跳至主要内容
临床试验/NCT03777020
NCT03777020已完成不适用

Evaluating the Efficacy of a Service Dog Training Program for Military Veterans With PTSD

University of Maryland, Baltimore1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年8月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Post Traumatic Stress Symptom Severity

研究概览

简要总结

Post-traumatic stress disorder (PTSD), an invisible wound of war, affects approximately 20%1 of the 18.5 million U.S. veterans and places them at higher risk for impaired biopsychosocial functioning. PTSD symptom severity (PTSDSS) is significantly correlated with stress and psychosocial consequences of inability to regulate emotions, control impulsive behaviors, and function within family and society. Alarming veteran PTSD rates and its insidious effects demand empirically validated treatment programs. More than a million veterans receive new diagnoses of each year. VA PTSD therapy programs reach only 1% of veterans. Nearly 35% of veterans do not respond to widely used psychotherapy and pharmacotherapy treatments. Training a service dog (SD) is a novel rehabilitative animal-assisted intervention that shows promise in other populations. This project evaluates the efficacy of a service dog training program (SDTP) as an alternative and adjunctive treatment and rehabilitative option for veterans with PTSD.

详细描述

Veterans with PTSD attend 8 weekly sessions of either training a service dog or learning about how to train a dog at the Warrior Canine Connection facility in Boyds MD. They complete questionnaires prior to the start of the program and at the midpoint (after 4 sessions) and end of the program (after 8 sessions). Participants also wear a monitor to record heart rate variability during the 1st, 4th, and 8th sessions and provide saliva samples at these same times.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Accepted into the Warrior Canine Connection Service Dog Training Program. Their inclusion criteria are:
  • •military veteran;
  • •diagnosis of PTSD;
  • •able to give informed consent; and
  • •able to understand English; And
  • •Military Veteran

排除标准

  • •Excluded from the Warrior Canine Connection Service Dog Training Program. Their criteria are:
  • •fear of dogs;
  • •allergy to pet dander;
  • •active substance abuse;
  • •active psychosis, or
  • •history of animal abuse
  • •Excluded by the WCC from participation in their Service Dog Training Program because they have:
  • •fear of dogs; allergy to pet dander; active substance abuse; active psychosis, history of animal abuse or physically unable to complete tasks required to train dogs

研究组 & 干预措施

Service Dog Training Program (SDTP)

Experimental

Veterans randomized to the SDTP will be paired with an experienced Warrior Canine Connection (WCC) Mission Based Trauma Recovery (MBTR)-Trainer (MBRT-T) and a service dog (SD). One hour training modules will be scheduled once a week for 8 weeks. Participants will come to WCC for all the weekly training modules. Participants will be paired with the same SD for the duration of the SDTP unless an unforeseen circumstance arises and the SD needs to be removed from the SDTP. The MBTR-T will deliver the prescribed SDTP modules created by WCC. Each session will be fully supervised by a WCC MBTR-T to address any concerns or safety issues that may arise.

干预措施: Service Dog Training Program (Behavioral)

Dog Training Education

Other

Veterans randomized to Dog Training Education will participate in one hour online SD training modules (https://e-trainingfordogs.com) scheduled once a week for 8 weeks. The online training modules are delivered by experienced SD trainers and will employ parallel content to the WCC SDTP. Participants will come to the WCC site for all the weekly online training modules. Members of the WLCI group will have education about dog training, but NO interaction with a SD. The online training modules for the DTE group are intended to keep the veterans who are not immediately assigned to the SDTP engaged in the study. They will participate in the SDTP after conclusion of participation in the 8 week study.

干预措施: Dog Training Education (Other)

结局指标

主要结局

Post Traumatic Stress Symptom Severity

时间窗: Baseline, 8 weeks

Post traumatic stress disorder checklist for DSM-5 range of scores 0-80; higher score is worse (more PTSD)

次要结局

  • Psychosocial Health: Quality of Individual's Relationships(Baseline, 8 weeks)
  • Psychosocial Health: Positive Affect(Baseline, 8 weeks)
  • Stress Biomarker Markers:Cortisol(Baseline, 8 weeks)
  • Stress Biomarkers: HRV(baseline, 8 weeks)
  • Psychosocial Health: Resilience(Baseline, 8 weeks)
  • Psychosocial Health: Relationship With Friends and Family(Baseline, 8 weeks)
  • Stress Biomarkers: Alpha Amylase(Baseline, 8 weeks)
  • Stress Biomarkers: IgA(Baseline, 8 weeks)
  • Psychosocial Health: Satisfaction With Social Activities(Baseline, 8 weeks)
  • Psychosocial Health: Companionship(Baseline, 8 weeks)
  • Psychosocial Health: Anxiety(baseline, 8 weeks)
  • Stress Marker: Perceived Stress(Baseline, 8 weeks)
  • Psychosocial Health: Health Related Quality of Life(Baseline, 8 weeks)
  • Psychosocial Health:Depression(baseline, 8 weeks)
  • Psychosocial Health: Suicidal Ideation(Baseline, 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erika Friedmann

Professor

University of Maryland, Baltimore

研究点 (1)

Loading locations...

相似试验