on the Daily Activity, Sleep Pattern, and Stress Level of Military Veterans With PTSD
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Heart rate variability
研究概览
简要总结
The study aims to investigate the effects of a service dog on military veterans with post traumatic stress syndrome (PTSD). The investigators will use non-invasive measures of the physiological responses, data obtained via dairy keeping, accelerometer data estimating activity and sleep patterns, and baseline information including psychological measures validated for this specific population.
详细描述
The investigators will measure and compare the immediate effect of the presence of the dog, on days with low stress and high stress, using non-invasive measures of the physiological response, diary notes, and data on activity and sleep pattern The latter will also be collected for the service dogs. The investigators will apply a cross-sectional design. The participants will be divided into two groups based on whether they own a certified service dog (treatment group) or are on a waitlist for a service dog (control group).
The experimental period will consist of a 14-day period. In the preceding week the participants receive a visit, where they will be given instructions to fill in a diary, how to collect and store saliva samples, and use equipment for data collection. In the diary they record their daily activities and any situation perceived to be stressful during the experimental period. In the experimental period, the participants will wear an accelerometer. Every second day, the particpants will wear equipment measuring their heart rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Have been deployed in a war zone
- •Fulfil criteria for PTSD
- •Fulfil criteria for receiving a certified service dog
- •If having a service dog, they must have owned the dog for more than 6 months, and the dog must be at leat 2 years of age
排除标准
- •Use of alcohol or drugs to an extent that it affects the ability to attend to ordinary daily activities
结局指标
主要结局
Heart rate variability
时间窗: Day 14 of the experimental period
Heart rate variability is calculated from heart rate data
Blood pressure
时间窗: Day 14 of the experimental period at 8 p.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Dairy notes regarding stressful events
时间窗: Day 14 of the experimental period
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Daily activity pattern
时间窗: In the experimental period, which is 14 days
Daily activity pattern measured with a wrist-worn accelerometer
Salivary, Cortisol
时间窗: Day 14 of the experimental period at 8 p.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Heart rate
时间窗: Day 14 of the experimental period
The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively
Sleep pattern
时间窗: In the experimental period, which is 14 days
Sleep pattern measured with a wrist-worn accelerometer
次要结局
未报告次要终点