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

This study is currently recruiting participants.
Verified April 2013 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: April 17, 2013
Last verified: April 2013

March 17, 2010
April 17, 2013
October 2010
September 2014   (final data collection date for primary outcome measure)
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 ]
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: pre, post treatment and at 3 and 6 month follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01102764 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: pre, post treatment and at 3 and 6 month follow-up ] [ Designated as safety issue: No ]
  • PTSD Checklist-Military (PCL-M) [ Time Frame: pre, post treatment and at 3 and 6 month follow-up ] [ Designated as safety issue: No ]
  • Deployment Risk and Resiliency Inventory (DRRI) [ Time Frame: pre, post treatment and at 3 and 6 month follow-up ] [ Designated as safety issue: No ]
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: pre, post treatment and at 3 and 6 month follow-up ] [ Designated as safety issue: No ]
  • Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36) [ Time Frame: pre, post treatment and at 3 and 6 month follow-up ] [ Designated as safety issue: No ]
  • Charleston Pscyhiatric Outpatient Satisfaction Scale (CPOSS-VA) [ Time Frame: post treatment and at 3 and 6 month follow-up ] [ Designated as safety issue: No ]
  • Treatment Credibility [ Time Frame: post treatment and at 3 and 6 month follow-up ] [ Designated as safety issue: No ]
  • Service Delievery Perceptions Questionnaire [ Time Frame: post treatment and at 3 and 6 month follow-up ] [ Designated as safety issue: No ]
  • Treatment Adherence [ Time Frame: post treatment and at 3 and 6 month follow-up ] [ Designated as safety issue: No ]
  • Prior Experiecne with Computer and Audiovisual Technology [ Time Frame: post treatment and at 3 and 6 month follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Prolonged Exposure (PE) for Post Traumatic Stress Disorder (PTSD): Telemedicine Versus In Person
Prolonged Exposure (PE) for PTSD: Telemedicine vs. In Person

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). ).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
PTSD
  • Behavioral: Telemedicine
    Prolonged Exposure (PE) therapy provided at patients house via telemedicine
  • Behavioral: In Person
    PE therapy delivered in person at the VAMC
  • Experimental: Arm 1
    PE via telemedicine
    Intervention: Behavioral: Telemedicine
  • Active Comparator: Arm 2
    PE in person
    Intervention: Behavioral: In Person

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
226
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact: Martha K Strachan, PhD (843) 860-7037 martha.strachan@va.gov
United States
 
NCT01102764
IAC 09-040, 19695
No
Department of Veterans Affairs
Department of Veterans Affairs
  • University of Pennsylvania
  • University of Hawaii
Principal Investigator: Ron Acierno, PhD MS BA Ralph H Johnson VA Medical Center, Charleston
Department of Veterans Affairs
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP