The Effectiveness and Mechanism of Character Strengths-based Structured Treatment and Education Programme on Rehabilitation of Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Change from Baseline Depression at 1 month. Hamilton Depression Scale (HAMD-24) Scale
研究概览
简要总结
There is an urgent need for educational and psychological adjustment to stimulate the post-stroke patients' motivation to actively carry out rehabilitation. Studies have shown that interventions based on character strengths are widely used in chronic disease patients abroad, and have achieved the effect of improving the physical and mental health. However, research on individualized character strengths in stroke patient intervention is limited, and more clinical evidence is needed. This study is based on personality theory and the application of character strengths-based STEP programme (CSSTEP) in stroke patients. The investigators hypothesized that the CSSTEP programme could help stroke patients to improve mental state, cognitive function, and better gait performance, suffer from less post-stroke depression, enhance their post-stroke self-confidence.
详细描述
Post-stroke patients are often accompanied by different degrees of cognitive and language impairments. About 45% of the patients have persistent limb dysfunction, which leads to strong psychological stress reactions in patients, and negative emotions such as anxiety and depression are common. There is an urgent need for educational and psychological adjustment to stimulate the patient's motivation to actively carry out rehabilitation, so as to reduce negative emotions, enhance the patient's intrinsic motivation for rehabilitation, and reduce the patient's disability. Studies have shown that interventions based on character strengths are widely used in chronic disease patients abroad, and have achieved the effect of improving the physical and mental health of patients. However, research on individualized character strengths in stroke patient intervention is limited, and more clinical evidence is needed. This study is based on personality theory and the application of character strengths-based STEP programme (CSSTEP) in stroke patients. The investigators hypothesized that the CSSTEP programme could help stroke patients to improve mental state, cognitive function, and better gait performance, suffer from less post-stroke depression, enhance their post-stroke self-confidence. In addition, the investigators will use the application of CSSTEP in stroke care to provide a theoretical basis for a new personality direction for clinical psychological intervention, and provide new ideas and ideas for improving the stroke rehabilitation system and establishing a new personalized post-stroke intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •① Clinical diagnosis of stroke, CT or MRI diagnosis of cerebral infarction;
- •② Within 30 days after clinical diagnosis of acute stroke;
- •③ Age ≥18 years;
- •④ Basic cognition, learning ability and willingness, all vital signs were stable, no other serious complications and no history of mental illness;
- •⑤ Informed consent and cooperation.
排除标准
- •① Moderate or severe cognitive impairment (defined as mini-mental state examination score ≤20);
- •② Unstable vital signs, accompanied by severe heart, liver, renal insufficiency, respiratory failure and malignant tumors, unable to intervene.
结局指标
主要结局
Change from Baseline Depression at 1 month. Hamilton Depression Scale (HAMD-24) Scale
时间窗: Baseline, Post-intervention within one week, One month after intervention
This outcome will be measured by a specific scale/questionnaire, which is Hamilton Depression Scale (HAMD-24) Scale. Scores range from 0-52, higher scores mean worse outcome.
次要结局
- Change from Baseline Neurological function at 1 month. National Institutes of Health Stroke Scale (NIHSS) Scale(Baseline, Post-intervention within one week, One month after intervention)
- Change from Baseline Cognitive function at 1 month. Mini-mental State Examination (MMSE) Scale(Baseline, Post-intervention within one week, One month after intervention)
- Change from Baseline Gait speed at 1 month(Baseline, Post-intervention within one week, One month after intervention)
- Change from Baseline Self-esteem at 1 month. Rosenberg Self-esteem Scale (RSES) Scale(Baseline, Post-intervention within one week, One month after intervention)
研究者
YAN Tingting, PhD
Principal Investigator
Peking University