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
  Purpose

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).


Condition Intervention Phase
Post-Traumatic Stress Disorder
Behavioral: Cognitive Processing Therapy (CPT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Equivalence Trial Comparing Videoconference and Face-to-Face Delivery of Cognitive Processing Therapy for PTSD

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 ]

Enrollment: 90
Study Start Date: December 2009
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cognitive Processing Therapy FTF
Cognitive Processing Therapy delivered in traditional face-to-face sessions (FTF)
Behavioral: Cognitive Processing Therapy (CPT)
Patients with PTSD receive a trauma-focused, cognitive-behavioral intervention in Face-to -Face treatment.
Other Name: CPT
Experimental: Cognitive Processing Therapy TMH
Cognitive Processing Therapy delivered over videoconferencing equipment to a distant location (or telemental health; TMH)
Behavioral: Cognitive Processing Therapy (CPT)
Provision of Cognitive Processing Therapy over teleconference network (telemental health; telehealth)
Other Name: CPT

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00941629

Locations
United States, Illinois
Edward J. Hines Jr. Veterans Hospital, Cares Research Foundation FWA00001322
Hines, Illinois, United States, 60141
United States, Wisconsin
Wm. S.Middleton Memorial Veterans Hospital
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Tracey L Smith, Ph.D. Wm.S. Middleton Memorial Veterans Hospital FWA 00005784
  More Information

No publications provided

Responsible Party: Tracey Smith, PhD, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00941629     History of Changes
Other Study ID Numbers: HSLC-IRB #H2013-0037, PT075415
Study First Received: July 15, 2009
Last Updated: December 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
PTSD
Telemedicine
Clinical Trial
Psychotherapy

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014