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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01259427
First received: December 10, 2010
Last updated: February 5, 2016
Last verified: February 2016
  Purpose
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 Intervention Phase
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Major Depression With Psychotic Features
Behavioral: Ending Self Stigma (ESS)
Behavioral: Health and Wellness Group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Internalized Stigma In People With Serious Mental Illness

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Internalized Stigma of Mental Illness Inventory (Internalized Stigma) [ Time Frame: ~3 months (post-treatment) ] [ Designated as safety issue: No ]
    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) [ Time Frame: ~3 1/2 months (post-treatment) ] [ Designated as safety issue: No ]
    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 [ Time Frame: ~3 1/2 months (post-treatment) ] [ Designated as safety issue: No ]
    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) [ Time Frame: ~3 1/2 months (post-treatment) ] [ Designated as safety issue: No ]
    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 [ Time Frame: ~3 1/2 months (post-treatment) ] [ Designated as safety issue: No ]
    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 [ Time Frame: ~3 1/2 months (post-treatment) ] [ Designated as safety issue: No ]
    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.


Enrollment: 252
Study Start Date: October 2011
Study Completion Date: September 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259427

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:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01259427     History of Changes
Other Study ID Numbers: IIR 09-340 
Study First Received: December 10, 2010
Results First Received: October 28, 2015
Last Updated: February 5, 2016
Health Authority: United States: Federal Government

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
Depressive Disorder, Major
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Depressive Disorder
Mood Disorders

ClinicalTrials.gov processed this record on August 24, 2016