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临床试验/NCT04832815
NCT04832815进行中(未招募)不适用

Equine Human Interaction With Veterans

VA Salt Lake City Health Care System2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年12月19日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
2
主要终点
Mean Difference in Acceptance and Action Questionnaire-II (AAQII) among the Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program

研究概览

简要总结

This study has two components. The first component (Aim 1) is a randomized trial of a novel equine therapy intervention that was developed for research purposes. The second component (Aim 2) is an evaluation of outcomes from Veterans participating in an adaptive horsemanship program that is not conducted for research purposes.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Currently enrolled for services at the VA Salt Lake City Health Care System
  • At least one mental health service encounter within the preceding 12 months
  • Diagnosed with PTSD by a clinician within the preceding 24 months
  • Have a doctor release to participate in equine activities
  • Currently enrolled for services at the VA Salt Lake City Health Care System
  • Have a doctor release to participate in equine activities

排除标准

  • Pregnancy
  • Diagnoses of a psychotic spectrum illness and/or cognitive impairment
  • Physical disability that would prevent horseback riding
  • Weight >= 250 lbs.
  • Potentially the severity of and psychological and/or behavioral symptoms will be considered

结局指标

主要结局

Mean Difference in Acceptance and Action Questionnaire-II (AAQII) among the Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program

时间窗: through study completion, an average of 2 years

AAQII measures psychological flexibility. The total AAQII score can range from 7 to 49, with higher values indicating greater psychological inflexibility. Mixed Effect Modeling will be used for the analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate the outcome at multiple time points: pre-intervention, post-intervention for selected or all sessions, and post-intervention.

Mean Difference in Positive and Negative Affect Scale (PANAS) among the Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program

时间窗: through study completion, an average of 2 years

PANAS measures short-term positive and negative emotions. The total PANAS-C score can range from 12 to 60 for the positive affect (PA) scale, with higher values indicating greater PA. Similarly, the score range from 15 to 75 for the negative affect (NA) scale, with higher values indicating greater NA. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate the primary outcome at multiple time points: pre-intervention, post-intervention sessions, and post-intervention.

Mean Difference in Beck Depression Inventory (BDI) for Equine Therapy + TAU cohort compared to the TAU only cohort

时间窗: through study completion, an average of 2 years

BDI measures depressive symptoms. The total BDI score can range from 0 to 63, with higher values indicating greater depressive symptoms. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention.

Mean Difference in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) for Horsemanship Skills Training Program and for Equine Therapy + TAU cohort compared to the TAU only cohort

时间窗: through study completion, an average of 2 years

Q-LES-Q-SF measures quality of, and satisfaction with, life. The total Q-LES-Q-SF score can range from 14 to 70, with higher values indicating greater satisfaction. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention.

Heart Rate (HR) Indices

时间窗: through study completion, an average of 2 years

To determine correlations between physiological responses of the rider and horse, the following heart rate (HR) indices will be computed: Mean HR, standard deviation of the beat-to-beat intervals (SDRR) and the root mean square of successive beat-to-beat differences (rMSSD). Both SDRR and rMSSD are measures of HR variability and reflect shifts between sympathetic (e.g., decrease in HR variability) or parasympathetic (e.g., increase in HR variability) drive. These measures will be taken during each equine intervention session.

Mean Difference in Five Facet Mindfulness Questionnaire (FFMQ) for Horsemanship Skills Training Program.

时间窗: through study completion, an average of 2 years

The total FFMQ score can range from 8 to 40 for each of the facets (observe, describe, act aware, nonjudge, nonreact), with higher values indicating greater levels of mindfulness. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention.

Mean and Standard Deviation of Personal Satisfaction Program Survey for Horsemanship Skills Training Program and for Equine Therapy + TAU cohort compared to the TAU only cohort

时间窗: through study completion, an average of 2 years

Personal Satisfaction Program Survey measures satisfaction with the program. The total Personal Satisfaction Program Survey score can range from 0 to 210, with higher values indicating greater program satisfaction. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention.

Mean Difference in Physical Activity Enjoyment Scale (PACES) for Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program

时间窗: through study completion, an average of 2 years

PACES measures enjoyment of activity. The total PACES score can range from 18 to 126, with higher values indicating greater enjoyment. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate the outcome after the intervention sessions and post-intervention.

Mean Difference in Toronto Mindfulness Scale (TMS) for Equine Therapy + TAU cohort

时间窗: through study completion, an average of 2 years

TMS measures state mindfulness. The total TMS score can range from 0 to 52, with higher values indicating greater state mindfulness. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome pre-intervention, post-intervention sessions, post-intervention.

Mean Difference in Posttraumatic Stress Disorder Checklist (PCL) for Equine Therapy + TAU cohort compared to the TAU only cohort

时间窗: through study completion, an average of 2 years

PCL measures PTSD symptoms. The total PCL score can range from 17 to 85, with higher values indicating greater PTSD symptoms. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention.

次要结局

  • Mean and Standard Deviation of Demographic information including medical and psychiatric diagnoses(through study completion, an average of 2 years)

研究者

发起方
VA Salt Lake City Health Care System
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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