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

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Completed

CT.gov ID

NCT00941629

Collaborator

US Department of Veterans Affairs (U.S. Fed)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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).

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

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 Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized Controlled Equivalence Trial Comparing Videoconference and Face-to-Face Delivery of Cognitive Processing Therapy for PTSD

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: CPT

Arm

Intervention/Treatment

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 Names:

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 Names:

CPT

Outcome Measures

Primary Outcome Measures

The Clinician Administered PTSD Scale(CAPS) score. [At baseline, post-treatment( after 6 weeks) and the 3-month follow-up period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Edward J. Hines Jr. Veterans Hospital, Cares Research Foundation FWA00001322	Hines	Illinois	United States	60141
2	Wm. S.Middleton Memorial Veterans Hospital	Madison	Wisconsin	United States	53705