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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01102764
Recruitment Status : Completed
First Posted : April 13, 2010
Results First Posted : September 1, 2016
Last Update Posted : September 1, 2016
University of Pennsylvania
University of Hawaii
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
PTSD Behavioral: Telemedicine Behavioral: In Person Not Applicable

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: The investigators 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. The investigators 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Prolonged Exposure (PE) for PTSD: Telemedicine vs. In Person
Study Start Date : October 2010
Actual Primary Completion Date : June 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1: PE via telemedicine
PE via telemedicine
Behavioral: Telemedicine
Prolonged Exposure (PE) therapy provided at patients house via telemedicine
Active Comparator: Arm 2: PE in person
PE in person
Behavioral: In Person
PE therapy delivered in person at the VAMC

Primary Outcome Measures :
  1. 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: 6 months ]
    Per protocol treatment completers completed at least 6 90-minute sessions of Prolonged Exposure either In Person or via Telemedicine. Treatment dropout is defined as initiating treatment but completing fewer than 6 sessions. Per protocol, participants could have as many as 12 treatment sessions.

  2. PCL Scores at Pre and Post Treatment [ Time Frame: 6 months ]
    PTSD Checklist-Military (PCL-M): The PCL is a 17 Item Self Report Measure of PTSD Symptoms Based on the DSM-IV Criteria. The PCL uses a 5-point Likert scale response format ranging from not at all to frequently. Total scores on the PCL range from 17 to 85 (lower scores indicate less symptom severity). The instrument is highly correlated with the Clinician Administered PTSD Scale (r = .93), has good diagnostic efficiency (> .70), and robust psychometrics with a variety of trauma populations (Blanchard, 1996), including combat veterans (Magruder, Frueh, et al, 2005). The minimum score possible on this measure is 17, and the highest possible score is 85.

  3. BDI Scores at Pre and Post Treatment [ Time Frame: 6 months ]
    Beck Depression Inventory-II (BDI-II): (BDI; Beck et al., 1961): The BDI-II is a 21-item self-report scale, is among the most widely used instruments to measure depression. Beck and Steer (1984) demonstrated that the BDI-I has high internal consistency (α = .86 - .91). Lower scores indicate less symptom severity, and higher scores indicate more severe depressive symptoms. Raw scores of 0-13 indicates minimal depression; 14-19 indicates mild depression; 20-28 indicates moderate depression; 29-63 indicates severe depression. The lowest possible score on this measure is 0, and the highest possible score is 63.

Secondary Outcome Measures :
  1. Clinician Administered PTSD Scale (CAPS): PTSD Diagnosis [ Time Frame: 1 year ]
  2. 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 ]
  3. 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 ]
  4. Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA): 16 Item Self Report Scale, General Measure of Patient Satisfaction of Treatment [ Time Frame: 1 year ]
  5. Treatment Credibility: to Assess for Differences in Outcome Expectancy, Treatment Credibility Scales [ Time Frame: 1 year ]
  6. 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 ]
  7. Structured Clinical Interview for DSM-IV: Interview to Diagnosis Depression, Panic Disorder, and Substance Abuse [ Time Frame: 1 year ]
  8. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01102764

United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5799
Sponsors and Collaborators
VA Office of Research and Development
University of Pennsylvania
University of Hawaii
Principal Investigator: Ron E. Acierno, PhD MS BA Ralph H. Johnson VA Medical Center, Charleston, SC

Additional Information:
Publications of Results:
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(4):522-30.
Acierno R, Gros DF, Morland L, Greene C, Strachan MK, Egede LE, Tuerk PW, Frueh BC, Myrick H. Delivery of evidence-based psychotherapy via video telehealth. Journal of psychopathology and behavioral assessment. 2013 Dec 1; 35(4):506-521.

Responsible Party: VA Office of Research and Development Identifier: NCT01102764     History of Changes
Other Study ID Numbers: IAC 09-040
19695 ( Other Identifier: Medical University of South Carolina IRB )
First Posted: April 13, 2010    Key Record Dates
Results First Posted: September 1, 2016
Last Update Posted: September 1, 2016
Last Verified: July 2016

Keywords provided by VA Office of Research and Development:
Anxiety Disorders: PTSD
Prolong Exposure (PE)
cost effectiveness
deployment related problems
mental health care delivery

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders