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

NCT01623219 | Withdrawn

• 2 other identifiers: IRB00055554Telemedicine_ECIC_2012
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

PTSD; trauma; combat trauma; veterans; telemedicine; prolonged exposure

Outcome Measures

Primary Outcomes (1)

• CAPS-Clinician Administered PTSD Scale

  Post-Treatment (10 weeks)

Secondary Outcomes (4)

• BDI-II-Beck Depression Inventory-II

  Post-Treatment (10 weeks)

• Credibility/Expectancy Questionnaire-CEQ

  post treatment (10 weeks)

• Client Satisfaction Questionnaire-CSQ

  post treatment (10 weeks)

• PTSD Symptom Scale Self Report-PSS-SR

  Post-Treatment (10 weeks)

Study Arms (1)

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.

Behavioral: Prolonged Exposure Therapy

Interventions

Prolonged Exposure Therapy 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.

Also known as: PE, Exposure Therapy, Imaginal Exposure

TeleMedicine Prolonged Exposure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Centers for Disease Control and Prevention: collaborator

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic; Wounds and Injuries

Interventions

Implosive Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Barbara O Rothbaum, PhD, ABPP

  Emory University, School of Medicine, Dept. of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Psychiatry and Associate Vice Chair of Clinical Research

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 19, 2012
• Study Start: March 1, 2012
• Primary Completion: January 1, 2013
• Last Updated: August 19, 2015

Record last verified: 2015-08