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

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362477
• Other study ID #: W81XWH-10-1-1037
• Secondary ID: PT090552
• Status: Completed
• Phase: Phase 3
• First received: February 4, 2015
• Last updated: February 9, 2015
• Start date: September 2010
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: VA Pacific Islands Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Cognitive Processing Therapy in-person
Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, in-person.
• Cognitive Processing Therapy through videoteleconference
Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, through videoteleconference.

Locations

Country	Name	City	State
United States	VA Pacific Islands Healthcare System	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
VA Pacific Islands Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale (CAPS-IV)		6 months post-treatment	No