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

NCT ID: NCT00941629

Last Updated: 2015-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-11-30

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.

Conditions

Post-Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Processing Therapy FTF

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

Group Type: ACTIVE_COMPARATOR

Cognitive Processing Therapy (CPT)

Intervention Type: BEHAVIORAL

Patients with PTSD receive a trauma-focused, cognitive-behavioral intervention in Face-to -Face treatment.

Cognitive Processing Therapy TMH

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

Group Type: EXPERIMENTAL

Cognitive Processing Therapy (CPT)

Intervention Type: BEHAVIORAL

Provision of Cognitive Processing Therapy over teleconference network (telemental health; telehealth)

Interventions

Cognitive Processing Therapy (CPT)

Patients with PTSD receive a trauma-focused, cognitive-behavioral intervention in Face-to -Face treatment.

Intervention Type: BEHAVIORAL

Cognitive Processing Therapy (CPT)

Provision of Cognitive Processing Therapy over teleconference network (telemental health; telehealth)

Intervention Type: BEHAVIORAL

Other Intervention Names

CPT; CPT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tracey L Smith, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Wm.S. Middleton Memorial Veterans Hospital FWA 00005784

Locations

Edward J. Hines Jr. Veterans Hospital, Cares Research Foundation FWA00001322

Hines, Illinois, United States

Wm. S.Middleton Memorial Veterans Hospital

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26397721 (View on PubMed)

Other Identifiers

PT075415

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HSLC-IRB #H2013-0037

Identifier Type: -

Identifier Source: org_study_id