Clinical trial NCT01259427: Reducing Internalized Stigma in People With Serious Mental Illness
Official title: Reducing Internalized Stigma In People With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Major Depression With Psychotic Features
Keywords: Mental Disorders
Psychotic Disorders
Schizophrenia
Stigmatization
Mood Disorders
Schizophrenia and Disorders with Psychotic Feature
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-12-14
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Internalized Stigma of Mental Illness Inventory (Internalized Stigma)
timeFrame: ~3 months (post-treatment)
measure: Maryland Assessment of Recovery for Serious Mental Illness Scale (Recovery)
timeFrame: ~3 1/2 months (post-treatment)
measure: General Self-Efficacy Scale
timeFrame: ~3 1/2 months (post-treatment)
measure: Sense of Belonging Instrument (Belonging)
timeFrame: ~3 1/2 months (post-treatment)
Secondary outcomes:
measure: Quality of Life
timeFrame: ~3 1/2 months (post-treatment)
measure: Social Engagement/Withdrawal
timeFrame: ~3 1/2 months (post-treatment)
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington DC VA Medical Center, Washington, DC
state: District of Columbia
city: Baltimore
country: United States
facility: VA Maryland Health Care System, Baltimore
state: Maryland
city: Perry Point
country: United States
facility: Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD
state: Maryland
Study officials:
affiliation: VA Maryland Health Care System, Baltimore
name: Amy L Drapalski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.