Comparison of Videoconference and Face-to-Face Delivery of Cognitive Processing Therapy for PTSD
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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 |
- 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 ]
| Estimated Enrollment: | 106 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 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 |
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| United States, Illinois | |
| Edward J. Hines Jr. Veterans Hospital, Cares Research Foundation FWA00001322 | Recruiting |
| Hines, Illinois, United States, 60141 | |
| Contact: Kristen Lamp, MA, LPC 708-202-8387 ext 24761 kristen.lamp@va.gov | |
| Sub-Investigator: Kelly P Maieritsch, Ph.D. | |
| United States, Wisconsin | |
| Wm. S.Middleton Memorial Veterans Hospital | Recruiting |
| Madison, Wisconsin, United States, 53705 | |
| Contact: Yanmin A Li, MBBS 608-263-4290 ali@clinicaltrials.wisc.edu | |
| Contact: Lori Wollet, R.N 608-262-6855 lw3@clinicaltrials.wisc.edu | |
| Principal Investigator: Tracey L Smith, Ph.D. | |
| 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 #2008-0160, PT075415 |
| Study First Received: | July 15, 2009 |
| Last Updated: | March 26, 2012 |
| 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 May 19, 2013