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

Not Applicable

Withdrawn

• Conditions: Post Traumatic Stress Disorder, PTSD
• Interventions: Behavioral: Prolonged Exposure Therapy

• Registration Number: NCT01623219
• Lead Sponsor: Emory University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-06-15
• Study First Posted: 2012-06-19
• Primary Completion: 2013-01
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TeleMedicine Prolonged Exposure	Prolonged Exposure Therapy	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.

Primary Outcome Measures

Name	Time	Method
CAPS-Clinician Administered PTSD Scale	Post-Treatment (10 weeks)

Secondary Outcome Measures

Name	Time	Method
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)