Design and challenges for a randomized, multi-site clinical trial comparing the use of service dogs and emotional support dogs in Veterans with post-traumatic stress disorder (PTSD).

Autor: Saunders GH; National Center for Rehabilitative Auditory Research, VA Portland Health Care System, Portland, OR 97239, United States. Electronic address: gabrielle.saunders@va.gov., Biswas K; Cooperative Studies Program Coordinating Center, VA Maryland Health Care System, Perry Point, MD 21902, United States., Serpi T; Cooperative Studies Program Coordinating Center, VA Maryland Health Care System, Perry Point, MD 21902, United States., McGovern S; James A Haley Veterans' Hospital, Tampa, FL 33612, United States., Groer S; VA Office of Research and Development, Washington, DC 20420, United States., Stock EM; Cooperative Studies Program Coordinating Center, VA Maryland Health Care System, Perry Point, MD 21902, United States., Magruder KM; Medical University of South Carolina, Charleston, SC 29425, United States., Storzbach D; VA Portland Health Care System, Portland, OR 97239, Unites States., Skelton K; Atlanta VA Medical Center, Atlanta, GA, United States., Abrams T; Iowa City Veterans Affairs Health Care System, Iowa City, IA 52246, United States; University of Iowa, Iowa City, IA 52246, United States., McCranie M; National Center for Rehabilitative Auditory Research, VA Portland Health Care System, Portland, OR 97239, United States., Richerson J; VA Tennessee Valley Health Care System, Nashville, TN 37212, United States., Dorn PA; VA Office of Research and Development, Washington, DC 20420, United States., Huang GD; Cooperative Studies Program Central Office, VA Office of Research and Development, Washington, DC 20420, United States., Fallon MT; Atlanta VA Medical Center, Atlanta, GA, United States.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2017 Nov; Vol. 62, pp. 105-113. Date of Electronic Publication: 2017 Aug 26.
DOI: 10.1016/j.cct.2017.08.017
Abstrakt: Posttraumatic stress disorder (PTSD) is a leading cause of impairments in quality of life and functioning among Veterans. Service dogs have been promoted as an effective adjunctive intervention for PTSD, however published research is limited and design and implementation flaws in published studies limit validated conclusions. This paper describes the rationale for the study design, a detailed methodological description, and implementation challenges of a multisite randomized clinical trial examining the impact of service dogs on the on the functioning and quality of life of Veterans with PTSD. Trial design considerations prioritized participant and intervention (dog) safety, selection of an intervention comparison group that would optimize enrollment in all treatment arms, pragmatic methods to ensure healthy well-trained dogs, and the selection of outcomes for achieving scientific and clinical validity in a Veteran PTSD population. Since there is no blueprint for conducting a randomized clinical trial examining the impact of dogs on PTSD of this size and scope, it is our primary intent that the successful completion of this trial will set a benchmark for future trial design and scientific rigor, as well as guiding researchers aiming to better understand the role that dogs can have in the management of Veterans experiencing mental health conditions such as PTSD.
(Published by Elsevier Inc.)
Databáze: MEDLINE
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