Prolonged Exposure (PE) for Post Traumatic Stress Disorder (PTSD): Telemedicine Versus In Person

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Department of Veterans Affairs
Sponsor:
Collaborators:
University of Pennsylvania
University of Hawaii
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01102764
First received: March 17, 2010
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

The present proposal is to study whether Prolonged Exposure (PE) delivered via Telemedicine is as effective as PE delivered In Person for Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF) Veterans and Veterans of all theatres, particularly Vietnam era with Post-Traumatic Stress Disorder (PTSD). ).


Condition Intervention
PTSD
Behavioral: Telemedicine
Behavioral: In Person

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Prolonged Exposure (PE) for PTSD: Telemedicine vs. In Person

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The major objective of this study is to determine if PE delivered via Telemedicine is as effective as In Person PE in terms of (1) clinical (PTSD and Depression); (2) process (Treatment Satisfaction and Attrition); and (3) economic (Cost) outcomes. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS): PTSD diagnosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • PTSD Checklist-Military (PCL-M): The PCL is a 17 item self report measure of PTSD symptoms based on the DSM-IV criteria [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Deployment Risk and Resiliency Inventory (DRRI): Self report measure assessing 14 key deployment-related risk and resilience factors with demonstrated implications for Veterans' long term health [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Beck Depression Inventory-II (BDI-II): 21 item self report scales to measure depression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36): self report scale measures health status and functioning over the past four weeks [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA): 16 item self report scale, general measure of patient satisfaction of treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Treatment Credibility: to assess for differences in outcome expectancy, treatment credibility scales [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Service Delivery Perceptions Questionnaire: assess subjects' perceptions about variables specifically related to the mode of service delivery (quality of communication, ease of use, willingness to use treatment) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Structured Clinical Interview for DSM-IV: Interview to diagnosis Depression, Panic Disorder, and Substance Abuse [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Prior Experience with Computer and Audiovisual Technology: short measure to learn more about participants' prior experience and comfort level with computers and audiovisual technology [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 226
Study Start Date: October 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
PE via telemedicine
Behavioral: Telemedicine
Prolonged Exposure (PE) therapy provided at patients house via telemedicine
Active Comparator: Arm 2
PE in person
Behavioral: In Person
PE therapy delivered in person at the VAMC

Detailed Description:

Project Background/Rationale: Approximately 15 to 17% of current Iraq war veterans meet full diagnostic criteria for MH problems such as post-traumatic stress disorder (PTSD) (Hoge et al., 2004). Prolonged Exposure (PE) is an empirically supported treatment for PTSD (Foa 1997; Schnurr et al., 2007), and has been adopted by the Department of Veterans Affairs (DOVA) as one of the treatments of choice for the disorder, as evident by the DOVA-sponsored national training of clinicians to use PE. It is therefore important to employ treatment delivery methods that maximize the likelihood that all veterans in need, including veterans residing in rural settings, and veterans who avoid DOVA settings due to the stigma of receiving mental health treatment, will receive interventions such as PE. The May, 2005 Committee on Veterans Affairs, Subcommittee on Health has identified Telemedicine as a DOVA priority area to address this need. The present proposal is to study whether PE delivered via Telemedicine is as effective as PE delivered In Person. Telemedicine has been chosen for its ability to overcome what appear to be two major barriers to mental health care (Frueh et al., 2000): the difficulty that rural-residing veterans face in reaching VAMC facilities, and the stigma veterans perceive related to receiving mental health treatment. Indeed, if effective, PE delivered via telemedicine may address the problem inherent in the finding that 42% of those screening positive for PTSD indicate that they are interested in receiving help, but only 25% actually receive services (Hoge, et al., 2006).

Project Objectives: Although effective treatments for PTSD exist and have been adopted by the Veterans Affairs Medical Centers (VAMC), barriers to care of a social (e.g., stigma) and geographic (e.g., rural) nature prevent many veterans in need from receiving care. Telemedicine might address this need. The major objective of this study is to determine if PE delivered via Telemedicine is as effective as In Person PE in terms of (1) clinical; (2) process; and (3) economic outcomes.

Project Methods: We propose to use a randomized between groups repeated measures (baseline, post-treatment, 3& 6-month followups) design with 226 OIF-OEF veterans diagnosed with PTSD to assess the relative effectiveness, measured in terms of symptoms, patient satisfaction, and costs, of PE delivered via Telemedicine vs. In Person formats. We hypothesize that no differences (i.e., non-inferiority) between the two formats will be evident in terms treatment gains, patient satisfaction, treatment attrition, patient satisfaction and direct health care costs.

Anticipated Impacts on Veterans Health care: This study will provide important information regarding whether PE delivered via home-based Telemedicine equipment is as effective as traditional In Person delivery of PE for post-traumatic stress disorder. If shown to be as effective as In Person treatment, a new, innovative, and cost effective intervention delivery system for PTSD will have initial empirical support.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants will be 226 male and female:

  • Operation Iraqi Freedom, Operation Enduring Freedom (OIF OEF) Veterans, and Veterans of all theatres, particularly Vietnam era Veterans.
  • age 21 and above, and
  • diagnosed via structured clinical interview with PTSD

Exclusion Criteria:

  • Actively psychotic or demented persons,
  • individuals with both suicidal ideation and clear intent, and
  • individuals meeting full criteria for substance dependence will be excluded from participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102764

Contacts
Contact: Ron Acierno, PhD MS BA (843) 789-7246 ron.acierno@va.gov
Contact: Kenneth J Ruggiero, PhD MA BA (843) 789-7587 Kenneth.Ruggiero@va.gov

Locations
United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC Recruiting
Charleston, South Carolina, United States, 29401-5799
Contact: Ron Acierno, PhD MS BA    (843) 789-7246    ron.acierno@va.gov   
Contact: Kenneth J Ruggiero, PhD MA BA    (843) 789-7587    Kenneth.Ruggiero@va.gov   
Sub-Investigator: Clara E. Dismuke, PhD BS         
Sub-Investigator: Kenneth J Ruggiero, PhD MA BA         
Sub-Investigator: Peter W. Tuerk, BA MA PhD         
Sub-Investigator: Rebecca Grant Knapp, BS MS PhD         
Principal Investigator: Ron Acierno, PhD MS BA         
Sponsors and Collaborators
University of Pennsylvania
University of Hawaii
Investigators
Principal Investigator: Ron Acierno, PhD MS BA Ralph H Johnson VA Medical Center, Charleston
  More Information

Additional Information:
Publications:
Gros DF, Gros K, Acierno R, Frueh BC, Moreland L. Relation between treatment satisfaction and treatment outcome in veterans with posttraumatic stress disorder. Journal of psychopathology and behavioral assessment. 2013 Jun 28; 35(2):10.

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01102764     History of Changes
Other Study ID Numbers: IAC 09-040, 19695
Study First Received: March 17, 2010
Last Updated: July 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Anxiety Disorders: PTSD
Prolong Exposure (PE)
Telemedicine
cost effectiveness
deployment related problems
mental health care delivery

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 01, 2014