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

This study has been completed.
Sponsor:
Collaborators:
University of Pennsylvania
Information provided by (Responsible Party):
Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT01158001
First received: February 20, 2009
Last updated: June 22, 2015
Last verified: June 2015

February 20, 2009
June 22, 2015
May 2009
June 2012   (final data collection date for primary outcome measure)
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
  • Clinician-administered PTSD Scale (CAPS) diagnostic interview [ Time Frame: Pre-treatment, post-treatment, six-month follow-up ] [ Designated as safety issue: No ]
  • Neuropsychological testing battery to assess cognitive functioning [ Time Frame: Pre-treatment and post-treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01158001 on ClinicalTrials.gov Archive Site
  • 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)
  • 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. 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
  • PHQ-9 (self-reported depression) [ Time Frame: Pre-treatment; weekly during treatment; post-treatment; 6-month follow-up ] [ Designated as safety issue: Yes ]
  • PTSD Checklist (PCL; self-reported PTSD symptoms) [ Time Frame: Pre-treatment, weekly during treatment; post-treatment; and 6-month follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Telemedicine for Improved Delivery of Psychosocial Treatments for Post Traumatic Stress Disorder
Telemedicine for Improved Delivery of Psychosocial Treatments for Post Traumatic Stress Disorder

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Posttraumatic Stress Disorders
  • Depression
  • Anxiety
Behavioral: Prolonged exposure therapy
Twelve sessions (90 minutes each) of prolonged exposure therapy
  • Experimental: Psychotherapy via telemedicine
    In this arm, veterans received standard psychotherapy (prolonged exposure therapy) in a novel format - interacting with a therapist via videoconferencing.
    Intervention: Behavioral: 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.
    Intervention: Behavioral: Prolonged exposure therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
211
September 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01158001
080513, PT074431
No
Veterans Medical Research Foundation
Veterans Medical Research Foundation
  • Department of Defense
  • University of Pennsylvania
Principal Investigator: Steven R. Thorp, PhD Veterans Affairs San Diego Healthcare System
Veterans Medical Research Foundation
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP