Effects of an Animal Assisted Mindfulness Intervention for Patients With Acquired Brain Injury: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- General psychological distress
研究概览
简要总结
The aim of this study is to investigate the effect of an animal assisted mindfulness intervention (AAMI) on patients with acquired brain injuries on their global severity of psychological distress.
In addition, the effects on the patients' symptoms of depression, anxiety, perceived stress, mood, coping and mindfulness/self-compassion will be assessed.
The study experimental condition consists of 6 weeks of intervention, containing 6 different modules. In every session, an animal will be present.
In the control condition, the same program and same exercises will be used without the presence of or reference to animals. Sessions take place two times a week for 6 weeks (leading up to a total of 12 experimental/control sessions), each lasting for about 60 minutes.
24 participants are planned to be included, 12 patients in each group.
详细描述
It was estimated that a total sample of 24 participants (12 patients in each group) would provide enough power to detect a medium effect. Since we had several dropouts, two additional groups (one intervention and one control) were started. This lead to the inclusion of 31 participants with a total sample size of 25 participants finishing the program.
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
- Single (Outcomes Assessor)
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
- •Patients of REHAB Basel
- •Acquired Brain Injury (ABI); FIM (Functional Independence Measure) cut-off score defined as > 60
- •Depressive or/and anxiety symptoms
- •Psychological difficulties coping with the actual life situation
- •18 years or older
- •Willing to work with therapy animals
- •German speaking
- •Willingness to participate/informed consent
排除标准
- •Communication and articulation is not possible
- •Allergy to animals
- •Aversion against animals
- •Schizophrenic-related comorbidity
- •Mobilization to "Therapietiergarten" not possible
结局指标
主要结局
General psychological distress
时间窗: 11 weeks
Measured via BSI (Global Severity Index GSI). The Global Severity Index (GSI) is designed to help quantify a patient's severity-of-illness and provides a single composite score for measuring the outcome of a treatment program based on reducing symptom severity. Minimal total score = 0, maximal total score = 212 (higher values represent a worse outcome)
次要结局
- Depression(11 weeks)
- Self-compassion(11 weeks)
- Coping(11 weeks)
- Perceived Stress(11 weeks)
- Mindfulness(11 weeks)
- Visual Analogue Scale (VAS)(11 weeks)
- Mood(6 weeks)