Ending Self Stigma for PTSD

NCT02734212 | Completed Results

• 2 other identifiers: D1432-P1I21RX001432-01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Keywords

Stigmatization

Outcome Measures

Primary Outcomes (1)

• 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.

  Basline and Post Treatment (~3 1/2 months)

Secondary Outcomes (2)

• General Self-Efficacy

  Baseline and Post Treatment (~3 1/2 months)

• Social Self-Efficacy

  Baseline and Post Treatment (~3 1/2 months)

Study Arms (2)

Ending Self-Stigma for PTSD

EXPERIMENTAL

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.

Behavioral: Ending Self Stigma for PTSD

Enhanced Treatment as Usual

OTHER

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.

Other: Enhanced Treatment as Usual

Interventions

Ending Self Stigma for PTSD BEHAVIORAL

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.

Also known as: ESS-P

Ending Self-Stigma for PTSD

Enhanced Treatment as Usual OTHER

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.

Also known as: ETAU

Enhanced Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• a diagnosis of serious mental illness
• schizophrenia/schizoaffective disorder
• bipolar disorder
• major depression with psychotic features
• participation in the Phase I qualitative study

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• 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.

  PMID: 33058277 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Stereotyping

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Social Behavior; Behavior

Results Point of Contact

• Title: Dr. Amy Drapalski
• Organization: VISN 5 MIRECC

amy.drapalski@va.gov

410-637-1855

Study Officials

• Amy L Drapalski, PhD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors were blind with regards to participants condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 12, 2016
• Study Start: November 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 25, 2017
• Results First Posted: July 24, 2017

Record last verified: 2017-08

Locations

US (1)