Clinical Trials Directory

Trials / Completed

CompletedNCT00879255

Telemental Health and Cognitive Processing Therapy for Rural Combat Veterans With Posttraumatic Stress Disorder

Telemental Health and Cognitive Processing Therapy for Rural Combat Veterans With PTSD

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
125 (actual)
Sponsor
US Department of Veterans Affairs · Federal
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive Processing Therapy Group VideoteleconferenceCognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.
BEHAVIORALCognitive Processing Therapy Group In-PersonCognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.

Timeline

Start date
2008-10-01
Primary completion
2013-09-01
Completion
2014-06-01
First posted
2009-04-09
Last updated
2015-05-12
Results posted
2015-03-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00879255. Inclusion in this directory is not an endorsement.