NCT03820297

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

August 19, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

January 25, 2019

Last Update Submit

May 19, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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. 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

    23 weeks

Secondary Outcomes (3)

  • Changes in social support

    23 weeks

  • Changes in patient depressive symptoms measured by Patient Health Questionnaire-9 (PHQ-9)

    23 weeks

  • Changes in patient anxiety symptoms associated with stigma reduction

    23 weeks

Study Arms (1)

Anti-Stigma Group

OTHER

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

Interventions

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

Anti-Stigma Group

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-reported Chinese heritage;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Mood DisordersAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Naomi Simon, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 29, 2019

Study Start

August 19, 2019

Primary Completion

March 13, 2020

Study Completion

March 13, 2020

Last Updated

May 20, 2020

Record last verified: 2020-05

Locations