Telemental Health and Cognitive Processing Therapy for Rural Combat Veterans With PTSD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Posttraumatic Stress Disorder
- Sponsor
- US Department of Veterans Affairs
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •diagnosis of current combat related PTSD determined by the Clinician Administered PSTD Scale (CAPS-IV)
- •participants taking psychoactive medications have to have a stable regimen for at least 45 days prior to study entry
Exclusion Criteria
- •active psychotic symptoms/disorder as determined by the SCID for DSM-IV
- •active homicidal or suicidal ideation as determined by the structured clinical interview
- •any significant cognitive impairment or history of Organic Mental Disorder as determined by the structured clinical interview
- •active (current) substance dependence as determined by the SCID (lifetime substance dependence/abuse not excluded)
- •unwillingness to refrain from substance abuse during treatment
- •female veterans
Outcomes
Primary Outcomes
Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)
Time Frame: 6 months post-treatment
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.