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Clinical Trials/NCT01623219
NCT01623219WithdrawnNot Applicable

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

Emory University0 sitesStarted: March 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Primary Endpoint
CAPS-Clinician Administered PTSD Scale

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

TeleMedicine Prolonged Exposure

Experimental

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.

Intervention: Prolonged Exposure Therapy (Behavioral)

Outcomes

Primary Outcomes

CAPS-Clinician Administered PTSD Scale

Time Frame: Post-Treatment (10 weeks)

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Barbara O. Rothbaum, PhD

Professor in Psychiatry and Associate Vice Chair of Clinical Research

Emory University

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