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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Cognitive Processing Therapy Group Videoteleconference
* Behavioral: Cognitive Processing Therapy Group In-Person


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Videoteleconferencing CPT<br>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. | Behavioral: Cognitive Processing Therapy Group Videoteleconference<br>* Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.<br>* Other names: CPT-VT;|
| Active Comparator: Face-to-Face CPT<br>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. | Behavioral: Cognitive Processing Therapy Group In-Person<br>* Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.<br>* Other names: CPT-NP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale, for DSM-IV (CAPS IV) | The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. post-treatment CAPS score assessed at two-weeks following end of treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improvement) over time. | Post-treatment (two-weeks following end of treatment) | 
| Clinician Administered PTSD Scale, for DSM-IV (CAPS IV) | The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. 3-month post-treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improvement) over time. | 3-month Post-treatment | 
| Clinician Administered PTSD Scale, for DSM-IV (CAPS IV) | The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. 6-month post-treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improve) over time. | 6 months post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive processing therapy, combat, veterans, PTSD, Telemental Health, Videoteleconference, outcome, Rural, Remote, CPT, VTC