Telemental Health and Cognitive Processing Therapy for Rural Combat Veterans With Posttraumatic Stress Disorder (PTSD) (CPT V-Tel)

• PCL-M, CAPS (symptom severity) [ Time Frame: Baseline, mid-treament, post-treament, and 3 and 6 months post-treatment ] [ Designated as safety issue: No ]
• SAI, QOLI (social functioning) [ Time Frame: Baseline, mid-treament, post-treament, and 3 and 6 months post-treatment ] [ Designated as safety issue: No ]

• CAPS (symptom severity) [ Time Frame: Baseline, mid-treatment, post-treatment, and 3 and 6 months post-treatment ] [ Designated as safety issue: No ]
• PCL-M (PTSD checklist) [ Time Frame: Baseline, mid-treatment, post-treatment, and 3 and 6 months post-treatment ] [ Designated as safety issue: No ]
• QOLI (social functioning) [ Time Frame: Baseline, mid-treatment, post-treatment, and 3 and 6 months post-treatment ] [ Designated as safety issue: No ]

• CAPS (symptom severity) [ Time Frame: Baseline, mid-treament, post-treament, and 3 and 6 months post-treatment ] [ Designated as safety issue: No ]
• SAI [ Time Frame: Baseline, mid-treament, post-treament, and 3 and 6 months post-treatment ] [ Designated as safety issue: No ]
• QOLI (social functioning) [ Time Frame: Baseline, mid-treament, post-treament, and 3 and 6 months post-treatment ] [ Designated as safety issue: No ]

The immediate objective of this project is 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.

The proposed project is a 5-year prospective randomized clinical trial which conducts 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 will be recruited from multiple clinical sites. Prospective participants will receive 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 will be delivered twice a week over 6 weeks by a doctoral level psychologist. Quality control procedures will be incorporated into the study's design to ensure integrity, fidelity and standard administration of the CPT intervention across both conditions. Participants will receive 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.

• Behavioral: Cognitive Processing Group Therapy Through Videoteleconference
  Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.
  Other Name: CPT-VT
• Behavioral: Cognitive Processing Group Therapy In-Person
  Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.
  Other Name: CPT-NP

• Active Comparator: Arm 1
  Cognitive Processing Group Therapy provided in-person
  Intervention: Behavioral: Cognitive Processing Group Therapy In-Person
• Experimental: Arm 2
  Cognitive Processing Group Therapy provided through videoteleconference technology.
  Intervention: Behavioral: Cognitive Processing Group Therapy Through Videoteleconference

• Morland LA, Greene CJ, Rosen C, Mauldin PD, Frueh BC. Issues in the design of a randomized noninferiority clinical trial of telemental health psychotherapy for rural combat veterans with PTSD. Contemp Clin Trials. 2009 Nov;30(6):513-22. Epub 2009 Jul 1.
• Morland LA, Hynes AK, Mackintosh MA, Resick PA, Chard KM. Group cognitive processing therapy delivered to veterans via telehealth: a pilot cohort. J Trauma Stress. 2011 Aug;24(4):465-9. doi: 10.1002/jts.20661. Epub 2011 Jul 25.

Inclusion Criteria:

• diagnosis of current combat related PTSD determined by the Clinician Administered PSTD Scale (CAPS-1)
• 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