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

Primary Purpose

Posttraumatic Stress Disorders, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolonged exposure therapy
Sponsored by
Veterans Medical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorders focused on measuring Posttraumatic stress disorders, Telemedicine, Psychotherapy, Neuropsychological test, Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA San Diego Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Psychotherapy via telemedicine

Face-to-face (in person) psychotherapy

Arm Description

In this arm, veterans received standard psychotherapy (prolonged exposure therapy) in a novel format - interacting with a therapist via videoconferencing.

In this arm, veterans received standard psychotherapy (prolonged exposure therapy) in the traditional format - in person with a therapist.

Outcomes

Primary Outcome Measures

Clinician-administered PTSD Scale (CAPS) diagnostic interview
Measure of PTSD diagnosis and severity

Secondary Outcome Measures

PHQ-9 (self-reported depression)
Measure of depressive symptoms
PTSD Checklist (PCL; self-reported PTSD symptoms)
Measure of 17 posttraumatic stress disorder (PTSD) symptoms from specific event (PCL-S)
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

Full Information

First Posted
February 20, 2009
Last Updated
June 22, 2015
Sponsor
Veterans Medical Research Foundation
Collaborators
United States Department of Defense, University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01158001
Brief Title
Telemedicine for Improved Delivery of Psychosocial Treatments for Post Traumatic Stress Disorder
Official Title
Telemedicine for Improved Delivery of Psychosocial Treatments for Post Traumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Veterans Medical Research Foundation
Collaborators
United States Department of Defense, University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorders, Depression, Anxiety
Keywords
Posttraumatic stress disorders, Telemedicine, Psychotherapy, Neuropsychological test, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychotherapy via telemedicine
Arm Type
Experimental
Arm Description
In this arm, veterans received standard psychotherapy (prolonged exposure therapy) in a novel format - interacting with a therapist via videoconferencing.
Arm Title
Face-to-face (in person) psychotherapy
Arm Type
Active Comparator
Arm Description
In this arm, veterans received standard psychotherapy (prolonged exposure therapy) in the traditional format - in person with a therapist.
Intervention Type
Behavioral
Intervention Name(s)
Prolonged exposure therapy
Intervention Description
Twelve sessions (90 minutes each) of prolonged exposure therapy
Primary Outcome Measure Information:
Title
Clinician-administered PTSD Scale (CAPS) diagnostic interview
Description
Measure of PTSD diagnosis and severity
Time Frame
Pre-treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessment
Secondary Outcome Measure Information:
Title
PHQ-9 (self-reported depression)
Description
Measure of depressive 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
Title
PTSD Checklist (PCL; self-reported PTSD symptoms)
Description
Measure of 17 posttraumatic stress disorder (PTSD) symptoms from specific event (PCL-S)
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
Title
Neuropsychological testing battery to assess cognitive functioning
Description
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
Time Frame
Pre-treatment and post-treatment (14 weeks after pre-treatment assessment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R. Thorp, PhD
Organizational Affiliation
Veterans Affairs San Diego Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States

12. IPD Sharing Statement

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

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