TY - JOUR
T1 - Issues in the design of a randomized noninferiority clinical trial of telemental health psychotherapy for rural combat veterans with PTSD
AU - Morland, Leslie A.
AU - Greene, Carolyn J.
AU - Rosen, Craig
AU - Mauldin, Patrick D.
AU - Frueh, B. Christopher
N1 - Funding Information:
This work is partially supported by Grant PT074516 from the Department of Defense. This work is also supported by the Office of Research and Development, Medical Research Service, Department of Veterans Affairs. All views and opinions expressed herein are those of the authors and do not necessarily reflect those of our respective institutions or the Department of Veterans Affairs.
PY - 2009/11
Y1 - 2009/11
N2 - This methodological article provides a description of the design, methods, and rationale of the first prospective, noninferiority designed randomized clinical trial evaluating the clinical and cost implications of delivering an evidence-based cognitive-behavioral group intervention specifically treating posttraumatic stress disorder (PTSD) with a trauma-focused intervention via video teleconferencing (VTC). PTSD is a prevalent mental health problem found among returning Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) military populations. These returning military personnel often live in rural areas and therefore have limited access to care and specialized psychological treatments. In the field of mental health, telemental health (TMH) technology has introduced a potential solution to the persistent problem of access to care in remote areas. This study is enrolling approximately 126 returning veterans with current combat-related PTSD who are receiving services through the Veteran Administration (VA) mental health care clinics on 4 Hawaiian Islands. Cognitive Processing Therapy (CPT), an empirically supported manualized treatment for PTSD, is being delivered across 9 cohorts. Participants are assigned to either the experimental VTC condition or the in-person control condition. Assessments measuring clinical, process, and cost outcomes are being conducted at baseline, mid-treatment, post-treatment, and 3 and 6 months post-treatment. The study employs a noninferiority design to determine if the group treatment delivered via VTC is as good as the traditional in-person modality. In addition, a cost analysis will be performed in order to compare the cost of the 2 modalities. Novel aspects of this trial and specific challenges are discussed.
AB - This methodological article provides a description of the design, methods, and rationale of the first prospective, noninferiority designed randomized clinical trial evaluating the clinical and cost implications of delivering an evidence-based cognitive-behavioral group intervention specifically treating posttraumatic stress disorder (PTSD) with a trauma-focused intervention via video teleconferencing (VTC). PTSD is a prevalent mental health problem found among returning Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) military populations. These returning military personnel often live in rural areas and therefore have limited access to care and specialized psychological treatments. In the field of mental health, telemental health (TMH) technology has introduced a potential solution to the persistent problem of access to care in remote areas. This study is enrolling approximately 126 returning veterans with current combat-related PTSD who are receiving services through the Veteran Administration (VA) mental health care clinics on 4 Hawaiian Islands. Cognitive Processing Therapy (CPT), an empirically supported manualized treatment for PTSD, is being delivered across 9 cohorts. Participants are assigned to either the experimental VTC condition or the in-person control condition. Assessments measuring clinical, process, and cost outcomes are being conducted at baseline, mid-treatment, post-treatment, and 3 and 6 months post-treatment. The study employs a noninferiority design to determine if the group treatment delivered via VTC is as good as the traditional in-person modality. In addition, a cost analysis will be performed in order to compare the cost of the 2 modalities. Novel aspects of this trial and specific challenges are discussed.
KW - Military veterans
KW - Noninferiority trial
KW - Posttraumatic stress disorder (PTSD)
KW - Rural
KW - Telemedicine
UR - http://www.scopus.com/inward/record.url?scp=70350569221&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=70350569221&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2009.06.006
DO - 10.1016/j.cct.2009.06.006
M3 - Article
C2 - 19576299
AN - SCOPUS:70350569221
VL - 30
SP - 513
EP - 522
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
SN - 1551-7144
IS - 6
ER -