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Completed

NCT Number: NCT02362477

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

VA Pacific Islands Healthcare System

Honolulu, Hawaii, 96819, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Processing Therapy in-person

Behavioral

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

Other names: CPT-NP

Cognitive Processing Therapy through videoteleconference

Behavioral

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

Other names: CPT-VTC

Primary outcomes

  1. Clinician Administered PTSD Scale (CAPS-IV)

    Time frame: 6 months post-treatment

Sponsors and collaborators

Lead sponsor

VA Pacific Islands Health Care System

Fed

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 13, 2015
Registry last updated
Feb 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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