A Phase 3 interventional study of Cognitive Processing Therapy Group Videoteleconference and Cognitive Processing Therapy Group In-Person in Posttraumatic Stress Disorder, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-12.
Sponsored by US Department of Veterans Affairs · Phase 3, Interventional, and Treatment
The immediate objective of this project was to evaluate the clinical effectiveness of a telemental health modality (video-teleconferencing) for providing an evidence-based group intervention (Cognitive Processing Therapy; CPT) to rural OIF/OEF Reservists, National Guardsmen, and veterans suffering with PTSD.
The project was a 5-year prospective randomized clinical trial which conducted a direct comparison of the VTC and in-person modalities using rigorous methodology and a sophisticated analysis of equivalency between clinical and process outcome domains. In addition, cost effectiveness of this modality will be addressed. Approximately 130 combat Reservists, National Guardsmen, or veterans were recruited from multiple clinical sites. Prospective participants received a comprehensive assessment at baseline to determine eligibility. The exclusion criteria selected are consistent with large PTSD randomized clinical trials as well as research using the CPT protocol with military populations with PTSD. The treatment was delivered twice a week over 6 weeks by a doctoral level psychologist. Quality control procedures were incorporated into the study's design to ensure integrity, fidelity and standard administration of the CPT intervention across both conditions. Participants received additional assessments at mid-treatment, immediately post-treatment, and at 3 and 6 months post-treatment. Outcome domains include: 1) clinical outcomes (symptom severity, social functioning); 2) process outcomes (perception of treatment, satisfaction, group therapy alliance, treatment compliance, and attrition and treatment credibility); and (3) cost-effectiveness outcomes.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 125 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality. Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.
Behavioral: Cognitive Processing Therapy Group Videoteleconference
The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality. Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.
Behavioral: Cognitive Processing Therapy Group In-Person
Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.
Also known as: CPT-VT
Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.
Also known as: CPT-NP
Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)
The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. post-treatment CAPS score assessed at two-weeks following end of treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improvement) over time.
Time frame: Post-treatment (two-weeks following end of treatment)
Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)
The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. 3-month post-treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improvement) over time.
Time frame: 3-month Post-treatment
Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)
The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. 6-month post-treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improve) over time.
Time frame: 6 months post-treatment
This study included 13 group cohorts plus 1 pilot group cohort. Not counting the cohort 1 pilot, approximately 246 combat Reservists, National Guardsmen, or Veterans from multiple VA Pacific Island Health Care System clinical sites were assessed for eligibility, and 125 were subsequently randomized into treatment groups.
| Milestone | Videoteleconferencing CPT | Face-to-Face CPT |
|---|---|---|
| Started | 61 | 64 |
| Received allocated intervention: | 51 | 56 |
| Completed posttreatment follow-up | 50 | 55 |
| Completed 3-mo follow-up | 48 | 49 |
| Completed | 45 | 45 |
| Not completed | 16 | 19 |
The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. post-treatment CAPS score assessed at two-weeks following end of treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improvement) over time.
| units on a scale | Videoteleconferencing CPT | Face-to-Face CPT |
|---|---|---|
| Clinician Administered PTSD Scale, for DSM-IV (CAPS IV) | -15.97 ± 3.21 | -11.22 ± 2.89 |
The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. 3-month post-treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improvement) over time.
| units on a scale | Videoteleconferencing CPT | Face-to-Face CPT |
|---|---|---|
| Clinician Administered PTSD Scale, for DSM-IV (CAPS IV) | -14.22 ± 3.72 | -9.46 ± 3.32 |
The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. 6-month post-treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improve) over time.
| units on a scale | Videoteleconferencing CPT | Face-to-Face CPT |
|---|---|---|
| Clinician Administered PTSD Scale, for DSM-IV (CAPS IV) | -15.17 ± 3.52 | -9.61 ± 3.29 |
Collected over The study was monitored for adverse events from 2009 to 2013.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Videoteleconferencing CPT | — | 0/61 (0%) | 0/61 (0%) |
| Face-to-Face CPT | — | 0/64 (0%) | 0/64 (0%) |
Male combat veterans with posttraumatic stress disorder (PTSD).
| Age, Continuous(years) | Videoteleconferencing CPT | Face-to-Face CPT | Total |
|---|---|---|---|
| Mean | 56.1 ± 11.8 | 54.6 ± 13.2 | 55.3 ± 12.5 |
| Sex: Female, Male(Participants) | Videoteleconferencing CPT | Face-to-Face CPT | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 61 | 64 | 125 |
| Region of Enrollment(participants) | Videoteleconferencing CPT | Face-to-Face CPT | Total |
|---|---|---|---|
| United States | 61 | 64 | 125 |
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