NCT01259427

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for phase_2 schizophrenia

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_2 schizophrenia

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 14, 2010

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
5 months until next milestone

Results Posted

Study results publicly available

January 28, 2016

Completed
Last Updated

March 8, 2016

Status Verified

February 1, 2016

Enrollment Period

2.9 years

First QC Date

December 10, 2010

Results QC Date

October 28, 2015

Last Update Submit

February 5, 2016

Conditions

SchizophreniaSchizoaffective DisorderBipolar DisorderMajor Depression With Psychotic Features

Keywords

Mental DisordersPsychotic DisordersSchizophreniaStigmatizationMood DisordersSchizophrenia and Disorders with Psychotic Feature

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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)

Secondary Outcomes (2)

  • Quality of Life

    ~3 1/2 months (post-treatment)

  • Social Engagement/Withdrawal

    ~3 1/2 months (post-treatment)

Study Arms (2)

Arm 1: Ending Self Stigma

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.

Behavioral: Ending Self Stigma (ESS)

Arm 2: Health and Wellness Group

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).

Behavioral: Health and Wellness Group

Interventions

Ending Self Stigma (ESS)BEHAVIORAL

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.

Arm 1: Ending Self Stigma
Health and Wellness GroupBEHAVIORAL

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).

Arm 2: Health and Wellness Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe or profound mental retardation by chart review

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD

Perry Point, Maryland, 21902, United States

Location

Related Publications (5)

  • 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.

    PMID: 25313530RESULT

  • Drapalski AL, Tonge N, Muralidharan A, Brown CH, Lucksted A. Even mild internalized stigma merits attention among adults with serious mental illness. Psychol Serv. 2023;20(Suppl 2):166-174. doi: 10.1037/ser0000744. Epub 2023 Mar 9.

    PMID: 36892916DERIVED

  • 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.

    PMID: 33234053DERIVED

  • 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.

    PMID: 31414842DERIVED

  • 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.

    PMID: 31233321DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersBipolar DisorderMental DisordersStereotypingMood Disorders

Interventions

Health

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersBipolar and Related DisordersSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Results Point of Contact

Title
Amy Drapalski
Organization
VISN 5 MIRECC
amy.drapalski@va.gov
410-637-1855

Study Officials

  • Amy L Drapalski, PhD

    VA Maryland Health Care System, Baltimore

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2010

First Posted

December 14, 2010

Study Start

October 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2015

Last Updated

March 8, 2016

Results First Posted

January 28, 2016

Record last verified: 2016-02

Locations

US(3)