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

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.
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Behavioral: Prolonged exposure therapy
Twelve sessions (90 minutes each) of prolonged exposure therapy
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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.
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Behavioral: Prolonged exposure therapy
Twelve sessions (90 minutes each) of prolonged exposure therapy
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- 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
- 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
- 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)
- Neuropsychological testing battery to assess cognitive functioning [ Time Frame: Pre-treatment and post-treatment (14 weeks after pre-treatment assessment) ]
- Wechsler Test of Adult Reading
- Rey Complex Figure task
- California Verbal Learning Test
- Wisconsin Card Sort Test
- Wechsler Adult Intelligence Scale Digit Span
- Delis-Kaplan Executive Functioning System (D-KEFS) Verbal Fluency
- Delis-Kaplan Executive Functioning System (D-KEFS) Color-Word Interference
- Delis-Kaplan Executive Functioning System (D-KEFS) Trails

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

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
United States, California | |
VA San Diego Healthcare System | |
San Diego, California, United States, 92108 |
Principal Investigator: | Steven R. Thorp, PhD | Veterans Affairs San Diego Healthcare System |
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 |