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

November 1, 2018 updated by: VA Office of Research and Development

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). ).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29401-5799
        • Ralph H. Johnson VA Medical Center, Charleston, SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Completion
Time Frame: 13 weeks
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)
Time Frame: 26 weeks
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)
Time Frame: 26 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician Administered PTSD Scale for DSM-IV (CAPS IV)
Time Frame: 26 weeks
The Clinician Administered PTSD Scale (CAPS) is a structured interview designed to make a categorical PTSD diagnosis, as well as to provide a measure of PTSD symptom severity. The structure corresponds to the DSM-IV criteria for PTSD diagnoses, with B, C, and D symptoms rated for both frequency and intensity; these two scores (frequency + intensity) are summed to provide severity ratings. Additional questions assess Criteria A, E, and F. It is recommended that the "1, 2" rule be used to determine whether a symptom meets criteria; that is, a frequency score of at least 1 (scale 0 = "none of the time" to 4 = "most or all of the time") and an intensity score of at least 2 (scale 0 = "none" to 4 = "extreme") is required for a particular symptom to meet criteria. Total scores from B, C and D range from 0 to 136, with lower scores indicating better outcomes, and higher scores indicating worse outcomes.
26 weeks
Deployment Risk and Resiliency Inventory (DRRI)
Time Frame: Week 0
The DRRI is collection of self-report measures assessing 14 key deployment-related risk and resilience factors with demonstrated implications for veterans' long-term health. With the nature of military deployment changing, with a larger proportion of women, National Guard and Reserves being deployed for more contemporary conflicts, the DRRI was developed to provide a more comprehensive assessment of the current combat-related experiences. The DRRI is made up of multiple scales to represent different constructs. Responses are either dichotomous (0=No, 1=Yes), polytomous (0=No, 1=Not Sure, 2=Yes), or recorded on a 4, 5 or 6 point Likert scales. Scores for each section are summed are contain scoring ranges. Higher scores are indicative of worse outcomes.
Week 0
Health Related Functioning: Medical Outcome Study (MOS) Short Study Forms-36 Health Survey (SF 36)
Time Frame: 26 weeks
The MOS SF-36 is an indicator of overall health status. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each of the eight summed scores is linearly transformed onto a scale from 0 (negative health) to 100 (positive health) to provide a score for each subscale. Therefore, lower scores indicate more disability while higher scores indicate less disability. Each subscale can be used independently. Sections of the SF-36 include: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health.
26 weeks
Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA)
Time Frame: 14 weeks
The CPOSS is a 16-item measure, with a Likert scale response format, based on a general measure of patient satisfaction. Extant data demonstrate that the measure has excellent reliability (alpha = 0.96) and good convergent validity with relevant anchor items ("would you recommend this treatment to a friend or family member?"). Items are scored using a 5 point Likert scale (5=excellent; 4=very good; 3=good; 2=fair; 1=poor). The scale is scored by summing the scores of all individual items. The possible range is 16 to 80, with higher scores indicating higher satisfaction.
14 weeks
Treatment Credibility
Time Frame: 4 weeks
This measures assesses for differences in outcome expectancy. The Treatment Credibility Scale (as used in this study) contains 4 questions. Each question is scored individually via 10-point Likert scales. Questions asses how logical treatment seems, how confident participants are about treatment, and expectations of success and is administered at treatment session 4. Scores on treatment logicality, confidence and predicted success on each question range from 1 (not at all) to 10 (very logical), with mid-range scores indicating moderate logicality, confidence and predicted success.
4 weeks
Service Delivery Perceptions Questionnaire
Time Frame: 26 weeks
This measure is used to assess Veterans' perceptions about variables specifically related to this mode of service delivery (e.g., the quality of communication, ease of use, and willingness to use treatment via videoconferencing in the future). There are 8 questions (1 question was not assessed due to asking about group participation which is irrelevant to the current study). All questions are answered via a 5 point Likert scale, with 1 indicating poor perceptions and 5 indicating excellent perceptions. Scores range from 7-35, with higher scores indicating more positive outcomes.
26 weeks
Structured Clinical Interview for DSM-IV (SCID-I)
Time Frame: 26 weeks
The Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) is a semistructured interview to determine whether an individual meets criteria for any Axis I disorder in the Diagnostic and Statistical Manual of Mental Disorders (version IV). The SCID is broken down into separate modules corresponding to categories of diagnoses, and uses skip logic to allow the interviewer to skip questions or modules if certain diagnostic criteria are indicated. Most sections begin with an entry question that would allow the interviewer to "skip" the associated questions if not met. For all diagnoses symptoms are coded as present, subthreshold, or absent. It assesses for both current and lifetime diagnoses and prompts the interviewer to document age of illness onset and to rate current illness severity (Glasofer et al., 2015).
26 weeks
Prior Experience With Computer and Audiovisual Technology
Time Frame: Week 0
The Prior Experience With Technology questionnaire is an 8-item short measure to learn more about participants' prior experiences and comfort level with computers and audiovisual technology. For 8 different technological devices, the measure asks if the participant has the device in his/her home (i.e. Is there a telephone in your home)? Subsequent questions determine whether the patient is comfortable using that device or, if he/she does not own one, if he/she would be willing to learn to use one. Devices assessed include telephone, television, stereo, video player (e.g. VCR, DVD), computer, internet, e-mail, and audiovisual conferencing technology. These data may help identify whether these variables are associated with clinical outcome.
Week 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

University of Pennsylvania
University of Hawaii

Investigators

  • Principal Investigator: Ron E. Acierno, PhD MS BA, Ralph H. Johnson VA Medical Center, Charleston, SC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

March 17, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 13, 2010

Study Record Updates

Last Update Posted (Actual)

March 4, 2019

Last Update Submitted That Met QC Criteria

November 1, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAC 09-040
  • 19695 (Other Identifier: Medical University of South Carolina IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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