Trial Outcomes & Findings for Reducing Internalized Stigma in People With Serious Mental Illness (NCT NCT01259427)
NCT ID: NCT01259427
Last Updated: 2016-03-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
252 participants
Primary outcome timeframe
~3 months (post-treatment)
Results posted on
2016-03-08
Participant Flow
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 One participant was determined to be ineligible after randomization and was withdrawn from the study.
Participant milestones
| Measure |
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.
|
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.).
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
124
|
|
Overall Study
COMPLETED
|
106
|
110
|
|
Overall Study
NOT COMPLETED
|
18
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Internalized Stigma in People With Serious Mental Illness
Baseline characteristics by cohort
| Measure |
Arm 1: Ending Self Stigma
n=124 Participants
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
n=124 Participants
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).
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 8.8 • n=39 Participants
|
53.3 years
STANDARD_DEVIATION 9.5 • n=41 Participants
|
53.4 years
STANDARD_DEVIATION 9.2 • n=35 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
33 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=39 Participants
|
107 Participants
n=41 Participants
|
215 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: ~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.
Outcome measures
| Measure |
Arm 1: Ending Self Stigma
n=124 Participants
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
n=124 Participants
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).
|
|---|---|---|
|
Internalized Stigma of Mental Illness Inventory (Internalized Stigma)
Baseline
|
2.2 units on a scale
Standard Deviation .4
|
2.2 units on a scale
Standard Deviation .4
|
|
Internalized Stigma of Mental Illness Inventory (Internalized Stigma)
Post Treatment
|
2.1 units on a scale
Standard Deviation .4
|
2.1 units on a scale
Standard Deviation .5
|
PRIMARY outcome
Timeframe: ~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.
Outcome measures
| Measure |
Arm 1: Ending Self Stigma
n=124 Participants
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
n=124 Participants
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).
|
|---|---|---|
|
Maryland Assessment of Recovery for Serious Mental Illness Scale (Recovery)
Post-treatment
|
96.7 units on a scale
Standard Deviation 16.4
|
97.3 units on a scale
Standard Deviation 18.4
|
|
Maryland Assessment of Recovery for Serious Mental Illness Scale (Recovery)
Baseline
|
94.9 units on a scale
Standard Deviation 18.1
|
95.7 units on a scale
Standard Deviation 18.0
|
PRIMARY outcome
Timeframe: ~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.
Outcome measures
| Measure |
Arm 1: Ending Self Stigma
n=124 Participants
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
n=124 Participants
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).
|
|---|---|---|
|
General Self-Efficacy Scale
Baseline
|
3.6 unit on a scale
Standard Deviation .7
|
3.5 unit on a scale
Standard Deviation .8
|
|
General Self-Efficacy Scale
Post-treatment
|
3.6 unit on a scale
Standard Deviation .7
|
3.7 unit on a scale
Standard Deviation .7
|
PRIMARY outcome
Timeframe: ~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.
Outcome measures
| Measure |
Arm 1: Ending Self Stigma
n=124 Participants
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
n=124 Participants
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).
|
|---|---|---|
|
Sense of Belonging Instrument (Belonging)
Baseline: SOBI-P
|
40.4 units on a scale
Standard Deviation 5.5
|
39.7 units on a scale
Standard Deviation 6.1
|
|
Sense of Belonging Instrument (Belonging)
Post-Treatment: SOBI-P
|
39.6 units on a scale
Standard Deviation 5.8
|
39.9 units on a scale
Standard Deviation 5.4
|
|
Sense of Belonging Instrument (Belonging)
Baseline: SOBI-A
|
46.6 units on a scale
Standard Deviation 10.2
|
46.0 units on a scale
Standard Deviation 11.4
|
|
Sense of Belonging Instrument (Belonging)
Post-Treatment: SOBI-A
|
47.8 units on a scale
Standard Deviation 9.6
|
48.8 units on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: ~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.
Outcome measures
| Measure |
Arm 1: Ending Self Stigma
n=124 Participants
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
n=124 Participants
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).
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|---|---|---|
|
Quality of Life
Baseline
|
4.3 units on a scale
Standard Deviation 1.3
|
4.4 units on a scale
Standard Deviation 1.5
|
|
Quality of Life
Post-treatment
|
4.6 units on a scale
Standard Deviation 1.3
|
4.7 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: ~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.
Outcome measures
| Measure |
Arm 1: Ending Self Stigma
n=124 Participants
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
n=124 Participants
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).
|
|---|---|---|
|
Social Engagement/Withdrawal
Baseline
|
9.6 unit on a scale
Standard Deviation 2.5
|
9.5 unit on a scale
Standard Deviation 2.3
|
|
Social Engagement/Withdrawal
Post-treatment
|
9.7 unit on a scale
Standard Deviation 2.4
|
10.0 unit on a scale
Standard Deviation 2.5
|
Adverse Events
Arm 1: Ending Self Stigma
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Health and Wellness Group
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Ending Self Stigma
n=124 participants at risk
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
n=124 participants at risk
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).
|
|---|---|---|
|
Psychiatric disorders
Psychiatric hospitalization
|
4.0%
5/124 • Number of events 5 • Duration of participants involvement in the study, up to ~11 months
|
4.0%
5/124 • Number of events 5 • Duration of participants involvement in the study, up to ~11 months
|
|
General disorders
Death
|
0.81%
1/124 • Number of events 1 • Duration of participants involvement in the study, up to ~11 months
|
1.6%
2/124 • Number of events 2 • Duration of participants involvement in the study, up to ~11 months
|
|
General disorders
Medical Hospitalization
|
0.81%
1/124 • Number of events 1 • Duration of participants involvement in the study, up to ~11 months
|
0.00%
0/124 • Duration of participants involvement in the study, up to ~11 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place