Bipolar Disorder, Major Depression With Psychotic Features, Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Mental Disorders, Psychotic Disorders, Schizophrenia, Stigmatization, Mood Disorders, Schizophrenia and Disorders with Psychotic Feature
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.
Interventions
BEHAVIORALEnding 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.
BEHAVIORALHealth 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).
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Internalized Stigma of Mental Illness Inventory (Internalized Stigma) | ~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) | ~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 | ~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) | ~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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | ~3 1/2 months (post-treatment) | 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. |
| Social Engagement/Withdrawal | ~3 1/2 months (post-treatment) | 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. |
Countries
United States
Participant flow
Pre-assignment details
Three participants were consented but indicated that they were unable to continue their participation prior to completing the baseline assessment. One participant was determined to be ineligible after randomization and was withdrawn from the study.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Ending 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. | 124 |
| Arm 2: Health and Wellness Group 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). | 124 |
| Total | 248 |
Baseline characteristics
| Characteristic | Arm 1: Ending Self Stigma | Arm 2: Health and Wellness Group | Total |
|---|---|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 8.8 | 53.3 years STANDARD_DEVIATION 9.5 | 53.4 years STANDARD_DEVIATION 9.2 |
| Sex: Female, Male Female | 16 Participants | 17 Participants | 33 Participants |
| Sex: Female, Male Male | 108 Participants | 107 Participants | 215 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 124 | 0 / 124 |
| serious Total, serious adverse events | 7 / 124 | 7 / 124 |
Outcome results
Primary
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.
Time frame: ~3 1/2 months (post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Ending Self Stigma | General Self-Efficacy Scale | Baseline | 3.6 unit on a scale | Standard Deviation 0.7 |
| Arm 1: Ending Self Stigma | General Self-Efficacy Scale | Post-treatment | 3.6 unit on a scale | Standard Deviation 0.7 |
| Arm 2: Health and Wellness Group | General Self-Efficacy Scale | Baseline | 3.5 unit on a scale | Standard Deviation 0.8 |
| Arm 2: Health and Wellness Group | General Self-Efficacy Scale | Post-treatment | 3.7 unit on a scale | Standard Deviation 0.7 |
Primary
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.
Time frame: ~3 months (post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Ending Self Stigma | Internalized Stigma of Mental Illness Inventory (Internalized Stigma) | Baseline | 2.2 units on a scale | Standard Deviation 0.4 |
| Arm 1: Ending Self Stigma | Internalized Stigma of Mental Illness Inventory (Internalized Stigma) | Post Treatment | 2.1 units on a scale | Standard Deviation 0.4 |
| Arm 2: Health and Wellness Group | Internalized Stigma of Mental Illness Inventory (Internalized Stigma) | Baseline | 2.2 units on a scale | Standard Deviation 0.4 |
| Arm 2: Health and Wellness Group | Internalized Stigma of Mental Illness Inventory (Internalized Stigma) | Post Treatment | 2.1 units on a scale | Standard Deviation 0.5 |
Primary
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.
Time frame: ~3 1/2 months (post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Ending Self Stigma | Maryland Assessment of Recovery for Serious Mental Illness Scale (Recovery) | Baseline | 94.9 units on a scale | Standard Deviation 18.1 |
| Arm 1: Ending Self Stigma | Maryland Assessment of Recovery for Serious Mental Illness Scale (Recovery) | Post-treatment | 96.7 units on a scale | Standard Deviation 16.4 |
| Arm 2: Health and Wellness Group | Maryland Assessment of Recovery for Serious Mental Illness Scale (Recovery) | Baseline | 95.7 units on a scale | Standard Deviation 18 |
| Arm 2: Health and Wellness Group | Maryland Assessment of Recovery for Serious Mental Illness Scale (Recovery) | Post-treatment | 97.3 units on a scale | Standard Deviation 18.4 |
Primary
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.
Time frame: ~3 1/2 months (post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Ending Self Stigma | Sense of Belonging Instrument (Belonging) | Baseline: SOBI-P | 40.4 units on a scale | Standard Deviation 5.5 |
| Arm 1: Ending Self Stigma | Sense of Belonging Instrument (Belonging) | Post-Treatment: SOBI-P | 39.6 units on a scale | Standard Deviation 5.8 |
| Arm 1: Ending Self Stigma | Sense of Belonging Instrument (Belonging) | Baseline: SOBI-A | 46.6 units on a scale | Standard Deviation 10.2 |
| Arm 1: Ending Self Stigma | Sense of Belonging Instrument (Belonging) | Post-Treatment: SOBI-A | 47.8 units on a scale | Standard Deviation 9.6 |
| Arm 2: Health and Wellness Group | Sense of Belonging Instrument (Belonging) | Post-Treatment: SOBI-A | 48.8 units on a scale | Standard Deviation 11.2 |
| Arm 2: Health and Wellness Group | Sense of Belonging Instrument (Belonging) | Baseline: SOBI-P | 39.7 units on a scale | Standard Deviation 6.1 |
| Arm 2: Health and Wellness Group | Sense of Belonging Instrument (Belonging) | Baseline: SOBI-A | 46.0 units on a scale | Standard Deviation 11.4 |
| Arm 2: Health and Wellness Group | Sense of Belonging Instrument (Belonging) | Post-Treatment: SOBI-P | 39.9 units on a scale | Standard Deviation 5.4 |
Secondary
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.
Time frame: ~3 1/2 months (post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Ending Self Stigma | Quality of Life | Baseline | 4.3 units on a scale | Standard Deviation 1.3 |
| Arm 1: Ending Self Stigma | Quality of Life | Post-treatment | 4.6 units on a scale | Standard Deviation 1.3 |
| Arm 2: Health and Wellness Group | Quality of Life | Baseline | 4.4 units on a scale | Standard Deviation 1.5 |
| Arm 2: Health and Wellness Group | Quality of Life | Post-treatment | 4.7 units on a scale | Standard Deviation 1.4 |
Secondary
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.
Time frame: ~3 1/2 months (post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Ending Self Stigma | Social Engagement/Withdrawal | Baseline | 9.6 unit on a scale | Standard Deviation 2.5 |
| Arm 1: Ending Self Stigma | Social Engagement/Withdrawal | Post-treatment | 9.7 unit on a scale | Standard Deviation 2.4 |
| Arm 2: Health and Wellness Group | Social Engagement/Withdrawal | Baseline | 9.5 unit on a scale | Standard Deviation 2.3 |
| Arm 2: Health and Wellness Group | Social Engagement/Withdrawal | Post-treatment | 10.0 unit on a scale | Standard Deviation 2.5 |