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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Veterans Medical Research Foundation.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Pennsylvania
Information provided by:
Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT01158001
First received: February 20, 2009
Last updated: December 1, 2010
Last verified: December 2010
  Purpose

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 Intervention
Posttraumatic Stress Disorders
Depression
Anxiety
Behavioral: Prolonged exposure therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telemedicine for Improved Delivery of Psychosocial Treatments for Post Traumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by Veterans Medical Research Foundation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Measure of PTSD diagnosis and severity

  • Neuropsychological testing battery to assess cognitive functioning [ Time Frame: Pre-treatment and post-treatment (14 weeks after pre-treatment assessment) ] [ Designated as safety issue: No ]
    1. Wechsler Test of Adult Reading
    2. Rey Complex Figure task
    3. California Verbal Learning Test
    4. Wisconsin Card Sort Test
    5. WAIS Digit Span
    6. D-KEFS Verbal Fluency
    7. D-KEFS Color-Word Interference
    8. D-KEFS Trails


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Measure of depressive symptoms

  • 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 ] [ Designated as safety issue: No ]
    Measure of 17 posttraumatic stress disorder (PTSD) symptoms from specific event (PCL-S)


Estimated Enrollment: 254
Study Start Date: May 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Psychotherapy via telemedicine (video teleconferencing technology).
Behavioral: Prolonged exposure therapy
Twelve sessions (90 minutes each) of prolonged exposure therapy
Active Comparator: 2
Face-to-face (in person) psychotherapy
Behavioral: Prolonged exposure therapy
Twelve sessions (90 minutes each) of prolonged exposure therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158001

Contacts
Contact: Steven R Thorp, Ph.D. 619-400-5193 sthorp@ucsd.edu
Contact: Tania Zamora 858-552-8585 ext 5954 zamora.tania@gmail.com

Locations
United States, California
VA San Diego Healthcare System Recruiting
San Diego, California, United States, 92108
Contact: Steven R Thorp, Ph.D.    619-400-5193    sthorp@ucsd.edu   
Contact: Tania Zamora    858-552-8585 ext 3269    tania.zamora@va.gov   
Principal Investigator: Steven R Thorp, Ph.D.         
Sub-Investigator: Zia Agha, MD         
Sub-Investigator: Nilesh Shah, MD         
Sponsors and Collaborators
Veterans Medical Research Foundation
University of Pennsylvania
Investigators
Principal Investigator: Steven R. Thorp, PhD Veterans Affairs San Diego Healthcare System
  More Information

No publications provided

Responsible Party: Steven R. Thorp, PhD, Veterans Affairs San Diego Healthcare System
ClinicalTrials.gov Identifier: NCT01158001     History of Changes
Other Study ID Numbers: 080513, PT074431
Study First Received: February 20, 2009
Last Updated: December 1, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on August 18, 2014