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临床试验/NCT03882619
NCT03882619已完成不适用

Effectiveness of Using Calligraphic Activity to People With Schizophrenia

The Hong Kong Polytechnic University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年4月1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
150
试验地点
2
主要终点
Changes in emotion

研究概览

简要总结

To examine the effects of calligraphy activity on symptoms, attention, emotion, and quality of life in people with schizophrenia. We hypothesized that through a six-month intervention using calligraphy activity, people with schizophrenia will have their symptoms decreased, attention improved, emotion enhanced, and quality of life increased. This study will adopt single-blind, randomized controlled trial, and 160 people with schizophrenia will be recruited in this study. They will be randomly assigned to either a calligraphy activity group (treatment group; n=80) or an occupational activity group (control group; n=80). Participants will complete assessments at pretest, posttest, and 3-month follow-up using the following instruments: Positive and Negative Syndrome Scale (PANSS), Chu's Attention Test, The Taiwanese version of Montreal Cognitive Assessment (MoCA-T), WHO questionnaire on the Quality of Life, Brief Form (WHOQOL-BREF), and Chinese Depression Anxiety Stress Scales(DASS21).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Inpatients
  • With diagnosis of schizophrenia or schizoaffective disorder
  • Not in acute stage
  • Voluntarily participate

排除标准

  • Severe cognition level or intellectual disability that prevent from participation
  • Severe behavioral problems and symptoms that prevent from participation
  • People with blindness

结局指标

主要结局

Changes in emotion

时间窗: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline

Emotion is assessed using self-report of Chinese Depression Anxiety Stress Scale. The scale includes three subscales: depression (score range 0-21; higher score indicates higher depression), anxiety (score range 0-21; higher score indicates higher anxiety), and stress (score range 0-21; higher score indicates higher stress).

Changes in attention

时间窗: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline

Attention is assessed using Chu's Attention Test. The test contains 200 items and is assessed in 10 minutes with two scores calculated: correct number (answered number-number of error answer); rate of correct number (correct number divided by answered number). Higher scores in correct number and rate of correct number indicate better attention.

Changes in syndrome

时间窗: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline

Symptoms are assessed using Positive and Negative Syndrome Scale. The scale includes three subscales: positive symptom (score range 7-49; higher score indicates more positive symptoms), negative symptoms (score range 7-49; higher score indicates more negative symptoms), and general psychopathology (score range 16-112; higher score indicates more general symptoms).

Changes in cognition

时间窗: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline

Cognition is assessed using Taiwanese version of Montreal Cognitive Assessment. The score range of the scale is between 0 and 30, a higher score indicates better cognition.

Changes in quality of life

时间窗: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline

Quality of life is assessed using WHO questionnaire on the Quality of Life, Brief Form. The scale includes four subscales: physical (score range 4-20; higher score indicates better physical quality of life); psychological (score range: 4-20; higher score indicates better psychological quality of life); social (score range: 4-20; higher score indicates better social quality of life); environment (score range: 4-20; higher score indicates better environment quality of life).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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