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

NCT01102764 | Completed Results

• 2 other identifiers: IAC 09-04019695
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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). ).

Conditions

PTSD

Keywords

Anxiety Disorders: PTSD; Prolong Exposure (PE); Telemedicine; cost effectiveness; deployment related problems; mental health care delivery

Outcome Measures

Primary Outcomes (3)

• Treatment Completion

  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. Per protocol, participants could have as many as 12 treatment sessions. 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.

  13 weeks

• PTSD Checklist-Military (PCL-M)

  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. 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). Total scores on the PCL range from 17 to 85, with lower scores indicating less symptom severity.

  26 weeks

• Beck Depression Inventory-II (BDI-II)

  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.

  26 weeks

Secondary Outcomes (8)

• Clinician Administered PTSD Scale for DSM-IV (CAPS IV)

  26 weeks

• Deployment Risk and Resiliency Inventory (DRRI)

  Week 0

• Health Related Functioning: Medical Outcome Study (MOS) Short Study Forms-36 Health Survey (SF 36)

  26 weeks

• Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA)

  14 weeks

• Treatment Credibility

  4 weeks

Study Arms (2)

Arm 1: PE via telemedicine

EXPERIMENTAL

PE via telemedicine

Behavioral: Telemedicine

Arm 2: PE in person

ACTIVE COMPARATOR

PE in person

Behavioral: In Person

Interventions

Telemedicine BEHAVIORAL

Prolonged Exposure (PE) therapy provided at patients house via telemedicine

Arm 1: PE via telemedicine

In Person BEHAVIORAL

PE therapy delivered in person at the VAMC

Arm 2: PE in person

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Pennsylvania: collaborator
• University of Hawaii: collaborator

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Related Publications (20)

• 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.

  PMID: 22101225 BACKGROUND

• 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.

  PMID: 22679240 BACKGROUND

• 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.

  PMID: 23148769 BACKGROUND

• 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.

  PMID: 23869250 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24151141 BACKGROUND

• 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.

  PMID: 25040378 BACKGROUND

• 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.

  PMID: 25505798 BACKGROUND

• 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.

  PMID: 25354925 BACKGROUND

• 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.

  PMID: 25809565 BACKGROUND

• 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.

  PMID: 25596624 BACKGROUND

• 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.

  PMID: 25445080 BACKGROUND

• 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.

  PMID: 25764266 BACKGROUND

• 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.

  PMID: 25272341 BACKGROUND

• 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.

  PMID: 24621452 RESULT

• 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.

  PMID: 26375277 RESULT

• 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.

  PMID: 26864655 RESULT

• 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.

  PMID: 26874291 RESULT

• 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.

  RESULT

Related Links

• Click here for more information about this study: Prolonged Exposure (PE) for PTSD: Telemedicine vs. In Person

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Limitations and Caveats

1. The study lacked a third group of participants receiving an alternative intervention to compare PE-HBT with a standard control-group. 2. The achieved effect sizes were less than those typically evident in PE treatment outcome studies

Results Point of Contact

• Title: Ron Acierno, PhD
• Organization: Medical University of South Carolina

acierno@musc.edu

843-792-2949

Study Officials

• Ron E. Acierno, PhD MS BA

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: April 13, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 4, 2019
• Results First Posted: September 1, 2016

Record last verified: 2018-11

Locations

US (1)