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临床试验/NCT04476836
NCT04476836Unknown不适用

Animal-Assisted Therapy in Middle-aged and Older Patients With Schizophrenia

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Change scores of Positive and Negative Syndrome Scale

研究概览

简要总结

Animal-assisted therapy (AAT) can be helpful to improve the psychiatric, emotional, physical,and social status in patients with physical and mental illness and the elderly.

The study aims to investigate the effects of AAT program in middle-aged and older patients with schizophrenia. The investigators will recruit 40 patients with schizophrenia in psychiatric ward randomised into AAT group and control group. AAT group will complete the 12-week program. This study contains two assessment sessions before and after intervention, including PANSS, ACIS, MoCA-T, CHI, DASS-21, CST, TUG and 5MWT.

详细描述

Animal-assisted therapy (AAT) can be helpful to improve the outcomes of psychiatric and emotional symptoms, physical activeness, social skills, well-beings in patients with physical and mental illness and the elderly.

The study aims to assess the applications and outcomes of psychiatric symptoms, social skills, cognitive function, well-beings, emotional status and physical fitness of AAT program applied to middle-aged and older patients with chronic schizophrenia.

The investigators will recruit 40 patients with chronic schizophrenia who were admitted to day care ward and rehabilitation ward, and conduct a randomized, controlled study. 40 patients will be stratified by the ward into AAT group and control group. AAT group will complete the 12-week program. This study contains two assessment sessions completed within one week before and after 12-week program. Subjects will be evaluated by the PANSS, ACIS, MoCA-T, CHI, DASS-21, CST, TUG and 5MWT in both sessions. Statistical analysis is examined using paired t-test to see whether there is a significant difference (based on p-value) between the scores of two assessment sessions in the AAT and control group, and using independent t-test to see whether there is a significant difference in the change scores of two assessment sessions between the 2 groups.

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 (Investigator)

入排标准

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

入选标准

  • Having a diagnosis of schizophrenia according to the DSM-
  • Adult aged 40 years or older.
  • Having stable physical and psychological health conditions based on master clinician judgment.
  • Having the will to participate in the study after thorough comprehension of the content.
  • Not receiving treatment protocol last half a year.

排除标准

  • Severe cognitive impairment e.g. aphasia, being unable to follow 3 or more orders.
  • Being allergic to animals.
  • History of Asthma.
  • Coagulation disorders
  • presenting symptoms of specific phobia, anxiety disorder and obsessive-compulsive disorder in context of dog, infection and contamination.

结局指标

主要结局

Change scores of Positive and Negative Syndrome Scale

时间窗: Baseline, immediate after treatment

This test is used for measuring symptom severity of patients with schizophrenia.

次要结局

  • Change scores of The Assessment of Communication and Interaction Skills(Baseline, immediate after treatment)
  • Change scores of The Taiwanese version of Montreal Cognitive Assessment(Baseline, immediate after treatment)
  • Change scores of Depression Anxiety Stress Scales-21(Baseline, immediate after treatment)
  • Change scores of Timed Up and Go(Baseline, immediate after treatment)
  • Change scores of Chinese Happiness Inventory(Baseline, immediate after treatment)
  • Change scores of Chair Stand Test(Baseline, immediate after treatment)
  • Change scores of The 5-Meter Walk Test(Baseline, immediate after treatment)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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