Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD

Study Overview
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Brief Summary
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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 to female rural veterans, Reservists, National Guardsmen, and civilians suffering with PTSD. This study is an expansion, seeking to add a treatment arm of women, to an already CDMRP-funded study that completed in July 2014 treating male combat veterans with military-related PTSD. The long-term objective of this project is to disseminate an empirically sound TMH PTSD protocol for male and female veterans, Reserve and Guard that will extend the use of CPT to remote rural sites. It is hypothesized that using VTC, will be as effective as the in-person mode of service delivery for providing CPT.

Detailed Description
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This expansion is a 4-year RCT, plus a 1 year no-cost extension, which provides a direct comparison of the VTC and in-person modalities using rigorous methodology and a sophisticated analysis of treatment equivalency in clinical and process outcome domains. Outcome domains include clinical and process outcomes. Approximately 154 female veterans, Reservists, National Guardsmen, or civilians with PTSD have been recruited from multiple VA clinical sites and community health centers (for N=110 completers). Consistent with the male combat veterans CPT study, prospective participants received a comprehensive assessment battery 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 is delivered up to twice a week for up to 12 weeks by a doctoral level psychologist. Quality control procedures have been incorporated into the study's design to ensure integrity, fidelity and standard administration of the CPT intervention across both conditions. It is expected that the results from this project can be applied to other VA and military locations, where similar specialized PTSD clinical services are needed but unavailable due to geographic barriers.

Official Title
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Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Cognitive Processing Therapy in-person
* Behavioral: Cognitive Processing Therapy through videoteleconference


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of current PTSD established by the Clinician-Administered PTSD Scale (CAPS) and a stable psychotropic medication regimen for a minimum of 45 days prior to study entry for those taking such medications. Exclusion Criteria: significant cognitive impairment or history of organic mental disorder, active psychotic symptoms/disorder, active homicidal or suicidal ideation, current substance dependence, and unwillingness to refrain from substance abuse during treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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 |
| --- | --- |
| Active Comparator: Control CPT<br>'Cognitive Processing Therapy in-person. Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, in-person. | Behavioral: Cognitive Processing Therapy in-person<br>* Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, in-person.<br>* Other names: CPT-NP;|
| Experimental: Experimental CPT via VTC<br>'Cognitive Processing Therapy through videoteleconference. Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, through videoteleconference. | Behavioral: Cognitive Processing Therapy through videoteleconference<br>* Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, through videoteleconference.<br>* Other names: CPT-VTC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale (CAPS-IV) |  | 6 months post-treatment |