ASGI) in addition to several self-report internalized stigma and psychiatric measures. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 sessions of ASGI10-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 | Behavioural | Anti-Stigma Group |
Primary outcome
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
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
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
3 secondary outcomes
Changes in social support
Time frame: 23 weeks
Changes in patient depressive symptoms measured by Patient Health Questionnaire-9 (PHQ-9)
Time frame: 23 weeks
Changes in patient anxiety symptoms associated with stigma reduction
Time frame: 23 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi Simon, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 sessions of ASGI in people with Mood Disorders and Anxiety Disorders, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self stigma of mental illness scale (time frame: 23 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.