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

NCT ID: NCT01623219

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31

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.

Conditions

Post Traumatic Stress Disorder, PTSD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Prolonged Exposure Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

PE; Exposure Therapy; Imaginal 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Barbara O. Rothbaum, PhD

Professor in Psychiatry and Associate Vice Chair of Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara O Rothbaum, PhD, ABPP

Role: PRINCIPAL_INVESTIGATOR

Emory University, School of Medicine, Dept. of Psychiatry

Other Identifiers

Telemedicine_ECIC_2012

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00055554

Identifier Type: -

Identifier Source: org_study_id