Anxiety Disorders, Mental Disorder, Stress Disorders, Post-Traumatic, Traumatic Disorder
Conditions
Brief 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'. 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.
Interventions
BEHAVIORALProlonged 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.
Sponsors
Charleston Research Institute
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participant Inclusion Criteria: 1. Adult male or female over the age of 18 that has served, or is currently serving in the military. 2. 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. 3. 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
1. Active psychosis or dementia at screening. 2. Suicidal ideation with clear intent. 3. Concurrent enrollment in another clinical trial for PTSD or depression. Peer Inclusion Criteria: 1. Adult male or female over the age of 18 that has served, or is currently serving, in the military. 2. Successful competition of exposure therapy treatment in the past and willingness to act as peer in the program. 3. PCL-5 score of 32 or lower. Peer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Administrated PTSD Scale (CAPS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist, 5th Version (PCL-5) | 13 weeks | 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. |
| Patient Health Questionnaire (PHQ-9) | 13 weeks | 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. |
| Combat Exposure Scale (CES) | Baseline | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 55 |
| 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. | 54 |
| Total | 109 |
Baseline characteristics
| Characteristic | PE+Exposure Workout Buddy | Total | PE+Peer General Support |
|---|---|---|---|
| Age, Continuous | 43.6 years | 43.9 years | 44.2 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 7 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 101 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants | 53 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 47 Participants | 29 Participants |
| Region of Enrollment United States | 55 Participants | 109 Participants | 54 Participants |
| Sex: Female, Male Female | 36 Participants | 68 Participants | 32 Participants |
| Sex: Female, Male Male | 19 Participants | 41 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 55 | 0 / 54 |
| other Total, other adverse events | 0 / 55 | 0 / 54 |
| serious Total, serious adverse events | 0 / 55 | 0 / 54 |
Outcome results
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.
Time frame: 36 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PE+Exposure Workout Buddy | Clinical Administrated PTSD Scale (CAPS) | 25.44 score on a scale | Standard Deviation 11.966 |
| PE+Peer General Support | Clinical Administrated PTSD Scale (CAPS) | 24.44 score on a scale | Standard Deviation 11.389 |
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.
Time frame: Baseline
Population: Over number of participants here vary slightly from the rest of the participant flow due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PE+Exposure Workout Buddy | Combat Exposure Scale (CES) | 4.1132 units on a scale | Standard Deviation 5.97965 |
| PE+Peer General Support | Combat Exposure Scale (CES) | 5.2400 units on a scale | Standard Deviation 6.60723 |
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.
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PE+Exposure Workout Buddy | Patient Health Questionnaire (PHQ-9) | 11.2105 score on a scale | Standard Deviation 6.07833 |
| PE+Peer General Support | Patient Health Questionnaire (PHQ-9) | 11.5292 score on a scale | Standard Deviation 5.83646 |
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.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PE+Exposure Workout Buddy | Patient Health Questionnaire (PHQ-9) | 12.0063 score on a scale | Standard Deviation 5.36715 |
| PE+Peer General Support | Patient Health Questionnaire (PHQ-9) | 11.1333 score on a scale | Standard Deviation 5.98522 |
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.
Time frame: 36 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PE+Exposure Workout Buddy | Patient Health Questionnaire (PHQ-9) | 12.5554 score on a scale | Standard Deviation 5.17738 |
| PE+Peer General Support | Patient Health Questionnaire (PHQ-9) | 12.2859 score on a scale | Standard Deviation 6.03785 |
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.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PE+Exposure Workout Buddy | PTSD Checklist, 5th Version (PCL-5) | 36.7449 score on a scale | Standard Deviation 16.73793 |
| PE+Peer General Support | PTSD Checklist, 5th Version (PCL-5) | 34.8181 score on a scale | Standard Deviation 16.5316 |
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.
Time frame: 36 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PE+Exposure Workout Buddy | PTSD Checklist, 5th Version (PCL-5) | 40.2105 score on a scale | Standard Deviation 15.47735 |
| PE+Peer General Support | PTSD Checklist, 5th Version (PCL-5) | 37.1678 score on a scale | Standard Deviation 17.18023 |
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.
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PE+Exposure Workout Buddy | PTSD Checklist, 5th Version (PCL-5) | 32.1335 score on a scale | Standard Deviation 18.77834 |
| PE+Peer General Support | PTSD Checklist, 5th Version (PCL-5) | 34.8677 score on a scale | Standard Deviation 18.55918 |