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

• ClinicalTrials.gov Identifier: NCT01259427
• Recruitment Status: Completed
• First Posted: December 14, 2010
• Results First Posted: January 28, 2016
• Last Update Posted: March 8, 2016
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Major Depression With Psychotic Features	Behavioral: Ending Self Stigma (ESS); Behavioral: Health and Wellness Group	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 252 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Reducing Internalized Stigma In People With Serious Mental Illness
• Study Start Date: October 2011
• Actual Primary Completion Date: September 2014
• Actual Study Completion Date: September 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1: Ending Self Stigma; 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.	Behavioral: 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.
Active Comparator: Arm 2: Health and Wellness Group; 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).	Behavioral: 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).

Outcome Measures

Primary Outcome Measures :

1. Internalized Stigma of Mental Illness Inventory (Internalized Stigma) [ Time Frame: ~3 months (post-treatment) ]
   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.
2. Maryland Assessment of Recovery for Serious Mental Illness Scale (Recovery) [ Time Frame: ~3 1/2 months (post-treatment) ]
   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.
3. General Self-Efficacy Scale [ Time Frame: ~3 1/2 months (post-treatment) ]
   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.
4. Sense of Belonging Instrument (Belonging) [ Time Frame: ~3 1/2 months (post-treatment) ]
   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 :

1. Quality of Life [ Time Frame: ~3 1/2 months (post-treatment) ]
   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.
2. Social Engagement/Withdrawal [ Time Frame: ~3 1/2 months (post-treatment) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, District of Columbia

Washington DC VA Medical Center, Washington, DC

Washington, District of Columbia, United States, 20422

United States, Maryland

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, United States, 21201

Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD

Perry Point, Maryland, United States, 21902

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Amy L Drapalski, PhD; VA Maryland Health Care System, Baltimore

More Information

Publications of Results:

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. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01259427
• Other Study ID Numbers: IIR 09-340
• First Posted: December 14, 2010
• Results First Posted: January 28, 2016
• Last Update Posted: March 8, 2016
• Last Verified: February 2016

Keywords provided by VA Office of Research and Development:

Mental Disorders; Psychotic Disorders; Schizophrenia; Stigmatization; Mood Disorders; Schizophrenia and Disorders with Psychotic Feature

Additional relevant MeSH terms:

Disease; Schizophrenia; Bipolar Disorder; Mental Disorders; Psychotic Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders