Depression Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 211 |
Est. completion date | September 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | VA San Diego Healthcare System | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Veterans Medical Research Foundation | United States Department of Defense, University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinician-administered PTSD Scale (CAPS) diagnostic interview | Measure of PTSD diagnosis and severity | Pre-treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessment | No |
Secondary | PHQ-9 (self-reported depression) | Measure of depressive symptoms | Pre-treatment, weekly during 12 weeks of treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessment | Yes |
Secondary | PTSD Checklist (PCL; self-reported PTSD symptoms) | Measure of 17 posttraumatic stress disorder (PTSD) symptoms from specific event (PCL-S) | Pre-treatment, weekly during 12 weeks of treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessment | No |
Secondary | Neuropsychological testing battery to assess cognitive functioning | 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 |
Pre-treatment and post-treatment (14 weeks after pre-treatment assessment) | No |
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