PTSD Clinical Trial
Official title:
Veterans Telemedicine Outreach for PTSD Services
Post-Traumatic Stress Disorder (PTSD) is considered a major public health problem in the U.S. due to its high prevalence and high rates of disability associated with the disorder. For thousands of veterans, PTSD is a chronic disorder, resulting directly from military service that causes substantial psychological suffering and social disability. Barriers to PTSD care include poor access, mistrust, and lack of benefit from traditional treatments. This project addresses two very important and timely questions. First, can telemedicine be used as a tool to extend effective, specialized mental health services such as, cognitive processing therapy (CPT), to veterans with poor access to care? Second, does therapy delivered by telemedicine effect the quality of care in terms of clinical outcomes (PTSD severity, Quality of Life), and the quality of patient-therapist interaction (patient satisfaction & communication)? By answering these questions, this study will provide valuable knowledge for VA researchers, clinicians, and policy makers. The study findings will have direct implications related to making specific recommendations regarding telemedicine utilization to deliver specialized mental health services for veterans suffering from PTSD.
Anticipated Impact on Veterans' Healthcare: This project addresses two very important and
timely questions related to the VHA's mission to provide state of the art care to OEF and
OIF veterans. First, can telemedicine be used as a tool to extend effective, specialized
mental health services such as, cognitive processing therapy (CPT), to veterans with poor
access to care? Second, does therapy delivered by telemedicine effect the quality of care in
terms of clinical outcomes (PTSD severity, Quality of Life), and the quality of
patient-therapist interaction (patient satisfaction & communication)? By answering these
questions, this study will provide valuable knowledge for VA researchers, clinicians, and
policy makers. The study findings will have direct implications related to making specific
recommendations regarding telemedicine utilization to deliver specialized mental health
services for veterans suffering from PTSD.
Project Background/Rationale: Post-Traumatic Stress Disorder (PTSD) is considered a major
public health problem in the U.S. due to its high prevalence and high rates of disability
associated with the disorder. For thousands of veterans, PTSD is a chronic disorder,
resulting directly from military service that causes substantial psychological suffering and
social disability. Barriers to PTSD care include poor access, mistrust, and lack of benefit
from traditional treatments.
However, recently developed evidenced based treatments like CPT are very effective.
Unfortunately, these treatments are not widely available, as a large proportion of veterans
live in rural communities and have poor access to specialized mental health care. The VA
hospital system currently supports sophisticated telemedicine technology that can provide
CPT to veterans in their home communities. The proposed project will assess the quality of
CPT provided via telemedicine and its impact on outcomes, and is therefore, directly related
to the VA's mission to provide advanced, accessible, and high quality health care to all
eligible veterans regardless of place of residence: "Right care in the right place, at the
right time".
Project Objectives: The objective of the proposed study is to conduct a systematic
comparison of PTSD outcomes for veterans receiving cognitive processing therapy via
telemedicine vs. in-person care. The patient-therapist relationship is central in
establishing an effective therapeutic relationship and is strongly influenced by
communication. Consequently, this project will also compare provider-patient communication
during telemedicine consultations vs. in-person consultations.
Project Methods: We propose a randomized clinical trial of 254 patients receiving cognitive
processing therapy either via telemedicine or by in-person care. Telemedicine visits will
occur at La Jolla VA in San Diego and in-person visits will occur at the Mission Valley VA
Clinic in San Diego. Veterans with PTSD will be enrolled from the primary care and mental
health clinics at the above sites. Clinical services will be provided by 10 participating
providers with specialized training in CPT. Therapy will be provided over 12 weekly sessions
lasting 60 minutes each. Previously validated and widely used measures of PTSD symptom
severity (Clinician-Administered PTSD Scale, PTSD Checklist ) and health related quality of
life (SF-36) will be measured at baseline, at completion of therapy, and at 6 months
follow-up. In addition, we will measure and compare the quality of verbal and non-verbal
patient-provider communication for in-person and telemedicine visits via video recordings of
visits, which will be analyzed using the Roter Interaction Analyses System. Patient and
provider satisfaction will be measured post therapy with previously validated
questionnaires. Statistical methods will include descriptive analyses, reliability analyses,
and hypothesis testing using linear mixed models.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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