Overview

This trial is active, not recruiting.

Conditions schizophrenia, schizoaffective disorder, bipolar disorder, major depression with psychotic features
Treatments ending self stigma (ess), health and wellness group
Phase phase 2
Sponsor Department of Veterans Affairs
Start date October 2011
End date September 2014
Trial size 276 participants
Trial identifier NCT01259427, IIR 09-340

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
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)
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).
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).

Primary Outcomes

Measure
Internalized Stigma
time frame: 2 1/2 months (post-treatment)

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Reducing Internalized Stigma In People With Serious Mental Illness
Principal investigator Amy Lynne Drapalski, PhD
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 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: Enrollment for the project has concluded. We are completing groups and continuing to conduct post-treatment assessments, 6-month post-treatment assessments, and qualitative interviews.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.