Trial Outcomes & Findings for Ending Self Stigma for PTSD (NCT NCT02734212)
NCT ID: NCT02734212
Last Updated: 2017-09-25
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
NA
Target enrollment
57 participants
Primary outcome timeframe
Basline and Post Treatment (~3 1/2 months)
Results posted on
2017-09-25
Participant Flow
Participant milestones
| Measure |
Ending Self-Stigma for PTSD
Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD 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.
|
Enhanced Treatment as Usual
The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
COMPLETED
|
24
|
18
|
|
Overall Study
NOT COMPLETED
|
5
|
10
|
Reasons for withdrawal
| Measure |
Ending Self-Stigma for PTSD
Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD 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.
|
Enhanced Treatment as Usual
The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
10
|
Baseline Characteristics
Ending Self Stigma for PTSD
Baseline characteristics by cohort
| Measure |
Ending Self-Stigma for PTSD
n=29 Participants
Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD 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.
|
Enhanced Treatment as Usual
n=28 Participants
The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
53.6 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Basline and Post Treatment (~3 1/2 months)Population: Number analyzed in the rows differ from overall because 5 participants in the ESS-P and 10 in the eTAU did not complete the post-treatment assessment
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 |
Ending Self-Stigma for PTSD
n=29 Participants
Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD 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.
|
Enhanced Treatment as Usual
n=28 Participants
The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
|
|---|---|---|
|
Internalized Stigma of Mental Illness Inventory (Internalized Stigma)
Baseline
|
2.5 units on a scale
Standard Deviation 0.6
|
2.6 units on a scale
Standard Deviation 0.5
|
|
Internalized Stigma of Mental Illness Inventory (Internalized Stigma)
Post-treatment
|
2.1 units on a scale
Standard Deviation 0.6
|
2.5 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline and Post Treatment (~3 1/2 months)Population: Number analyzed in the rows differ from overall because 5 participants in the ESS-P and 10 in the eTAU did not complete the post-treatment assessment
The General Self-Efficacy subscale of Sherer's Self-Efficacy Scale was used to measure participant's general beliefs or expectations about their abilities. A total score is calculated by summing the responses on the items (range= 17-85). Higher score indicate greater general self-efficacy.
Outcome measures
| Measure |
Ending Self-Stigma for PTSD
n=29 Participants
Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD 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.
|
Enhanced Treatment as Usual
n=28 Participants
The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
|
|---|---|---|
|
General Self-Efficacy
Baseline
|
54.7 units on a scale
Standard Deviation 11.7
|
55.4 units on a scale
Standard Deviation 9.6
|
|
General Self-Efficacy
Post-Treatment
|
57.6 units on a scale
Standard Deviation 13.3
|
53.1 units on a scale
Standard Deviation 13.0
|
SECONDARY outcome
Timeframe: Baseline and Post Treatment (~3 1/2 months)Population: Number analyzed in the rows differ from overall because 5 participants in the ESS-P and 10 in the eTAU did not complete the post-treatment assessment
The Social Self-Efficacy subscale of Sherer's Self-Efficacy Scale was used to measure participant's beliefs or expectations about their abilities with regards to social interactions/relationships. A total score is calculated by summing the responses on the items (range= 5-30). Higher score indicate greater social self-efficacy.
Outcome measures
| Measure |
Ending Self-Stigma for PTSD
n=29 Participants
Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD 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.
|
Enhanced Treatment as Usual
n=28 Participants
The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
|
|---|---|---|
|
Social Self-Efficacy
Baseline
|
16.1 units on a scale
Standard Deviation 4.9
|
15.6 units on a scale
Standard Deviation 4.7
|
|
Social Self-Efficacy
Post-Treatment
|
18.2 units on a scale
Standard Deviation 4.5
|
15.7 units on a scale
Standard Deviation 5.8
|
Adverse Events
Ending Self-Stigma for PTSD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place