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

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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Cognitive Processing Therapy in-person; Behavioral: Cognitive Processing Therapy through videoteleconference

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • VA Pacific Islands Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control CPT; '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; Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, in-person.; Other Names: CPT-NP
Experimental: Experimental CPT via VTC; '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; Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, through videoteleconference.; Other Names: CPT-VTC

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: VA Pacific Islands Health Care System
• Investigators: Principal Investigator: Leslie A. Morland, Psy.D., VA Pacific Islands Healthcare System

Publications and helpful links

General Publications

• Glassman LH, Mackintosh MA, Wells SY, Wickramasinghe I, Walter KH, Morland LA. Predictors of Quality of Life Following Cognitive Processing Therapy Among Women and Men With Post-Traumatic Stress Disorder. Mil Med. 2020 Jun 8;185(5-6):e579-e585. doi: 10.1093/milmed/usz474.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 4, 2015
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimate): February 13, 2015

Study Record Updates

• Last Update Posted (Estimate): February 13, 2015
• Last Update Submitted That Met QC Criteria: February 9, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: W81XWH-10-1-1037; PT090552 (Other Grant/Funding Number: Department of Defense)