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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00879255
Study type Interventional
Source VA Office of Research and Development
Contact
Status Completed
Phase Phase 3
Start date October 2008
Completion date June 2014

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