Prolonged Exposure (PE) for Post Traumatic Stress Disorder (PTSD): Telemedicine Versus In Person
NCT ID: NCT01102764
Last Updated: 2019-03-04
Study Results
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View full resultsBasic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2010-10-31
2015-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Arm 1: PE via telemedicine
PE via telemedicine
Telemedicine
Prolonged Exposure (PE) therapy provided at patients house via telemedicine
Arm 2: PE in person
PE in person
In Person
PE therapy delivered in person at the VAMC
Interventions
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Telemedicine
Prolonged Exposure (PE) therapy provided at patients house via telemedicine
In Person
PE therapy delivered in person at the VAMC
Eligibility Criteria
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Inclusion Criteria
* 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
* individuals with both suicidal ideation and clear intent, and
* individuals meeting full criteria for substance dependence will be excluded from participation
21 Years
99 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
University of Hawaii
OTHER
VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Ron E. Acierno, PhD MS BA
Role: PRINCIPAL_INVESTIGATOR
Ralph H. Johnson VA Medical Center, Charleston, SC
Locations
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Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States
Countries
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References
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Strachan M, Gros DF, Yuen E, Ruggiero KJ, Foa EB, Acierno R. Home-based telehealth to deliver evidence-based psychotherapy in veterans with PTSD. Contemp Clin Trials. 2012 Mar;33(2):402-9. doi: 10.1016/j.cct.2011.11.007. Epub 2011 Nov 11.
Gros DF, Price M, Strachan M, Yuen EK, Milanak ME, Acierno R. Behavioral activation and therapeutic exposure: an investigation of relative symptom changes in PTSD and depression during the course of integrated behavioral activation, situational exposure, and imaginal exposure techniques. Behav Modif. 2012 Jul;36(4):580-99. doi: 10.1177/0145445512448097. Epub 2012 Jun 7.
Tuerk PW, Wangelin B, Rauch SA, Dismuke CE, Yoder M, Myrick H, Eftekhari A, Acierno R. Health service utilization before and after evidence-based treatment for PTSD. Psychol Serv. 2013 Nov;10(4):401-9. doi: 10.1037/a0030549. Epub 2012 Nov 12.
Price M, Gros DF, Strachan M, Ruggiero KJ, Acierno R. The Role of Social Support in Exposure Therapy for Operation Iraqi Freedom/Operation Enduring Freedom Veterans: A Preliminary Investigation. Psychol Trauma. 2013 Jan 1;5(1):93-100. doi: 10.1037/a0026244.
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.
Gros DF, Price M, Yuen EK, Acierno R. Predictors of completion of exposure therapy in OEF/OIF veterans with posttraumatic stress disorder. Depress Anxiety. 2013 Nov;30(11):1107-13. doi: 10.1002/da.22207. Epub 2013 Oct 21.
Soltis K, Acierno R, Gros DF, Yoder M, Tuerk PW. Post-traumatic stress disorder: ethical and legal relevance to the criminal justice system. J Law Med Ethics. 2014 Summer;42(2):147-54. doi: 10.1111/jlme.12130.
Paul LA, Gros DF, Strachan M, Worsham G, Foa EB, Acierno R. Prolonged Exposure for Guilt and Shame in a Veteran of Operation Iraqi Freedom. Am J Psychother. 2014 Sep 1;68(3):277-286. doi: 10.1176/appi.psychotherapy.2014.68.3.277.
Hernandez-Tejada MA, Zoller JS, Ruggiero KJ, Kazley AS, Acierno R. Early treatment withdrawal from evidence-based psychotherapy for PTSD: telemedicine and in-person parameters. Int J Psychiatry Med. 2014;48(1):33-55. doi: 10.2190/PM.48.1.d.
Yuen EK, Gros DF, Price M, Zeigler S, Tuerk PW, Foa EB, Acierno R. Randomized Controlled Trial of Home-Based Telehealth Versus In-Person Prolonged Exposure for Combat-Related PTSD in Veterans: Preliminary Results. J Clin Psychol. 2015 Jun;71(6):500-12. doi: 10.1002/jclp.22168. Epub 2015 Mar 25.
Badour CL, Gros DF, Szafranski DD, Acierno R. Problems in sexual functioning among male OEF/OIF veterans seeking treatment for posttraumatic stress. Compr Psychiatry. 2015 Apr;58:74-81. doi: 10.1016/j.comppsych.2014.12.012. Epub 2014 Dec 30.
Zhang J, Sheerin C, Mandel H, Banducci AN, Myrick H, Acierno R, Amstadter AB, Wang Z. Variation in SLC1A1 is related to combat-related posttraumatic stress disorder. J Anxiety Disord. 2014 Dec;28(8):902-7. doi: 10.1016/j.janxdis.2014.09.013. Epub 2014 Oct 5.
Pelton D, Wangelin B, Tuerk P. Utilizing Telehealth to Support Treatment of Acute Stress Disorder in a Theater of War: Prolonged Exposure via Clinical Videoconferencing. Telemed J E Health. 2015 May;21(5):382-7. doi: 10.1089/tmj.2014.0111. Epub 2015 Mar 12.
Tuerk PW. Starting from something: augmenting exposure therapy and methods of inquiry. Am J Psychiatry. 2014 Oct;171(10):1034-7. doi: 10.1176/appi.ajp.2014.14070880. No abstract available.
Hershenberg R, Paulson D, Gros DF, Acierno R. Does Amount and Type of Activity Matter in Behavioral Activation? A Preliminary Investigation of the Relationship between Pleasant, Functional, and Social Activities and Outcome. Behav Cogn Psychother. 2015 Jul;43(4):396-411. doi: 10.1017/S1352465813001185. Epub 2014 Mar 13.
Price M, Kuhn E, Hoffman JE, Ruzek J, Acierno R. Comparison of the PTSD Checklist (PCL) Administered via a Mobile Device Relative to a Paper Form. J Trauma Stress. 2015 Oct;28(5):480-3. doi: 10.1002/jts.22037. Epub 2015 Sep 16.
Acierno R, Gros DF, Ruggiero KJ, Hernandez-Tejada BM, Knapp RG, Lejuez CW, Muzzy W, Frueh CB, Egede LE, Tuerk PW. BEHAVIORAL ACTIVATION AND THERAPEUTIC EXPOSURE FOR POSTTRAUMATIC STRESS DISORDER: A NONINFERIORITY TRIAL OF TREATMENT DELIVERED IN PERSON VERSUS HOME-BASED TELEHEALTH. Depress Anxiety. 2016 May;33(5):415-23. doi: 10.1002/da.22476. Epub 2016 Feb 10.
Korte KJ, Allan NP, Gros DF, Acierno R. Differential treatment response trajectories in individuals with subclinical and clinical PTSD. J Anxiety Disord. 2016 Mar;38:95-101. doi: 10.1016/j.janxdis.2016.01.006. Epub 2016 Jan 21.
Acierno RE. Symptoms of posttraumatic stress disorder and major depressive disorder in veterans of Operations Enduring/Iraqi Freedom in comparison with those veterans of other conflicts. Military Behavioral Health. 2016 Apr 25; 4(4):383-389.
Related Links
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Click here for more information about this study: Prolonged Exposure (PE) for PTSD: Telemedicine vs. In Person
Other Identifiers
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19695
Identifier Type: OTHER
Identifier Source: secondary_id
IAC 09-040
Identifier Type: -
Identifier Source: org_study_id
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