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
  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


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)

  • 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


Enrollment: 211
Study Start Date: May 2009
Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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

Locations
United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92108
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: Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01158001     History of Changes
Other Study ID Numbers: 080513, PT074431
Study First Received: February 20, 2009
Last Updated: June 22, 2015
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:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 27, 2015