Clinical trial NCT02734212: Ending Self Stigma for PTSD
Official title: Reducing Internalized Stigma Among Veterans With PTSD: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Stigmatization
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-04-12
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Veterans with PTSD report that stigma and fear of stigma have a chilling effect on their participation in mental health treatment. Despite the widely-documented effects of stigma on the recovery of individuals with mental illnesses and research demonstrating harmful consequences of internalized stigma, including decreased hope, self-esteem, personal motivation, and persistence regarding illness management, no interventions are currently available to assist Veterans with PTSD in combating the impact of internalized stigma. The goal of this research is to develop and pilot-test an intervention to provide Veterans with PTSD the skills to cope effectively with stigma and to mitigate the internalization of stigmatizing beliefs and stereotypes. To accomplish this purpose, Ending Self Stigma (ESS), an intervention composed of evidence-based methods for combating internalized stigma for serious mental illness, will be modified and tested to address issues particular to PTSD.

Detailed description: Stigma and fear of stigma are widespread among Veterans with PTSD and both have pernicious effects on Veterans' well-being and participation in mental health treatment. Internalized stigma is a harmful consequence of societal stigma, and has been associated with decreased hope, self-esteem, personal motivation, morale, self-regard, and persistence regarding illness management among individuals with a range of mental illnesses. Internalized stigma also has negative impacts on the recovery and well-being of Veterans with PTSD specifically, but no evidence-based interventions are currently available to assist Veterans with PTSD in combatting the impact of internalized stigma. Therefore, the purpose of this proposal is to develop and pilot-test an intervention to provide Veterans with PTSD the skills to cope effectively with stigma and to mitigate the internalization of stigmatizing beliefs and stereotypes. To that end, the investigators will modify Ending Self Stigma (ESS), an intervention composed of evidence-based strategies for combating internalized stigma for mental illness developed by the investigators' team, to specifically serve the needs of Veterans with PTSD.

This proposed project is composed of two phases. In Phase I, the investigators will produce an intervention and accompanying manual for the PTSD version of ESS (ESS-P), based upon the strategies and structure of the existing ESS intervention. To this end, the investigators will interview Veterans with a PTSD diagnosis to learn more about their experience with societal and internalized stigma associated with PTSD, plus other considerations and issues in addressing internalized stigma with such Veterans. Information gleaned in these qualitative interviews will form the basis of the investigators' adaption of the ESS intervention to specifically address the needs of Veterans with PTSD. In Phase II, the investigators will pilot-test ESS-P with Veterans who have PTSD, to evaluate the feasibility and acceptability of the intervention. In addition, the investigators will preliminarily estimate the effects of ESS-P through comparison to a control group receiving only an informational brochure on internalized stigma associated with PTSD. These feasibility, implementation and pilot outcome data will be used to further refine the intervention, towards the goal of conducting a future larger scale study of ESS-P within the VA system.

Eligibility criteria: Inclusion Criteria:

* a diagnosis of PTSD
* age between 18 and 70
* participation in mental health services at the VAMHCS
* sufficient clinical stability to participate

Exclusion Criteria:

* a diagnosis of serious mental illness

  * schizophrenia/schizoaffective disorder
  * bipolar disorder
  * major depression with psychotic features
* participation in the Phase I qualitative study

Primary outcomes:
measure: Internalized Stigma of Mental Illness Inventory (Internalized Stigma)
timeFrame: Basline and Post Treatment (~3 1/2 months)
Secondary outcomes:
measure: General Self-Efficacy
timeFrame: Baseline and Post Treatment (~3 1/2 months)
measure: Social Self-Efficacy
timeFrame: Baseline and Post Treatment (~3 1/2 months)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Amy L Drapalski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Drapalski AL, Aakre J, Brown CH, Romero E, Lucksted A. The Ending Self-Stigma for Posttraumatic Stress Disorder (ESS-P) Program: Results of a Pilot Randomized Trial. J Trauma Stress. 2021 Feb;34(1):69-80. doi: 10.1002/jts.22593. Epub 2020 Oct 15.