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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, Baltimore2 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

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
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

入选标准

  • 未提供

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

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

  • Stress Biomarkers: Alpha Amylase(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: IgA(Baseline, 8 weeks)
  • Psychosocial Health: Quality of Individual's Relationships(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: Positive Affect(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 (2)

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