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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-18-1-0081 | Other Grant/Funding Number | U.S. Army Medical Research and Materiel Command |
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| Name | Class |
|---|---|
| Charleston Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged Exposure | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Participant Inclusion Criteria:
Participant Exclusion Criteria:
Peer Inclusion Criteria:
Peer Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Muzzy, MRA, MLIS | Medical University of South Carolina | Principal Investigator |
| Ron Acierno, PhD | Ralph H. Johnson VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ralph H. Johnson VA Medical Center | Charleston | South Carolina | 29401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32345329 | Derived | 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. |
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Specific inclusion criterion for patient-participants was a current diagnosis of PTSD as determined by the Clinician Administered PTSD Scale 5 (CAPS-5) or a CAPS-5 severity score ≥ 25, and a PTSD Checklist 5 (PCL-5) score of ≥ 25. Specific exclusion criteria were active psychosis or dementia, suicidal ideation with clear intent, and/or concurrent enrollment in another trial for PTSD or depression treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | PE+Exposure Workout Buddy | 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. 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. |
| FG001 | PE+Peer General Support | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | PE+Exposure Workout Buddy | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 36 weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PE+Exposure Workout Buddy | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Hart | Ralph H. Johnson VA Health Care System | 843-577-5011 | 205103 | Stephanie.Hart4@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2020 | Dec 5, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| 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. | 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. | 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. | 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. | 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. | 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. | Baseline |
| BG001 | PE+Peer General Support | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | PE+Peer General Support | 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. 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. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 13 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 36 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 13 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 36 weeks |
|
|
|
| Secondary | 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. | Over number of participants here vary slightly from the rest of the participant flow due to missing data. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| 1 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | PE+Peer General Support | 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. 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. | 0 | 54 | 0 | 54 | 0 | 54 |
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