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
Recruitment status was Recruiting
Sponsor:
Veterans Medical Research Foundation
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
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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 ]
- Wechsler Test of Adult Reading
- Rey Complex Figure task
- California Verbal Learning Test
- Wisconsin Card Sort Test
- WAIS Digit Span
- D-KEFS Verbal Fluency
- D-KEFS Color-Word Interference
- 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
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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
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:
|
Depression Depressive Disorder Disease Stress Disorders, Post-Traumatic Stress Disorders, Traumatic |
Anxiety Disorders Behavioral Symptoms Mental Disorders Mood Disorders Pathologic Processes |
ClinicalTrials.gov processed this record on February 25, 2015