Comparison of Videoconference and Face-to-Face Delivery of Cognitive Processing Therapy for Posttraumatic Stress Disorder
September 30, 2015 updated by: University of Wisconsin, Madison
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Hines, Illinois, United States, 60141
- Edward J. Hines Jr. Veterans Hospital, Cares Research Foundation FWA00001322
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Wisconsin
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Madison, Wisconsin, United States, 53705
- Wm. S.Middleton Memorial Veterans Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Cognitive Processing Therapy FTF
Cognitive Processing Therapy delivered in traditional face-to-face sessions (FTF)
|
Patients with PTSD receive a trauma-focused, cognitive-behavioral intervention in Face-to -Face treatment.
Other Names:
Provision of Cognitive Processing Therapy over teleconference network (telemental health; telehealth)
Other Names:
|
|
Experimental: Cognitive Processing Therapy TMH
Cognitive Processing Therapy delivered over videoconferencing equipment to a distant location (or telemental health; TMH)
|
Patients with PTSD receive a trauma-focused, cognitive-behavioral intervention in Face-to -Face treatment.
Other Names:
Provision of Cognitive Processing Therapy over teleconference network (telemental health; telehealth)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The Clinician Administered PTSD Scale(CAPS) score.
Time Frame: At baseline, post-treatment( after 6 weeks) and the 3-month follow-up period
|
At baseline, post-treatment( after 6 weeks) and the 3-month follow-up period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tracey L Smith, Ph.D., Wm.S. Middleton Memorial Veterans Hospital FWA 00005784
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
July 15, 2009
First Submitted That Met QC Criteria
July 16, 2009
First Posted (Estimate)
July 17, 2009
Study Record Updates
Last Update Posted (Estimate)
October 2, 2015
Last Update Submitted That Met QC Criteria
September 30, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSLC-IRB #H2013-0037
- PT075415 (Other Grant/Funding Number: DOD PT075415)
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