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)

Contemp Clin Trials. 2017 Nov;62:105-113. doi: 10.1016/j.cct.2017.08.017. Epub 2017 Aug 26.

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.

Keywords: Emotional support dog; Post-traumatic; Quality of life; Service animal; Service dog; Stress disorders.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Animal Assisted Therapy / methods*
  • Animals
  • Dogs
  • Female
  • Humans
  • Male
  • Mental Health
  • Middle Aged
  • Quality of Life
  • Research Design
  • Stress Disorders, Post-Traumatic / therapy*
  • United States
  • United States Department of Veterans Affairs
  • Veterans / psychology*
  • Young Adult