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

US Department of Veterans Affairs (VA)

Status and phase: Completed; Phase 3

Conditions: Posttraumatic Stress Disorder

Treatments: Behavioral: Cognitive Processing Therapy Group Videoteleconference; Behavioral: Cognitive Processing Therapy Group In-Person

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00879255

DHI 07-259

PT074516 (Other Grant/Funding Number)

2008-05_LM_Promise 0005 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 2 patient groups

Videoteleconferencing CPT

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Processing Therapy Group Videoteleconference

Face-to-Face CPT

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cognitive Processing Therapy Group In-Person