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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Cognitive Processing Therapy Group Videoteleconference | Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, 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, 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.