Community-Based Telemedicine to Reduce Risk to Georgia Veterans With Post Traumatic Stress Disorder

August 18, 2015 updated by: Barbara O. Rothbaum, PhD, Emory University

Community-Based Telemedicine to Reduce Risk to Georgia Veterans With PTSD

The investigator proposes to examine treatment for Posttraumatic Stress Disorder for Veterans who served in Iraq and Afghanistan provided through telemedicine which connects patients to doctors in different locations using the internet. In this study, Veterans will receive prolonged exposure therapy (PE). This treatment has been shown to be effective in reducing PTSD symptoms. For this study 9 weekly 90 minute sessions will be given over a period of up to 3 months. The first 2 sessions of each treatment will involve education, rational and treatment preparation. Sessions 3-9 will consist of recounting the traumatic event out loud and repeatedly. The purpose of this study is to determine if this treatment is effective when given through telehealth. To this end, the investigators propose to enroll up to 20 individuals who will access the investigators services through the GA telehealth network who has hundreds of telehealth sites across the state of Georgia. Patients will go to these sites to access the investigators therapists using GA telehealth equipment. The investigators hypothesize that PE delivered remotely through telemedicine will work to reduce the symptoms of PTSD.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must meet DSM-IV criteria for PTSD due to exposure to a trauma while serving in Operation Iraqi Freedom, Operation Enduring Freedom-Afghanistan, and/or Operation New Dawn.
  • Patients must be literate in English.
  • Patients must be medically healthy or medically stable such that the stress of the therapy is not contraindicated.
  • Participants must comprehend his or her role in treatment and the risks involved in order to be entered.

Exclusion Criteria:

  • Patients with a history of mania, schizophrenia, or other psychoses
  • Patients with prominent suicidal ideation
  • Patients with current alcohol or drug dependence
  • Patients with special medical conditions such as pregnancy, renal insufficiency, those with various chronic diseases or a history of significant head injury

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TeleMedicine Prolonged Exposure
Veterans will receive prolonged exposure therapy (PE)delivered via telemedicine instead of in person. For this study 9 weekly 90 minute sessions will be given over a period of up to 3 months. The first 2 sessions of each treatment will involve education, rational and treatment preparation. Sessions 3-9 will consist of recounting the traumatic event out loud and repeatedly. The purpose of this study is to determine if this treatment is effective when given through telehealth.
Behavioral: Prolonged Exposure Therapy
Exposure therapy refers to several cognitive behavioral treatment programs that involve confronting feared but safe thoughts, images, objects, situations, or activities in order to reduce unrealistic fear and anxiety. Exposure therapy for PTSD involves prolonged, imaginal exposure to the patient's traumatic memory and in vivo (in real life) exposure to trauma reminders. Prolonged exposure (PE) is a specific exposure therapy program that consists of five components: (1) psychoeducation (2) training in controlled breathing, (3) prolonged imaginal exposure to the trauma memory conducted in therapy sessions and repeated as homework, (4) prolonged in vivo exposure implemented as homework, and (5) processing of the traumatic material to correct maladaptive cognitions.
Other Names:
  • Exposure Therapy
  • PE
  • Imaginal Exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CAPS-Clinician Administered PTSD Scale
Time Frame: Post-Treatment (10 weeks)
Post-Treatment (10 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
BDI-II-Beck Depression Inventory-II
Time Frame: Post-Treatment (10 weeks)
Post-Treatment (10 weeks)
Credibility/Expectancy Questionnaire-CEQ
Time Frame: post treatment (10 weeks)
post treatment (10 weeks)
Client Satisfaction Questionnaire-CSQ
Time Frame: post treatment (10 weeks)
post treatment (10 weeks)
PTSD Symptom Scale Self Report-PSS-SR
Time Frame: Post-Treatment (10 weeks)
Post-Treatment (10 weeks)

Collaborators and Investigators

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

Sponsor

Emory University

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Barbara O Rothbaum, PhD, ABPP, Emory University, School of Medicine, Dept. of Psychiatry

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

March 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

June 15, 2012

First Posted (Estimate)

June 19, 2012

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00055554
  • Telemedicine_ECIC_2012 (Other Identifier: Other)

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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