Stress Disorders, Post-TraumaticPEPNCT03485391
Peer Social Support During In Vivo Exposure for PTSD
A study testing Prolonged Exposure 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
Veterans who have prematurely dropped out of exposure therapy for PTSD will be contacted and offered the opportunity to return to treatment, this time with the assistance of an in vivo exposure therapy 'workout buddy'. 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?
- Prolonged Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 31 May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Participant Inclusion Criteria:
- Adult male or female over the age of 18 that has served, or is currently serving in the military.
- Either diagnosis of PTSD as determined by a Clinician Administered PTSD Scale for DSM-5 (CAPS-5) clinical interview or CAPS-5 severity ≥ 25, and a PCL-5 score of ≥25.
- Attempted PE treatment in the past, but did not complete treatment (defined as dropping out from treatment or refusal to engage in in vivo exposure assignments) OR identified as "at-risk" of dropping out of current exposure therapy treatment (defined as failure to complete 3 sessions of therapy within any 6 week period or verbally indicating that they are not comfortable with the exposure activities).
Participant Exclusion Criteria:
- Active psychosis or dementia at screening.
- Suicidal ideation with clear intent.
- Concurrent enrollment in another clinical trial for PTSD or depression.
Peer Inclusion Criteria:
- Adult male or female over the age of 18 that has served, or is currently serving, in the military.
- Successful competition of exposure therapy treatment in the past and willingness to act as peer in the program.
- PCL-5 score of 32 or lower.
Peer Exclusion Criteria:
- Active psychosis or dementia at screening.
- Suicidal ideation with clear intent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, 29401
About this study
Official title: Peer Social Support During In Vivo Exposure for PTSD: A Program to Address Dropout From Prolonged Exposure
Veterans who have prematurely dropped out of exposure therapy for PTSD will be contacted and offered the opportunity to return to treatment, this time with the assistance of an in vivo exposure therapy 'workout buddy'. This peer will meet them at the in vivo exposure therapy location and offer support an encouragement while the patient remains in that location. As the PTSD treatment standards in Charleston and other VA sites across the country increasingly include telemedicine delivered care, both in person and telemedicine based exposure therapy recipients will be included. There will be no randomization; all participants will receive the peer support 'workout buddy' for exposure therapy assignments.
Read the detailed description
Veterans (participants and peers) with PTSD will be recruited from the Charleston VA Medical Center catchment area. Participants will have been assigned to exposure therapy for PTSD and either started treatment, or dropped out before treatment; peers will have successfully completed exposure therapy for PTSD. Those eligible to participate will also include Veterans who are identified as "at-risk" of dropping out, Veterans who are uncomfortable completing in vivo exposure activities, and those who may have PTSD symptoms, but at the sub-threshold level. Participants will receive 8-12 weekly sessions of exposure therapy treatment with assistance of a PE Peer. Half of subjects will be randomized to the PE+Workout Buddy condition, where they will complete treatment with the assistance of a Veteran who will meet them at least once per week for in vivo exposure therapy assignments, for 3-4 weeks at the beginning of treatment. Half of subjects will be randomized to the PE+General Support condition, where they will complete treatment with the assistance of a Veteran who will call them via telephone once per week to encourage session attendance and ask about treatment progress, life stresses, etc. General support peers will also meeting Veterans 2-4 times per month to check in about treatment progress. All participants and peers will be consented. Participants will be assessed at baseline, post-treatment, and 3- \& 6-month follow-up.
- Being tested
- Prolonged Exposure
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Mental Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged ExposureBehavioural
Practice guidelines have identified that trauma-focused psychotherapies have most evidence for treatment PTSD. Prolonged Exposure (PE) is one type of trauma-focused psychotherapy. PE teaches you to gradually approach trauma-related memories, feelings, and situations that you have been avoiding since your trauma. By confronting these challenges, you can decrease your PTSD symptoms. Treatment will last anywhere from 8-12 weeks for 75-90 minutes, once per week.
| Study group | Role | What they receive |
|---|---|---|
| PE+Exposure Workout Buddy | Experimental | Prolonged Exposure with assistance of Veteran who has successfully completed treatment to meet patients at exposure sites in the community to offer support during exposure. Receives: Behavioral: Prolonged Exposure |
| PE+Peer General Support | Active comparator | Prolonged Exposure with assistance of Veteran who has successfully completed treatment to call and talk to patients once per week, informally meet at patient appointments, encourage session attendance and check in about progress. Receives: Behavioral: Prolonged Exposure |
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, with higher scores indicating worse outcomes.
Measured: 36 weeks
Secondary outcomes (7)
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. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items (ranging from 0-4 per item). Higher scores indicate worse outcomes.
Measured: 13 weeks
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. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items (ranging from 0-4 per item). Higher scores indicate worse outcomes.
Measured: 24 weeks
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. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items (ranging from 0-4 per item). Higher scores indicate worse outcomes.
Measured: 36 weeks
Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire -9 is widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron, Crawford, et al, 2008), and is correlated strongly with other depression measures. Its 9 items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. A total severity score (range - 0-27) can be obtained by summing the scores for each of the 9 items (ranging from 0-3 per item). Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. Higher scores indicate worse outcomes.
Measured: 13 weeks
Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire -9 is widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron, Crawford, et al, 2008), and is correlated strongly with other depression measures. Its 9 items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. A total severity score (range - 0-27) can be obtained by summing the scores for each of the 9 items (ranging from 0-3 per item). Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. Higher scores indicate worse outcomes.
Measured: 24 weeks
Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire -9 is widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron, Crawford, et al, 2008), and is correlated strongly with other depression measures. Its 9 items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. A total severity score (range - 0-27) can be obtained by summing the scores for each of the 9 items (ranging from 0-3 per item). Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. Higher scores indicate worse outcomes.
Measured: 36 weeks
Combat Exposure Scale (CES)
The Combat Exposure Scale (CES) is a 7-item self-report measure that assesses wartime stressors experienced by combatants. Items are rated on a 5-point frequency (1 = "no" or "never" to 5 = "more than 50 times"), 5-point duration (1 = "never" to 5 = "more than 6 months"), 4-point frequency (1 = "no" to 4 = "more than 12 times") or 4-point degree of loss (1 = "no one" to 4 = "more than 50%") scale. Scores for each item are converted and then summed to obtain a total score. Total scores (of the converted items) range from 0 to 41, with lower scores indicating 'light' exposure and higher scores indicating 'heavy' exposure.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start1 May 2018
- Primary completion3 Mar 2023
- Study completion31 May 2023
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Charleston Research Institute
- Responsible party
- Sponsor
- Investigators
- Wendy Muzzy, MRA, MLIS, Principal investigator, Medical University of South CarolinaRon Acierno, PhD, Principal investigator, Ralph H. Johnson VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485391
- Sponsor's protocol ID
- Pro00075914
- Other IDs
- W81XWH-18-1-0081
- Acronym
- PEP
- Status last verified
- Aug 2024
- First submitted
- 7 Mar 2018
- Last updated
- 16 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hernandez-Tejada MA, Muzzy W, Price M, Hamski S, Hart S, Foa E, Acierno R. Peer support during in vivo exposure homework to reverse attrition from prolonged exposure therapy for posttraumatic stress disorder (PTSD): description of a randomized controlled trial. Trials. 2020 Apr 28;21(1):366. doi: 10.1186/s13063-020-04302-5.
PubMed 32345329
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Social Support During In Vivo Exposure for PTSD: A Program to Address Dropout From Prolonged Exposure
- ClinicalTrials.gov ID
- NCT03485391
- Acronym / sponsor ID
- PEP / Pro00075914
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Charleston Research Institute
- Study start
- 1 May 2018 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Posted 16 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Veterans who have prematurely dropped out of exposure therapy for PTSD will be contacted and offered the opportunity to return to treatment, this time with the assistance of an in vivo exposure therapy 'workout buddy'. This peer will meet them at the in vivo exposure therapy location and offer support an encouragement while the patient remains in that location. As the PTSD treatment standards in Charleston and other VA sites across the country increasingly include telemedicine delivered care, both in person and telemedicine based exposure therapy recipients will be included. There will be no randomization; all participants will receive the peer support 'workout buddy' for exposure therapy assignments.
Detailed description
Veterans (participants and peers) with PTSD will be recruited from the Charleston VA Medical Center catchment area. Participants will have been assigned to exposure therapy for PTSD and either started treatment, or dropped out before treatment; peers will have successfully completed exposure therapy for PTSD. Those eligible to participate will also include Veterans who are identified as "at-risk" of dropping out, Veterans who are uncomfortable completing in vivo exposure activities, and those who may have PTSD symptoms, but at the sub-threshold level. Participants will receive 8-12 weekly sessions of exposure therapy treatment with assistance of a PE Peer. Half of subjects will be randomized to the PE+Workout Buddy condition, where they will complete treatment with the assistance of a Veteran who will meet them at least once per week for in vivo exposure therapy assignments, for 3-4 weeks at the beginning of treatment. Half of subjects will be randomized to the PE+General Support condition, where they will complete treatment with the assistance of a Veteran who will call them via telephone once per week to encourage session attendance and ask about treatment progress, life stresses, etc. General support peers will also meeting Veterans 2-4 times per month to check in about treatment progress. All participants and peers will be consented. Participants will be assessed at baseline, post-treatment, and 3- \& 6-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PE+Exposure Workout Buddy | Experimental | Behavioral: Prolonged ExposureProlonged Exposure with assistance of Veteran who has successfully completed treatment to meet patients at exposure sites in the community to offer support during exposure. |
| PE+Peer General Support | Active comparator | Behavioral: Prolonged ExposureProlonged Exposure with assistance of Veteran who has successfully completed treatment to call and talk to patients once per week, informally meet at patient appointments, encourage session attendance and check in about progress. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Prolonged ExposurePractice guidelines have identified that trauma-focused psychotherapies have most evidence for treatment PTSD. Prolonged Exposure (PE) is one type of trauma-focused psychotherapy. PE teaches you to gradually approach trauma-related memories, feelings, and situations that you have been avoiding since your trauma. By confronting these challenges, you can decrease your PTSD symptoms. Treatment will last anywhere from 8-12 weeks for 75-90 minutes, once per week. | Behavioural | PE+Exposure Workout Buddy, PE+Peer General Support |
Primary outcome
Clinical Administrated PTSD Scale (CAPS)
Time frame: 36 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, with higher scores indicating worse outcomes.
7 secondary outcomes
PTSD Checklist, 5th Version (PCL-5)
Time frame: 13 weeks
PTSD Checklist, 5th Version (PCL-5)
Time frame: 24 weeks
PTSD Checklist, 5th Version (PCL-5)
Time frame: 36 weeks
Patient Health Questionnaire (PHQ-9)
Time frame: 13 weeks
Patient Health Questionnaire (PHQ-9)
Time frame: 24 weeks
Patient Health Questionnaire (PHQ-9)
Time frame: 36 weeks
Combat Exposure Scale (CES)
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32345329Hernandez-Tejada MA, Muzzy W, Price M, Hamski S, Hart S, Foa E, Acierno R. Peer support during in vivo exposure homework to reverse attrition from prolonged exposure therapy for posttraumatic stress disorder (PTSD): description of a randomized controlled trial. Trials. 2020 Apr 28;21(1):366. doi: 10.1186/s13063-020-04302-5.
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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.
Wendy Muzzy, MRA, MLIS principal investigator
Medical University of South Carolina
Ron Acierno, PhD principal investigator
Ralph H. Johnson VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure 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?
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 16 Aug 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?
Yes. Results are posted in the registry (first posted 16 Aug 2024). 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?
Clinical Administrated PTSD Scale (CAPS) (time frame: 36 weeks). 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 NCT03485391, 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 16 Aug 2024.