Reducing Internalized Stigma in People With Serious Mental Illness

Schizophrenia Clinical Trial

— ESS  

Official title:

Reducing Internalized Stigma In People With Serious Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259427
• Other study ID #: IIR 09-340
• Status: Completed
• Phase: Phase 2
• First received: December 10, 2010
• Last updated: February 5, 2016
• Start date: October 2011
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depressive Disorder, Major
• Disease
• Major Depression With Psychotic Features
• Mental Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	VA Maryland Health Care System, Baltimore	Baltimore	Maryland
United States	Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD	Perry Point	Maryland
United States	Washington DC VA Medical Center, Washington, DC	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):171-8. doi: 10.1037/prj0000100. Epub 2014 Oct 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	~3 months (post-treatment)	No
Primary	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.	~3 1/2 months (post-treatment)	No
Primary	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.	~3 1/2 months (post-treatment)	No
Primary	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.	~3 1/2 months (post-treatment)	No
Secondary	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.	~3 1/2 months (post-treatment)	No
Secondary	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.	~3 1/2 months (post-treatment)	No