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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Withdrawn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
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 12, 2012
    Last Updated
    August 18, 2015
    Sponsor
    Emory University
    Collaborators
    Centers for Disease Control and Prevention
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    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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