Post Traumatic Stress DisorderESS-PNCT02734212
Ending Self Stigma for PTSD
A study testing Ending Self Stigma for PTSD and Enhanced Treatment as Usual in people with Post Traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Ending Self Stigma for PTSD and Enhanced Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of PTSD
- age between 18 and 70
- participation in mental health services at the VAMHCS
- sufficient clinical stability to participate
Who cannot join
- a diagnosis of serious mental illness
- schizophrenia/schizoaffective disorder
- bipolar disorder
- major depression with psychotic features
- participation in the Phase I qualitative study
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Official title: Reducing Internalized Stigma Among Veterans With PTSD: A Pilot Trial
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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Ending Self Stigma for PTSD, Enhanced Treatment as Usual
- Keywords
- Stigmatization
- Medical subject headings
- Stress Disorders, Post-Traumatic, Stereotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ending Self Stigma for PTSDBehavioural
Also called ESS-P
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 UsualOther
Also called ETAU
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Enhanced Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Basline and Post Treatment (~3 1/2 months)
Secondary outcomes (2)
General Self-Efficacy
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.
Measured: Baseline and Post Treatment (~3 1/2 months)
Social Self-Efficacy
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.
Measured: Baseline and Post Treatment (~3 1/2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Amy L Drapalski, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734212
- Sponsor's protocol ID
- D1432-P
- Other IDs
- 1I21RX001432-01
- Acronym
- ESS-P
- Status last verified
- Aug 2017
- First submitted
- 6 Apr 2016
- Last updated
- 25 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33058277
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Internalized Stigma Among Veterans With PTSD: A Pilot Trial
- ClinicalTrials.gov ID
- NCT02734212
- Acronym / sponsor ID
- ESS-P / D1432-P
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Stigmatization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Nov 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Posted 24 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ending Self-Stigma for PTSD | Experimental | Behavioral: Ending Self Stigma for PTSDEnding 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 | Other | Other: Enhanced Treatment as UsualThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a diagnosis of PTSD
- age between 18 and 70
- participation in mental health services at the VAMHCS
- sufficient clinical stability to participate
Key exclusion criteria (5 listed)
- a diagnosis of serious mental illness
- participation in the Phase I qualitative study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ending Self Stigma for PTSDAlso: ESS-PEnding 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. | Behavioural | Ending Self-Stigma for PTSD |
| Enhanced Treatment as UsualAlso: ETAUThe 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 |
Primary outcome
Internalized Stigma of Mental Illness Inventory (Internalized Stigma)
Time frame: Basline and Post Treatment (~3 1/2 months)
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.
2 secondary outcomes
General Self-Efficacy
Time frame: Baseline and Post Treatment (~3 1/2 months)
Social Self-Efficacy
Time frame: Baseline and Post Treatment (~3 1/2 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33058277Drapalski 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy L Drapalski, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ending Self Stigma for PTSD and Enhanced Treatment as Usual in people with Post Traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internalized Stigma of Mental Illness Inventory (Internalized Stigma) (time frame: Basline and Post Treatment (~3 1/2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02734212, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.