Journal article
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)
Contemporary clinical trials, Vol.62, pp.105-113
11/2017
DOI: 10.1016/j.cct.2017.08.017
PMID: 28844986
Abstract
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.
Details
- Title: Subtitle
- 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)
- Creators
- Gabrielle H Saunders - National Center for Rehabilitative Auditory Research, VA Portland Health Care System, Portland, OR 97239, United StatesKousick Biswas - Cooperative Studies Program Coordinating Center, VA Maryland Health Care System, Perry Point, MD 21902, United StatesTracey Serpi - Cooperative Studies Program Coordinating Center, VA Maryland Health Care System, Perry Point, MD 21902, United StatesStephanie McGovern - James A Haley Veterans' Hospital, Tampa, FL 33612, United StatesShirley Groer - VA Office of Research and Development, Washington, DC 20420, United StatesEileen M Stock - Cooperative Studies Program Coordinating Center, VA Maryland Health Care System, Perry Point, MD 21902, United StatesKathryn M Magruder - Medical University of South Carolina, Charleston, SC 29425, United StatesDaniel Storzbach - VA Portland Health Care System, Portland, OR 97239, Unites StatesKelly Skelton - Atlanta VA Medical Center, Atlanta, GA, United StatesThad Abrams - Iowa City Veterans Affairs Health Care System, Iowa City, IA 52246, United StatesMark McCranie - National Center for Rehabilitative Auditory Research, VA Portland Health Care System, Portland, OR 97239, United StatesJoan Richerson - VA Tennessee Valley Health Care System, Nashville, TN 37212, United StatesPatricia A Dorn - VA Office of Research and Development, Washington, DC 20420, United StatesGrant D Huang - Cooperative Studies Program Central Office, VA Office of Research and Development, Washington, DC 20420, United StatesMichael T Fallon - Atlanta VA Medical Center, Atlanta, GA, United States
- Resource Type
- Journal article
- Publication Details
- Contemporary clinical trials, Vol.62, pp.105-113
- Publisher
- Elsevier Inc
- DOI
- 10.1016/j.cct.2017.08.017
- PMID
- 28844986
- ISSN
- 1551-7144
- eISSN
- 1559-2030
- Grant note
- name: Department of Veterans Affairs (VA); DOI: 10.13039/100007217, name: Veterans Health Administration; name: VA Office of Research and Development: Rehabilitation Research and Development Service
- Language
- English
- Date published
- 11/2017
- Academic Unit
- Psychiatry; General Internal Medicine; Internal Medicine
- Record Identifier
- 9984094326902771
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