Ignite Creation Date:
2024-05-05 @ 11:07 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01259427
Status:
COMPLETED
Last Update Posted:
2016-03-08
First Post:
2010-12-10
Brief Title:
Reducing Internalized Stigma in People With Serious Mental Illness
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Reducing Internalized Stigma In People With Serious Mental Illness
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESS
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 himherself 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 eg self-efficacy belonging recovery orientation Secondary objectives include assessing the effects of ESS on improving distal psychosocial outcomes eg 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 strategiestools to help participants address self-stigma The health and wellness group focuses on providing information education to help participants better manage health-related concerns eg 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
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 himherself 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 eg self-efficacy belonging recovery orientation Secondary objectives include assessing the effects of ESS on improving distal psychosocial outcomes eg 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 strategiestools to help participants address self-stigma The health and wellness group focuses on providing information education to help participants better manage health-related concerns eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None