Stress Disorders, Post-TraumaticPE+ERNCT04792775
PTSD Treatment and Emotion Regulation Skills Training for Veterans With Military Sexual Trauma (PE+ER)
A study testing PE+ER in people with Stress Disorders, Post-Traumatic and Anxiety Disorders, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Prior research has found that Veterans with military sexual trauma (MST) who have more difficulties with emotion regulation were more likely to drop out of PTSD treatment prematurely. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Mental Disorder
- What is being tested?
- PE+ER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2021to 19 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MST-related index event
- Diagnosis of PTSD related to MST assigned on the basis of the Clinician Administered PTSD Scale (CAPS; Weathers et al., 2013)
- Difficulties with emotion regulation as identified by the Difficulties with Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004; although there is no clinical cutoff for the DERS, a total score of 99 is indicative of one standard deviation above average difficulties with emotion regulation for women).
Who cannot join
- Having a household member who is already enrolled in the study
- Active psychosis or dementia at screening
- Suicidal ideation with clear intent
- Current moderate to severe Substance Use Disorder
- Concurrent enrollment in a clinical trial for PTSD or depression.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ralph H. Johnson VAMC
Charleston, South Carolina, 29401
About this study
Official title: PTSD Treatment and Emotion Regulation Skills Training for Veterans With Military Sexual Trauma
Prior research has found that Veterans with military sexual trauma (MST) who have more difficulties with emotion regulation were more likely to drop out of PTSD treatment prematurely. The purpose of this pilot study is to determine whether integrating evidence-based emotion regulation skills training with a scientifically validated treatment for PTSD called Prolonged Exposure (PE), will enhance PTSD treatment retention and 'dose received' and subsequently improve treatment outcomes for MST-related PTSD and difficulties with emotion regulation. Results from this project that examine the feasibility of integrating these two treatments will provide methodological evidence and justification for a randomized control trial, if warranted.
Read the detailed description
The purpose of this study is to learn ways to improve treatments for women with military sexual trauma (MST). The researchers want to learn whether combining evidence-based emotion regulation skills training with a trauma-focused therapy improves treatment outcomes. An evidence-based trauma treatment known as Prolonged Exposure will be used. Emotion regulation skills will also be included in treatment. Veterans with a positive or sub threshold diagnosis of PTSD who experienced a military sexual trauma (MST) will be included. Participants will complete up to twelve 90 minute sessions of PE with Dialectical Behavior Therapy (DBT) Emotion Regulation Skills Training followed by a post-treatment assessment. All aspects of the project including consent, baseline, treatment and follow-up will be completed either in person or via videoconferencing. Fifteen participants will be enrolled.
- Conditions
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Mental Disorder, Traumatic Stress Disorder
- Being tested
- PE+ER
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Mental Disorders, Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PE+ERBehavioural
PE includes the following components: a) psychoeducation about the common reactions to traumatic events and presentation of the treatment rationale b) repeated in vivo exposure to traumatic stimuli, c) repeated, prolonged, imaginal exposure to traumatic memories, and d) relapse prevention strategies and further treatment planning (session 12). DBT Emotion Regulation Skills is integrated as part of this intervention. DBT training provides skills to understand, name, experience and tolerate emotions, as well as skills to change negative emotional responses and to reduce vulnerability to emotion dysregulation (Linehan et al., 2015). The current project includes an adapted 3- session individual emotion regulation skills training intervention to be implemented concurrently with PE which consists of initial teaching/instruction and brief skills review for the remainder of PE treatment.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Exposure + Emotion Regulation Skills Training | Experimental | Twelve, 90-minute sessions of Prolonged Exposure (PE) with Dialectical Behavior Therapy (DBT) Emotion Regulation Skills Training. Receives: Behavioral: PE+ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Administrated PTSD Scale (CAPS)
The Clinician Administered PTSD (Posttraumatic stress disorder) Scale (CAPS) is a 30-item structured interview that corresponds to the Diagnostic and Statistical Manual of Mental Disorders, 5th Version (DSM-V) criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assesses symptoms over the past week. CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). A symptom cluster score may also be calculated for dissociation by summing items 19 and 20. Scores range from 0 to 80.
Measured: 13 weeks
Secondary outcomes (1)
PTSD Checklist, 5th Version (PCL-5)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including, monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Description information provided by the National Center for PTSD.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start16 Aug 2021
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia State University
- Responsible party
- Sponsor
- Investigators
- Wendy Muzzy, MRA, MLIS, Principal investigator, Medical University of South CarolinaAmanda Gilmore, PhD, Principal investigator, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792775
- Sponsor's protocol ID
- Pro00107912
- Acronym
- PE+ER
- Status last verified
- Feb 2024
- First submitted
- 8 Mar 2021
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTSD Treatment and Emotion Regulation Skills Training for Veterans With Military Sexual Trauma
- ClinicalTrials.gov ID
- NCT04792775
- Acronym / sponsor ID
- PE+ER / Pro00107912
- Conditions
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Mental Disorder, Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Georgia State University
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prior research has found that Veterans with military sexual trauma (MST) who have more difficulties with emotion regulation were more likely to drop out of PTSD treatment prematurely. The purpose of this pilot study is to determine whether integrating evidence-based emotion regulation skills training with a scientifically validated treatment for PTSD called Prolonged Exposure (PE), will enhance PTSD treatment retention and 'dose received' and subsequently improve treatment outcomes for MST-related PTSD and difficulties with emotion regulation. Results from this project that examine the feasibility of integrating these two treatments will provide methodological evidence and justification for a randomized control trial, if warranted.
Detailed description
The purpose of this study is to learn ways to improve treatments for women with military sexual trauma (MST). The researchers want to learn whether combining evidence-based emotion regulation skills training with a trauma-focused therapy improves treatment outcomes. An evidence-based trauma treatment known as Prolonged Exposure will be used. Emotion regulation skills will also be included in treatment. Veterans with a positive or sub threshold diagnosis of PTSD who experienced a military sexual trauma (MST) will be included. Participants will complete up to twelve 90 minute sessions of PE with Dialectical Behavior Therapy (DBT) Emotion Regulation Skills Training followed by a post-treatment assessment. All aspects of the project including consent, baseline, treatment and follow-up will be completed either in person or via videoconferencing. Fifteen participants will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure + Emotion Regulation Skills Training | Experimental | Behavioral: PE+ERTwelve, 90-minute sessions of Prolonged Exposure (PE) with Dialectical Behavior Therapy (DBT) Emotion Regulation Skills Training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- MST-related index event
- Diagnosis of PTSD related to MST assigned on the basis of the Clinician Administered PTSD Scale (CAPS; Weathers et al., 2013)
- Difficulties with emotion regulation as identified by the Difficulties with Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004; although there is no clinical cutoff for the DERS, a total score of 99 is indicative of one standard deviation above average difficulties with emotion regulation for women).
Key exclusion criteria (5 listed)
- Having a household member who is already enrolled in the study
- Active psychosis or dementia at screening
- Suicidal ideation with clear intent
- Current moderate to severe Substance Use Disorder
- Concurrent enrollment in a clinical trial for PTSD or depression.
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 |
|---|---|---|
| PE+ERPE includes the following components: a) psychoeducation about the common reactions to traumatic events and presentation of the treatment rationale b) repeated in vivo exposure to traumatic stimuli, c) repeated, prolonged, imaginal exposure to traumatic memories, and d) relapse prevention strategies and further treatment planning (session 12). DBT Emotion Regulation Skills is integrated as part of this intervention. DBT training provides skills to understand, name, experience and tolerate emotions, as well as skills to change negative emotional responses and to reduce vulnerability to emotion dysregulation (Linehan et al., 2015). The current project includes an adapted 3- session individual emotion regulation skills training intervention to be implemented concurrently with PE which consists of initial teaching/instruction and brief skills review for the remainder of PE treatment. | Behavioural | Prolonged Exposure + Emotion Regulation Skills Training |
Primary outcome
Clinical Administrated PTSD Scale (CAPS)
Time frame: 13 weeks
The Clinician Administered PTSD (Posttraumatic stress disorder) Scale (CAPS) is a 30-item structured interview that corresponds to the Diagnostic and Statistical Manual of Mental Disorders, 5th Version (DSM-V) criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assesses symptoms over the past week. CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). A symptom cluster score may also be calculated for dissociation by summing items 19 and 20. Scores range from 0 to 80.
1 secondary outcome
PTSD Checklist, 5th Version (PCL-5)
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Stress Disorders, Post-Traumatic
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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.
Wendy Muzzy, MRA, MLIS principal investigator
Medical University of South Carolina
Amanda Gilmore, PhD principal investigator
Georgia State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PE+ER in people with Stress Disorders, Post-Traumatic and Anxiety Disorders, run by Medical University of South Carolina 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 3 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 13 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Administrated PTSD Scale (CAPS) (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2024.