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

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cognitive Processing Therapy (CPT)
Cognitive Processing Therapy (CPT)
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring PTSD, Telemedicine, Clinical Trial, Psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Edward J. Hines Jr. Veterans Hospital, Cares Research Foundation FWA00001322
  • Wm. S.Middleton Memorial Veterans Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cognitive Processing Therapy FTF

Cognitive Processing Therapy TMH

Arm Description

Cognitive Processing Therapy delivered in traditional face-to-face sessions (FTF)

Cognitive Processing Therapy delivered over videoconferencing equipment to a distant location (or telemental health; TMH)

Outcomes

Primary Outcome Measures

The Clinician Administered PTSD Scale(CAPS) score.

Secondary Outcome Measures

Full Information

First Posted
July 15, 2009
Last Updated
September 30, 2015
Sponsor
University of Wisconsin, Madison
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00941629
Brief Title
Comparison of Videoconference and Face-to-Face Delivery of Cognitive Processing Therapy for Posttraumatic Stress Disorder
Official Title
Randomized Controlled Equivalence Trial Comparing Videoconference and Face-to-Face Delivery of Cognitive Processing Therapy for PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
PTSD, Telemedicine, Clinical Trial, Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Processing Therapy FTF
Arm Type
Active Comparator
Arm Description
Cognitive Processing Therapy delivered in traditional face-to-face sessions (FTF)
Arm Title
Cognitive Processing Therapy TMH
Arm Type
Experimental
Arm Description
Cognitive Processing Therapy delivered over videoconferencing equipment to a distant location (or telemental health; TMH)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy (CPT)
Other Intervention Name(s)
CPT
Intervention Description
Patients with PTSD receive a trauma-focused, cognitive-behavioral intervention in Face-to -Face treatment.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy (CPT)
Other Intervention Name(s)
CPT
Intervention Description
Provision of Cognitive Processing Therapy over teleconference network (telemental health; telehealth)
Primary Outcome Measure Information:
Title
The Clinician Administered PTSD Scale(CAPS) score.
Time Frame
At baseline, post-treatment( after 6 weeks) and the 3-month follow-up period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracey L Smith, Ph.D.
Organizational Affiliation
Wm.S. Middleton Memorial Veterans Hospital FWA 00005784
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edward J. Hines Jr. Veterans Hospital, Cares Research Foundation FWA00001322
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Wm. S.Middleton Memorial Veterans Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26397721
Citation
Miles SR, Smith TL, Maieritsch KP, Ahearn EP. Fear of Losing Emotional Control Is Associated With Cognitive Processing Therapy Outcomes in U.S. Veterans of Afghanistan and Iraq. J Trauma Stress. 2015 Oct;28(5):475-9. doi: 10.1002/jts.22036. Epub 2015 Sep 23.
Results Reference
derived

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

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