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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Tracey Smith, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00941629
First received: July 15, 2009
Last updated: December 31, 2013
Last verified: December 2013

July 15, 2009
December 31, 2013
December 2009
November 2013   (final data collection date for primary outcome measure)
The Clinician Administered PTSD Scale(CAPS) score. [ Time Frame: At baseline, post-treatment( after 6 weeks) and the 3-month follow-up period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00941629 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Videoconference and Face-to-Face Delivery of Cognitive Processing Therapy for Posttraumatic Stress Disorder
Randomized Controlled Equivalence Trial Comparing Videoconference and Face-to-Face Delivery of Cognitive Processing Therapy for PTSD

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Post-Traumatic Stress Disorder
  • Behavioral: Cognitive Processing Therapy (CPT)
    Patients with PTSD receive a trauma-focused, cognitive-behavioral intervention in Face-to -Face treatment.
    Other Name: CPT
  • Behavioral: Cognitive Processing Therapy (CPT)
    Provision of Cognitive Processing Therapy over teleconference network (telemental health; telehealth)
    Other Name: CPT
  • Active Comparator: Cognitive Processing Therapy FTF
    Cognitive Processing Therapy delivered in traditional face-to-face sessions (FTF)
    Intervention: Behavioral: Cognitive Processing Therapy (CPT)
  • Experimental: Cognitive Processing Therapy TMH
    Cognitive Processing Therapy delivered over videoconferencing equipment to a distant location (or telemental health; TMH)
    Intervention: Behavioral: Cognitive Processing Therapy (CPT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00941629
HSLC-IRB #H2013-0037, PT075415
No
Tracey Smith, University of Wisconsin, Madison
University of Wisconsin, Madison
Department of Veterans Affairs
Principal Investigator: Tracey L Smith, Ph.D. Wm.S. Middleton Memorial Veterans Hospital FWA 00005784
University of Wisconsin, Madison
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP