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

Tracking Information
First Submitted Date ICMJE	February 20, 2009
First Posted Date ICMJE	July 8, 2010
Last Update Posted Date	June 24, 2015
Study Start Date ICMJE	May 2009
Actual Primary Completion Date	June 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 22, 2015)	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
Original Primary Outcome Measures ICMJE; (submitted: July 6, 2010)	Clinician-administered PTSD Scale (CAPS) diagnostic interview [ Time Frame: Pre-treatment, post-treatment, six-month follow-up ]; Neuropsychological testing battery to assess cognitive functioning [ Time Frame: Pre-treatment and post-treatment ]
Change History	Complete list of historical versions of study NCT01158001 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 22, 2015)	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
Original Secondary Outcome Measures ICMJE; (submitted: July 6, 2010)	PHQ-9 (self-reported depression) [ Time Frame: Pre-treatment; weekly during treatment; post-treatment; 6-month follow-up ]; PTSD Checklist (PCL; self-reported PTSD symptoms) [ Time Frame: Pre-treatment, weekly during treatment; post-treatment; and 6-month follow-up ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Telemedicine for Improved Delivery of Psychosocial Treatments for Post Traumatic Stress Disorder
Official Title ICMJE	Telemedicine for Improved Delivery of Psychosocial Treatments for Post Traumatic Stress Disorder
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Posttraumatic Stress Disorders; Depression; Anxiety
Intervention ICMJE	Behavioral: Prolonged exposure therapy; Twelve sessions (90 minutes each) of prolonged exposure therapy
Study Arms	Experimental: Psychotherapy via telemedicine In this arm, veterans received standard psychotherapy (prolonged exposure therapy) in a novel format - interacting with a therapist via videoconferencing. Intervention: Behavioral: Prolonged exposure therapy; 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. Intervention: Behavioral: Prolonged exposure therapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 22, 2015)	211
Original Estimated Enrollment ICMJE; (submitted: July 6, 2010)	254
Actual Study Completion Date	September 2012
Actual Primary Completion Date	June 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01158001
Other Study ID Numbers ICMJE	080513; PT074431
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Veterans Medical Research Foundation
Study Sponsor ICMJE	Veterans Medical Research Foundation
Collaborators ICMJE	United States Department of Defense; University of Pennsylvania
Investigators ICMJE	Principal Investigator: Steven R. Thorp, PhD Veterans Affairs San Diego Healthcare System
PRS Account	Veterans Medical Research Foundation
Verification Date	June 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP