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

VA Pacific Islands Health Care System

Status and phase: Completed; Phase 3

Conditions: Posttraumatic Stress Disorder

Treatments: Behavioral: Cognitive Processing Therapy through videoteleconference; Behavioral: Cognitive Processing Therapy in-person

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02362477

W81XWH-10-1-1037

PT090552 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 126 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Control CPT

Active Comparator group

Description:

'Cognitive Processing Therapy in-person. Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, in-person.

Treatment:

Behavioral: Cognitive Processing Therapy in-person

Experimental CPT via VTC

Experimental group

Description:

'Cognitive Processing Therapy through videoteleconference. Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, through videoteleconference.

Treatment:

Behavioral: Cognitive Processing Therapy through videoteleconference