SchizophreniaPhase 2ESSNCT01259427
Reducing Internalized Stigma in People With Serious Mental Illness
A Phase 2 study testing Ending Self Stigma (ESS) and Health and Wellness Group in people with Schizophrenia and Schizoaffective Disorder, run by VA Office of Research and Development at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- What is being tested?
- Ending Self Stigma (ESS) and Health and Wellness Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2011to Sep 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe or profound mental retardation by chart review
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, 21201
Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD
Perry Point, Maryland, 21902
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422
About this study
Official title: Reducing Internalized Stigma In People With Serious Mental Illness
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depression With Psychotic Features
- Being tested
- Ending Self Stigma (ESS), Health and Wellness Group
- Keywords
- Mental Disorders, Psychotic Disorders, Schizophrenia, Stigmatization, Mood Disorders, Schizophrenia and Disorders with Psychotic Feature
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder, Mental Disorders, Stereotyping, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ending Self Stigma (ESS)Behavioural
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 GroupBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Health and Wellness Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ~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.
Measured: ~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.
Measured: ~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.
Measured: ~3 1/2 months (post-treatment)
Secondary outcomes (2)
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.
Measured: ~3 1/2 months (post-treatment)
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.
Measured: ~3 1/2 months (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startOct 2011
- Primary completionSep 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Amy L Drapalski, PhD, Principal investigator, VA Maryland Health Care System, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259427
- Sponsor's protocol ID
- IIR 09-340
- Acronym
- ESS
- Status last verified
- Feb 2016
- First submitted
- 10 Dec 2010
- Last updated
- 8 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25313530Drapalski 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.
PubMed 36892916Drapalski 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.
PubMed 33234053Wastler 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.
PubMed 31414842Jahn 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.
PubMed 31233321
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Internalized Stigma In People With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT01259427
- Acronym / sponsor ID
- ESS / IIR 09-340
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 14 Dec 2010 (estimated)
- Results
- Posted 28 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Ending Self Stigma | Experimental | Behavioral: Ending Self Stigma (ESS)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. |
| Arm 2: Health and Wellness Group | Active comparator | Behavioral: Health and Wellness GroupHealth 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of Schizophrenia
- Schizoaffective disorder
- Bipolar Disorder
- or Major Depression with Psychotic Features
- Age 18 to 80
Key exclusion criteria (1 listed)
- Severe or profound mental retardation by chart review
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Arm 1: Ending Self Stigma |
| Health and Wellness GroupThe 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). | Behavioural | Arm 2: Health and Wellness Group |
Primary outcome
Internalized Stigma of Mental Illness Inventory (Internalized Stigma)
Time frame: ~3 months (post-treatment)
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.
Maryland Assessment of Recovery for Serious Mental Illness Scale (Recovery)
Time frame: ~3 1/2 months (post-treatment)
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.
General Self-Efficacy Scale
Time frame: ~3 1/2 months (post-treatment)
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.
Sense of Belonging Instrument (Belonging)
Time frame: ~3 1/2 months (post-treatment)
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.
2 secondary outcomes
Quality of Life
Time frame: ~3 1/2 months (post-treatment)
Social Engagement/Withdrawal
Time frame: ~3 1/2 months (post-treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25313530Yanos 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.
- Derived from this study: PubMed 36892916Drapalski 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.
- Derived from this study: PubMed 33234053Drapalski 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.
- Derived from this study: PubMed 31414842Wastler 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.
- Derived from this study: PubMed 31233321Jahn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy L Drapalski, PhD principal investigator
VA Maryland Health Care System, Baltimore
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ending Self Stigma (ESS) and Health and Wellness Group in people with Schizophrenia and Schizoaffective Disorder, run by VA Office of Research and Development at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internalized Stigma of Mental Illness Inventory (Internalized Stigma) (time frame: ~3 months (post-treatment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01259427, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.