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Reducing Internalized Stigma in People With Serious Mental Illness (ESS)

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ending Self Stigma (ESS)
Health and Wellness Group
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Mental Disorders, Psychotic Disorders, Schizophrenia, Stigmatization, Mood Disorders, Schizophrenia and Disorders with Psychotic Feature

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Schizophrenia
  • Schizoaffective disorder
  • Bipolar Disorder
  • or Major Depression with Psychotic Features
  • Age 18 to 80
  • Receiving services at one of VA Medical Center study sites
  • Ability and willingness to provide consent to participate
  • Agreement obtained from the treating clinician that the patient is clinically stable enough to participate in the study

Exclusion Criteria:

  • Severe or profound mental retardation by chart review

Sites / Locations

  • Washington DC VA Medical Center, Washington, DC
  • VA Maryland Health Care System, Baltimore
  • Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: Ending Self Stigma

Arm 2: Health and Wellness Group

Arm Description

Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.

Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).

Outcomes

Primary Outcome Measures

Internalized Stigma of Mental Illness Inventory (Internalized Stigma)
The Internalized Stigma of Mental Illness Inventory was used to measure of internalized or self-stigma. A total score is calculated by taking an average of the responses on the items (range=1 to 4). Higher total scores indicate greater internalized stigma.
Maryland Assessment of Recovery for Serious Mental Illness Scale (Recovery)
The Maryland Assessment of Recovery in Serious Mental Illness is a self-report measure of recovery in people with serious mental illness. A total score was calculated by summing item responses (range=25 to 125), with higher total scores indicating greater self-reported recovery.
General Self-Efficacy Scale
The General Self-efficacy measure was used to measure of self-efficacy. A total score was calculated by averaging the responses on the items (range=1 to 5), with higher scores indicating greater self-efficacy.
Sense of Belonging Instrument (Belonging)
The Sense of Belonging Instrument was used to measure perceived belongingness. The measure includes two subscales: the psychological experience of belonging (SOBI-P) and antecedents that foster belonging (SOBI-A). An average of the sum of the items in each subscale were used to calculate the total score for that subscale. The total score of the SOBI-P ranges from 18 to 72, with higher scores indicating less experienced belonging. The total score of the SOBI-A ranges from 14-56 with higher score indicating greater antecedents that foster belonging.

Secondary Outcome Measures

Quality of Life
The Satisfaction with Life in General item from the Brief Quality of Life Scale was used to assess self-reported life satisfaction. The item is rated on a 7-point scale that ranges from terrible to delighted (range=1 to 7), with greater scores indicating more satisfaction.
Social Engagement/Withdrawal
The total score of the Social Engagement/Withdrawal subscale of the Social Functioning Scale was used to measure social engagement. The total score ranges from 0 to 15 with higher scores indicating greater social engagement.

Full Information

First Posted
December 10, 2010
Last Updated
February 5, 2016
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01259427
Brief Title
Reducing Internalized Stigma in People With Serious Mental Illness
Acronym
ESS
Official Title
Reducing Internalized Stigma In People With Serious Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if Ending Self-Stigma (ESS), a 9-session group intervention designed to assist veterans with serious mental illness to develop skills (SMI) to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes, is more effective in reducing internalized stigma and its associated effects than an active comparison group.
Detailed Description
Background: Stigmatizing beliefs and attitudes about mental illness are prevalent and exposure to stigma is common among people with mental illness. The negative effects of stigma are compounded when a veteran with Serious Mental Illness (SMI) internalizes these stigmatizing assumptions and stereotypes. Internalized stigma refers to the process in which a person with mental illness cognitively or emotionally absorbs negative messages or stereotypes about mental illness and comes to believe them and apply them to him/herself. Internalized stigma is evident among veterans with SMI and can lead to decreased self-efficacy, increased depression, social withdrawal, and curtailed pursuit of recovery goals. Objectives: The investigators developed Ending Self Stigma (ESS), a 9-session group intervention to assist veterans with SMI to develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. The primary objectives of this project are to compare the effects of ESS to a general health and wellness group in: 1) reducing internalized stigma and 2) improving proximal psychosocial outcomes (e.g., self-efficacy, belonging, recovery orientation). Secondary objectives include assessing the effects of ESS on improving distal psychosocial outcomes (e.g., quality of life, social functioning) and examining if improvements are maintained 6-months post-treatment. Methods: This study is a randomized trial of veterans with SMI receiving outpatient mental health services from three VA Medical Centers. Participants are randomly assigned to ESS or a general health and wellness group, which they attend once a week for 9 weeks. ESS focuses on teaching strategies/tools to help participants address self-stigma. The health and wellness group focuses on providing information/ education to help participants better manage health-related concerns (e.g. physical activity, nutrition). Participants complete assessments at baseline, post-treatment, and 6-months post-treatment. A two-level mixed effects model with adjustment for baseline response will be used to address the primary and secondary aims. Qualitative data on veterans' experiences of and strategies for coping with internalized stigma are being collected from a subset of veterans from both conditions to compare experiences of veterans in both groups and explore any reasons for ESS drop-out. Status: Data collection for the project is completed. Analysis of 6-month post-treatment assessments and qualitative interviews are currently being conducted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depression With Psychotic Features
Keywords
Mental Disorders, Psychotic Disorders, Schizophrenia, Stigmatization, Mood Disorders, Schizophrenia and Disorders with Psychotic Feature

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Ending Self Stigma
Arm Type
Experimental
Arm Description
Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
Arm Title
Arm 2: Health and Wellness Group
Arm Type
Active Comparator
Arm Description
Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
Intervention Type
Behavioral
Intervention Name(s)
Ending Self Stigma (ESS)
Intervention Description
Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
Intervention Type
Behavioral
Intervention Name(s)
Health and Wellness Group
Intervention Description
The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
Primary Outcome Measure Information:
Title
Internalized Stigma of Mental Illness Inventory (Internalized Stigma)
Description
The Internalized Stigma of Mental Illness Inventory was used to measure of internalized or self-stigma. A total score is calculated by taking an average of the responses on the items (range=1 to 4). Higher total scores indicate greater internalized stigma.
Time Frame
~3 months (post-treatment)
Title
Maryland Assessment of Recovery for Serious Mental Illness Scale (Recovery)
Description
The Maryland Assessment of Recovery in Serious Mental Illness is a self-report measure of recovery in people with serious mental illness. A total score was calculated by summing item responses (range=25 to 125), with higher total scores indicating greater self-reported recovery.
Time Frame
~3 1/2 months (post-treatment)
Title
General Self-Efficacy Scale
Description
The General Self-efficacy measure was used to measure of self-efficacy. A total score was calculated by averaging the responses on the items (range=1 to 5), with higher scores indicating greater self-efficacy.
Time Frame
~3 1/2 months (post-treatment)
Title
Sense of Belonging Instrument (Belonging)
Description
The Sense of Belonging Instrument was used to measure perceived belongingness. The measure includes two subscales: the psychological experience of belonging (SOBI-P) and antecedents that foster belonging (SOBI-A). An average of the sum of the items in each subscale were used to calculate the total score for that subscale. The total score of the SOBI-P ranges from 18 to 72, with higher scores indicating less experienced belonging. The total score of the SOBI-A ranges from 14-56 with higher score indicating greater antecedents that foster belonging.
Time Frame
~3 1/2 months (post-treatment)
Secondary Outcome Measure Information:
Title
Quality of Life
Description
The Satisfaction with Life in General item from the Brief Quality of Life Scale was used to assess self-reported life satisfaction. The item is rated on a 7-point scale that ranges from terrible to delighted (range=1 to 7), with greater scores indicating more satisfaction.
Time Frame
~3 1/2 months (post-treatment)
Title
Social Engagement/Withdrawal
Description
The total score of the Social Engagement/Withdrawal subscale of the Social Functioning Scale was used to measure social engagement. The total score ranges from 0 to 15 with higher scores indicating greater social engagement.
Time Frame
~3 1/2 months (post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Schizophrenia Schizoaffective disorder Bipolar Disorder or Major Depression with Psychotic Features Age 18 to 80 Receiving services at one of VA Medical Center study sites Ability and willingness to provide consent to participate Agreement obtained from the treating clinician that the patient is clinically stable enough to participate in the study Exclusion Criteria: Severe or profound mental retardation by chart review
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy L Drapalski, PhD
Organizational Affiliation
VA Maryland Health Care System, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington DC VA Medical Center, Washington, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
VA Maryland Health Care System, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD
City
Perry Point
State/Province
Maryland
ZIP/Postal Code
21902
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25313530
Citation
Yanos PT, Lucksted A, Drapalski AL, Roe D, Lysaker P. Interventions targeting mental health self-stigma: A review and comparison. Psychiatr Rehabil J. 2015 Jun;38(2):171-178. doi: 10.1037/prj0000100. Epub 2014 Oct 13.
Results Reference
result
PubMed Identifier
33234053
Citation
Drapalski AL, Lucksted A, Brown CH, Fang LJ. Outcomes of Ending Self-Stigma, a Group Intervention to Reduce Internalized Stigma, Among Individuals With Serious Mental Illness. Psychiatr Serv. 2021 Feb 1;72(2):136-142. doi: 10.1176/appi.ps.201900296. Epub 2020 Nov 25.
Results Reference
derived
PubMed Identifier
31414842
Citation
Wastler H, Lucksted A, Phalen P, Drapalski A. Internalized stigma, sense of belonging, and suicidal ideation among veterans with serious mental illness. Psychiatr Rehabil J. 2020 Jun;43(2):91-96. doi: 10.1037/prj0000386. Epub 2019 Aug 15.
Results Reference
derived
PubMed Identifier
31233321
Citation
Jahn DR, Leith J, Muralidharan A, Brown CH, Drapalski AL, Hack S, Lucksted A. The influence of experiences of stigma on recovery: Mediating roles of internalized stigma, self-esteem, and self-efficacy. Psychiatr Rehabil J. 2020 Jun;43(2):97-105. doi: 10.1037/prj0000377. Epub 2019 Jun 24.
Results Reference
derived

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Reducing Internalized Stigma in People With Serious Mental Illness

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