Community-Based Telemedicine to Reduce Risk to Georgia Veterans With Post Traumatic Stress Disorder
Primary Purpose
Post Traumatic Stress Disorder, PTSD
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prolonged Exposure Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder, PTSD focused on measuring PTSD, trauma, combat trauma, veterans, telemedicine, prolonged exposure
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TeleMedicine Prolonged Exposure
Arm Description
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.
Outcomes
Primary Outcome Measures
CAPS-Clinician Administered PTSD Scale
Secondary Outcome Measures
BDI-II-Beck Depression Inventory-II
Credibility/Expectancy Questionnaire-CEQ
Client Satisfaction Questionnaire-CSQ
PTSD Symptom Scale Self Report-PSS-SR
Full Information
NCT ID
NCT01623219
First Posted
June 12, 2012
Last Updated
August 18, 2015
Sponsor
Emory University
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT01623219
Brief Title
Community-Based Telemedicine to Reduce Risk to Georgia Veterans With Post Traumatic Stress Disorder
Official Title
Community-Based Telemedicine to Reduce Risk to Georgia Veterans With PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Centers for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, PTSD
Keywords
PTSD, trauma, combat trauma, veterans, telemedicine, prolonged exposure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TeleMedicine Prolonged Exposure
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Prolonged Exposure Therapy
Other Intervention Name(s)
PE, Exposure Therapy, Imaginal Exposure
Intervention Description
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.
Primary Outcome Measure Information:
Title
CAPS-Clinician Administered PTSD Scale
Time Frame
Post-Treatment (10 weeks)
Secondary Outcome Measure Information:
Title
BDI-II-Beck Depression Inventory-II
Time Frame
Post-Treatment (10 weeks)
Title
Credibility/Expectancy Questionnaire-CEQ
Time Frame
post treatment (10 weeks)
Title
Client Satisfaction Questionnaire-CSQ
Time Frame
post treatment (10 weeks)
Title
PTSD Symptom Scale Self Report-PSS-SR
Time Frame
Post-Treatment (10 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara O Rothbaum, PhD, ABPP
Organizational Affiliation
Emory University, School of Medicine, Dept. of Psychiatry
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Community-Based Telemedicine to Reduce Risk to Georgia Veterans With Post Traumatic Stress Disorder
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