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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Posttraumatic Stress Disorders, Depression, Anxiety

Intervention / Treatment
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* Behavioral: Prolonged exposure therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychotherapy via telemedicine<br>In this arm, veterans received standard psychotherapy (prolonged exposure therapy) in a novel format - interacting with a therapist via videoconferencing. | Behavioral: Prolonged exposure therapy<br>* Twelve sessions (90 minutes each) of prolonged exposure therapy<br>|
| Active Comparator: Face-to-face (in person) psychotherapy<br>In this arm, veterans received standard psychotherapy (prolonged exposure therapy) in the traditional format - in person with a therapist. | Behavioral: Prolonged exposure therapy<br>* Twelve sessions (90 minutes each) of prolonged exposure therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic stress disorders, Telemedicine, Psychotherapy, Neuropsychological test, Depression