Reducing Internalized Stigma in People With Serious Mental Illness (ESS)
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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 |
- Internalized Stigma [ Time Frame: 2 1/2 months (post-treatment) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 276 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
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: 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:
We 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 will be a randomized trial of 276 veterans with SMI receiving outpatient mental health services at the VA Maryland Healthcare System. Participants will be randomly assigned to ESS or a general health and wellness group, which they will attend once a week for 9 weeks. ESS will focus on teaching strategies/tools to help participants address self-stigma. The health and wellness group will focus on providing information/education to help participants better manage health-related concerns (e.g. physical activity, nutrition). All participants will 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 will be 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:
We are currently collecting data.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of Schizophrenia
- Schizoaffective disorder
- Bipolar Disorder
- or Major Depression with Psychotic Features
- Age 18 to 80
- Receiving services at one of the 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| Contact: Amy L Drapalski, PhD | (410) 637-1855 | amy.drapalski@va.gov |
| United States, Maryland | |
| VA Maryland Health Care System, Baltimore | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Amy L Drapalski, PhD (410) 637-1855 amy.drapalski@va.gov | |
| Principal Investigator: Amy Lynne Drapalski, PhD | |
| Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD | Recruiting |
| Perry Point, Maryland, United States, 21902 | |
| Contact: Amy Drapalski, PhD 410-637-1855 amy.drapalski@va.gov | |
| Principal Investigator: | Amy Lynne Drapalski, PhD | VA Maryland Health Care System, Baltimore |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01259427 History of Changes |
| Other Study ID Numbers: | IIR 09-340 |
| Study First Received: | December 10, 2010 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Mental Disorders Psychotic Disorders Schizophrenia |
Stigmatization Mood Disorders Schizophrenia and Disorders with Psychotic Feature |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Affective Disorders, Psychotic Schizophrenia and Disorders with Psychotic Features Bipolar Disorder Depression |
Depressive Disorder Schizophrenia Depressive Disorder, Major Mood Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013