An interventional study of Prolonged Exposure in Stress Disorders, Post-Traumatic, Anxiety Disorders and Mental Disorder, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-16.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
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Among 45 studies in Stress Disorders, Post-Traumatic by Medical University of South Carolina — 11 open to participants now, 14 under way, none of them phase 3. Stress Disorders, Post-Traumatic · Medical University of South Carolina.
Among the 45 studies in Stress Disorders, Post-Traumatic by Medical University of South Carolina, this one is the 21st largest by enrollment of the 44 interventional ones that give a count, is one of 2 that started in 2018, is one of 31 with no phase, and was the 20th registered.
2,683 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
Browse Stress Disorders, Post-Traumatic studies →11 of the 45 studies in Stress Disorders, Post-Traumatic by Medical University of South Carolina are open now, in 1 country. Recruiting first, the newest first:
Medical University of South Carolina · Sites in United States
Ages 18+
Medical University of South Carolina · Sites in United States
Ages 18+
Medical University of South Carolina · Sites in United States
Ages 18+ · Healthy volunteers
Medical University of South Carolina · Sites in United States
Ages 7–18
Medical University of South Carolina · Sites in United States
Ages 18–70
By country, each count listing its studies:
Of the 416 Stress Disorders, Post-Traumatic studies recruiting now, 186 (45%) set no upper age limit and 204 (49%) stop at 75 or younger; 63 take children under 18; 89 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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45 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 10 · Phase 4 1
First in 1997; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 109 is above the median of 69 across 2,197 interventional studies indexed under Stress Disorders, Post-Traumatic.
Median enrollment 95 across the 44 interventional studies, 197 across the 1 observational. Of the 29 that completed or were terminated, 13 (45%) have results posted.
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Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 165 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
4 of the studies in Stress Disorders, Post-Traumatic by Medical University of South Carolina that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05384223Medical University of South CarolinaEvaluation of RRFT for Co-occurring SUD and PTSD Among Teens | 2027-02-28 |
| NCT05497115Medical University of South CarolinaTesting a Scalable Model of Care to Improve Patients Access to Mental Health Services After Traumatic Injury | 2027-03-31 |
| NCT06641115Medical University of South CarolinaIntegrated Treatment for Opioid Use Disorder and PTSD | 2027-08 |
| NCT05086757Medical University of South CarolinaEvaluation of Trauma Center-Based Intervention for Adolescent Traumatic Injury Survivors | 2027-08-30 |
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Among the 45 studies in Stress Disorders, Post-Traumatic by Medical University of South Carolina, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Participant Inclusion Criteria:
Participant Exclusion Criteria:
Peer Inclusion Criteria:
Peer Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Prolonged Exposure
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.
Behavioral: Prolonged Exposure
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.
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.
Time frame: 36 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
| Milestone | PE+Exposure Workout Buddy | PE+Peer General Support |
|---|---|---|
| Started | 55 | 54 |
| Completed | 38 | 34 |
| Not completed | 17 | 20 |
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.
| score on a scale | PE+Exposure Workout Buddy | PE+Peer General Support |
|---|---|---|
| Clinical Administrated PTSD Scale (CAPS) | 25.44 ± 11.966 | 24.44 ± 11.389 |
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.
| score on a scale | PE+Exposure Workout Buddy | PE+Peer General Support |
|---|---|---|
| PTSD Checklist, 5th Version (PCL-5) | 32.1335 ± 18.77834 | 34.8677 ± 18.55918 |
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.
| score on a scale | PE+Exposure Workout Buddy | PE+Peer General Support |
|---|---|---|
| PTSD Checklist, 5th Version (PCL-5) | 36.7449 ± 16.73793 | 34.8181 ± 16.53160 |
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.
| score on a scale | PE+Exposure Workout Buddy | PE+Peer General Support |
|---|---|---|
| PTSD Checklist, 5th Version (PCL-5) | 40.2105 ± 15.47735 | 37.1678 ± 17.18023 |
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.
| score on a scale | PE+Exposure Workout Buddy | PE+Peer General Support |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) | 11.2105 ± 6.07833 | 11.5292 ± 5.83646 |
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.
| score on a scale | PE+Exposure Workout Buddy | PE+Peer General Support |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) | 12.0063 ± 5.36715 | 11.1333 ± 5.98522 |
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.
| score on a scale | PE+Exposure Workout Buddy | PE+Peer General Support |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) | 12.5554 ± 5.17738 | 12.2859 ± 6.03785 |
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.
| units on a scale | PE+Exposure Workout Buddy | PE+Peer General Support |
|---|---|---|
| Combat Exposure Scale (CES) | 4.1132 ± 5.97965 | 5.2400 ± 6.60723 |
Collected over Adverse event data collection started at baseline and progressed through treatment all the way to 6 month post treatment follow up. This time frame was 9 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PE+Exposure Workout Buddy | 1/55 (1.8%) | 0/55 (0%) | 0/55 (0%) |
| PE+Peer General Support | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) |
Participants were 109 Veterans aged 18 and over who were recruited from a southeastern Veterans Affairs Health Care System and its satellite Community Based Outpatient Clinics.
| Age, Continuous(years) | PE+Exposure Workout Buddy | PE+Peer General Support | Total |
|---|---|---|---|
| Mean | 43.6 (20 to 65) | 44.2 (22 to 74) | 43.9 (20 to 74) |
| Sex: Female, Male(Participants) | PE+Exposure Workout Buddy | PE+Peer General Support | Total |
|---|---|---|---|
| Female | 36 | 32 | 68 |
| Male | 19 | 22 | 41 |
| Ethnicity (NIH/OMB)(Participants) | PE+Exposure Workout Buddy | PE+Peer General Support | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 1 | 7 |
| Not Hispanic or Latino | 49 | 52 | 101 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | PE+Exposure Workout Buddy | PE+Peer General Support | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 31 | 22 | 53 |
| White | 18 | 29 | 47 |
| More than one race | 5 | 2 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | PE+Exposure Workout Buddy | PE+Peer General Support | Total |
|---|---|---|---|
| United States | 55 | 54 | 109 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2018 to primary completion in Mar 2023, 58 months.
Results were first posted in Aug 2024, 1 year 5 months after primary completion.
Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 58 months is above that.
Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic →
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