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Telemedicine for Improved Delivery of Psychosocial Treatments for Post Traumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT01158001
Recruitment Status : Completed
First Posted : July 8, 2010
Last Update Posted : June 24, 2015
Sponsor:
Collaborators:
United States Department of Defense
University of Pennsylvania
Information provided by (Responsible Party):
Veterans Medical Research Foundation

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The objective of the proposed study is to conduct a systematic comparison of post traumatic stress disorder (PTSD) outcomes for veterans receiving exposure therapy via telemedicine versus in-person care. The primary aim is to determine feasibility: whether telemedicine can be used as a tool to extend effective, specialized mental health services, such as Prolonged Exposure therapy (PE; a therapy designed to help clients face fears related to a traumatic event), to veterans with limited access to care. A secondary aim is to determine if therapy delivered by telemedicine affects the quality of care in terms of clinical outcomes and the quality of patient-therapist interaction. A tertiary aim is to examine whether results from neuropsychological testing predict treatment outcomes.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorders Depression Anxiety Behavioral: Prolonged exposure therapy Not Applicable

Detailed Description:

The objective of the proposed study is to conduct a systematic comparison of post traumatic stress disorder (PTSD) outcomes for veterans receiving exposure therapy via telemedicine versus in-person care. Specifically, prolonged exposure therapy (PE) was conducted with veterans individually, either in person or via videoconferencing technology. PE is designed to help clients face fears related to a traumatic experience by guiding individuals through exposures to the memory of the event (called "imaginal exposure") and exposures to feared situations (called "in vivo" exposures).

The primary aim is to determine the feasibility of whether telemedicine can be used as a tool to extend effective, specialized mental health services, such as PE to veterans with limited access to care. This is measured in part through patient and therapist satisfaction ratings in each condition.

A secondary aim is to determine if therapy delivered by telemedicine affects the quality of care in terms of clinical outcomes and the quality of patient-therapist interaction. This is measured by relative changes in symptoms, primarily in PTSD, depressive symptoms, and anxiety symptoms.

A tertiary aim is to examine whether results from neuropsychological testing predict treatment outcomes across conditions. This includes seven measures of executive functioning. The hypothesis is that poorer performance on these measures may be associated with less improvement on measures of symptom severity.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telemedicine for Improved Delivery of Psychosocial Treatments for Post Traumatic Stress Disorder
Study Start Date : May 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : September 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Psychotherapy via telemedicine
In this arm, veterans received standard psychotherapy (prolonged exposure therapy) in a novel format - interacting with a therapist via videoconferencing.
 Behavioral: Prolonged exposure therapy
Twelve sessions (90 minutes each) of prolonged exposure therapy
Active Comparator: Face-to-face (in person) psychotherapy
In this arm, veterans received standard psychotherapy (prolonged exposure therapy) in the traditional format - in person with a therapist.
 Behavioral: Prolonged exposure therapy
Twelve sessions (90 minutes each) of prolonged exposure therapy


Outcome Measures
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Primary Outcome Measures :
  1. Clinician-administered PTSD Scale (CAPS) diagnostic interview [ Time Frame: Pre-treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessment ]
    Measure of PTSD diagnosis and severity


Secondary Outcome Measures :
  1. PHQ-9 (self-reported depression) [ Time Frame: Pre-treatment, weekly during 12 weeks of treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessment ]
    Measure of depressive symptoms

  2. PTSD Checklist (PCL; self-reported PTSD symptoms) [ Time Frame: Pre-treatment, weekly during 12 weeks of treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessment ]
    Measure of 17 posttraumatic stress disorder (PTSD) symptoms from specific event (PCL-S)

  3. Neuropsychological testing battery to assess cognitive functioning [ Time Frame: Pre-treatment and post-treatment (14 weeks after pre-treatment assessment) ]
    1. Wechsler Test of Adult Reading
    2. Rey Complex Figure task
    3. California Verbal Learning Test
    4. Wisconsin Card Sort Test
    5. Wechsler Adult Intelligence Scale Digit Span
    6. Delis-Kaplan Executive Functioning System (D-KEFS) Verbal Fluency
    7. Delis-Kaplan Executive Functioning System (D-KEFS) Color-Word Interference
    8. Delis-Kaplan Executive Functioning System (D-KEFS) Trails


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary diagnosis of chronic PTSD due to combat; comorbid mood and anxiety disorders are expected, and will be permitted (to maximize generalizability) if PTSD symptoms are judged to be predominant based on primacy and severity of symptoms
  • Age 18 or older
  • English literacy

Exclusion Criteria:

  • Unmanaged psychosis or manic episodes in past year
  • Concurrent psychotherapies targeting PTSD or depression or that entail exposure therapy [veterans who are engaged in treatment for non-PTSD symptoms (e.g., 12-step programs for substance problems) will be eligible]
  • Severe cardiovascular or respiratory disease that would make it difficult to ensure regular attendance at psychotherapy sessions
  • Probable dementia; OR
  • Head trauma resulting in loss of consciousness longer than 20 minutes. Potential participants who have had changes in the type and dosage of psychotropic medications in the preceding two months will be asked to wait until their medication regimen has stabilized to minimize treatment confounds.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158001


Locations
United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92108
Sponsors and Collaborators
Veterans Medical Research Foundation
United States Department of Defense
University of Pennsylvania
Investigators
Principal Investigator: Steven R. Thorp, PhD Veterans Affairs San Diego Healthcare System
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01158001     History of Changes
Other Study ID Numbers: 080513
PT074431
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Keywords provided by Veterans Medical Research Foundation:
Posttraumatic stress disorders
Telemedicine
Psychotherapy
Neuropsychological test
Depression

Additional relevant MeSH terms:
Disease
Depression
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
 Pathologic Processes
Behavioral Symptoms
Trauma and Stressor Related Disorders
Mental Disorders