Prolonged Exposure (PE) for Post Traumatic Stress Disorder (PTSD): Telemedicine Versus In Person
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
|Official Title:||Prolonged Exposure (PE) for PTSD: Telemedicine vs. In Person|
- 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 ] [ Designated as safety issue: No ]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.
- PCL Scores at Pre and Post Treatment [ Time Frame: 6 months ] [ 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. 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.
- BDI Scores at Pre and Post Treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- Clinician Administered PTSD Scale (CAPS): PTSD Diagnosis [ 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 ]
- 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 ]
|Study Start Date:||October 2010|
|Study Completion Date:||September 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm 1: PE via telemedicine
PE via 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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102764
|United States, South Carolina|
|Ralph H. Johnson VA Medical Center, Charleston, SC|
|Charleston, South Carolina, United States, 29401-5799|
|Principal Investigator:||Ron E. Acierno, PhD MS BA||Ralph H. Johnson VA Medical Center, Charleston, SC|