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Completed

NCT Number: NCT00941629

Comparison of Videoconference and Face-to-Face Delivery of Cognitive Processing Therapy for Posttraumatic Stress Disorder

The purpose of this study is to evaluate the equivalence of CPT treatment delivered remotely via telemental health (TMH) over videoconferencing or via traditional face-to face (FTF) treatment to veterans who have Post-traumatic Stress Disorder (PTSD) from a military-related stressor (i.e., combat, sexual assault, non-combat physical assault). The secondary objective is to determine if patients' ratings of PTSD symptoms, affect, social adjustment, therapy alliance, treatment satisfaction and therapist satisfaction, are equivalent between service-delivery conditions (TMH vs. FTF). A final objective is to develop web-based practice assignments to assist participants in the TMH condition with treatment adherence (completion of the between- session practice assignments).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Edward J. Hines Jr. Veterans Hospital, Cares Research Foundation FWA00001322, Hines, Illinois, United States

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About this study

PTSD is the most common mental health diagnosis affecting service men and women who have served in Iraq and Afghanistan (OEF/OIF). Despite unprecedented efforts by the Dept. of Defense (DoD) and Dept. of Veterans Affairs (VA) to treat these service personnel with mental disorders, significant gaps in the continuum of care for psychological health remain, specifically related to which services are offered, where services are offered, and who receives services. The DoD and VA have also attempted to address problems with accessibility through the development of a video teleconference (VTC) network to ensure that service members have access to top-quality specialized medical care regardless of their geographical location. Provision of medical treatment over VTC is often referred to as telemedicine; telemental health (TMH) refers to the provision of mental health treatment over the same system. A handful of studies have shown that psychiatry (primarily medication management) delivered over TMH systems can be as effective as face-to-face (FTF) treatment as long as the equipment and band-width are capable of delivering the communication in near real time.TMH is an increasingly common method of providing psychological treatment to service members with PTSD and other mental health problems, and yet there are no randomized trials of TMH provision of an empirically validated treatment for PTSD compared with FTF treatment. Therefore, this study aims to evaluate the treatment outcomes of patients with PTSD treated with CPT either remotely via TMH or traditionally in FTF treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or older
  • Literate in written English
  • Fluent in spoken English
  • Verified status as an OEF/OIF veteran
  • Current PTSD diagnosis
  • Index traumatic event related to military services
  • If taking psychotropic medication, remains stable

Exclusion criteria

  • Under 18 years of age
  • Not literate in written English
  • Not fluent in spoke English
  • Current uncontrolled psychotic or bipolar disorder
  • Substance dependence
  • Current uncontrolled suicidal or homicidal ideation
  • Significant cognitive impairment that would interfere with completion of therapy tasks

Treatment and study plan

Cognitive Processing Therapy (CPT)

Behavioral

Patients with PTSD receive a trauma-focused, cognitive-behavioral intervention in Face-to -Face treatment.

Other names: CPT

Primary outcomes

  1. The Clinician Administered PTSD Scale(CAPS) score.

    Time frame: At baseline, post-treatment( after 6 weeks) and the 3-month follow-up period

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study title

Randomized Controlled Equivalence Trial Comparing Videoconference and Face-to-Face Delivery of Cognitive Processing Therapy for PTSD

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jul 17, 2009
Registry last updated
Oct 2, 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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