Post Traumatic Stress Disorder, PTSD Clinical Trial
Official title:
Community-Based Telemedicine to Reduce Risk to Georgia Veterans With PTSD
| Verified date | August 2015 |
| Source | Emory University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Emory University | Centers for Disease Control and Prevention |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | CAPS-Clinician Administered PTSD Scale | Post-Treatment (10 weeks) | No | |
| Secondary | BDI-II-Beck Depression Inventory-II | Post-Treatment (10 weeks) | No | |
| Secondary | Credibility/Expectancy Questionnaire-CEQ | post treatment (10 weeks) | No | |
| Secondary | Client Satisfaction Questionnaire-CSQ | post treatment (10 weeks) | No | |
| Secondary | PTSD Symptom Scale Self Report-PSS-SR | Post-Treatment (10 weeks) | No |