Phase 2
N=248
Reducing Internalized Stigma in People With Serious Mental Illness
Schizophrenia · Schizoaffective Disorder · Bipolar Disorder · Major Depression With Psychotic Features
Bottom Line
View on ClinicalTrials.gov: NCT01259427 ↗Enrolled (actual)
248
Serious AEs
5.7%
Results posted
Jan 2016
Primary outcome: Primary: Internalized Stigma of Mental Illness Inventory (Internalized Stigma) — 2.2; 2.2; 2.1; 2.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ending Self Stigma (ESS) (Behavioral); Health and Wellness Group (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Internalized Stigma of Mental Illness Inventory (Internalized Stigma) |
2.2; 2.2; 2.1; 2.1 | — |
| PRIMARY Maryland Assessment of Recovery for Serious Mental Illness Scale (Recovery) |
94.9; 95.7; 96.7; 97.3 | — |
| PRIMARY General Self-Efficacy Scale |
3.6; 3.5; 3.6; 3.7 | — |
| PRIMARY Sense of Belonging Instrument (Belonging) |
40.4; 39.7; 39.6; 39.9; 46.6; 46.0 | — |
| SECONDARY Quality of Life |
4.3; 4.4; 4.6; 4.7 | — |
| SECONDARY Social Engagement/Withdrawal |
9.6; 9.5; 9.7; 10.0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01259427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.