Effectiveness of Mindfulness-based Cognitive Therapy Undergoing Post-stroke Rehabilitation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Change from 6 weeks on Beck Depression Inventory (BDI) at 3 months
研究概览
简要总结
The goal of this clinical trial is to investigate the efficacy of mindfulness-based cognitive therapy compared to usual care for stroke survivors undergoing inpatient rehabilitation.
详细描述
It was hypothesized that group-based MBCT would lead to improving mood, mindfulness, social support, physical, and neurocognitive function; and that these improvements would be maintained over the 3-month follow-up period. Participants in the control group received only usual care, the intervention group were involved in MBCT intervention in addition to usual care. MBCT intervention was designed to consist of eight 1.5-hour group sessions over 6 consecutive weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stroke patients with functional impairments
- •confirmation of stroke by CT or MRI scan
- •age between 18-90 years
- •had adequate communication skills, cognitive and physical capacity to participate in study activities
- •competence to provide informed consent
排除标准
- •severe cognitive impairment according to the Word List Learning Instrument (total score <7)
- •severe depression according to the Beck Depression Inventory (BDI) (total score>25)
- •history of severe mental illness (psychotic disorder, schizophrenia, severe depression, bipolar disorder, PTSD, suicidal tendencies)
- •the current change in the antidepressant therapy.
结局指标
主要结局
Change from 6 weeks on Beck Depression Inventory (BDI) at 3 months
时间窗: 6 weeks and 3 months
Beck Depression Inventory (BDI) was used to assess severity of the depression with 21 items scored from 0 to 3 (hiv, Beck, 1961). Scores range from 0 to 63 with 0-9 representing normal value, 10-18 mild, 19-25 moderate, and ≥ 26 severe depression.
Change from baseline on Beck Depression Inventory (BDI) at 6 weeks
时间窗: Baseline and 6 weeks
Beck Depression Inventory (BDI) was used to assess severity of the depression with 21 items scored from 0 to 3 (hiv, Beck, 1961). Scores range from 0 to 63 with 0-9 representing normal value, 10-18 mild, 19-25 moderate, and ≥ 26 severe depression.
Change from baseline on The Spielberger State-Trait Anxiety Inventory (STAI-X) at 6 weeks
时间窗: Baseline and 6 weeks
The Spielberger State-Trait Anxiety Inventory (STAI-X) was used to assess anxiety both as a state and trait. State anxiety was measured by STAI form X-1, requiring participants to answer questions about how they feel right now. Trait anxiety was measured by the STAI form X-2, requiring participants to answer questions about how they feel generally. Both scales (X-1, X-2) consist of 20 items scored from 1 to 4. Scores range from 20 to 80 with higher scores representing higher state or trait anxiety.
Change from 6 weeks on The Spielberger State-Trait Anxiety Inventory (STAI-X) at 3 months
时间窗: 6 weeks and 3 months
The Spielberger State-Trait Anxiety Inventory (STAI-X) was used to assess anxiety both as a state and trait. State anxiety was measured by STAI form X-1, requiring participants to answer questions about how they feel right now. Trait anxiety was measured by the STAI form X-2, requiring participants to answer questions about how they feel generally. Both scales (X-1, X-2) consist of 20 items scored from 1 to 4. Scores range from 20 to 80 with higher scores representing higher state or trait anxiety.
次要结局
- Change from baseline on The Five Facet Mindfulness Questionnaire (FFMQ) at 6 weeks(Baseline and 6 weeks)
- Change from 6 weeks on The Five Facet Mindfulness Questionnaire (FFMQ) at 3 months(6 weeks and 3 months)
- Change from baseline on The Multidimensional Scale of Perceived Social Support Scale(MSPSS) at 6 weeks(Baseline and 6 weeks)
- Change from 6 weeks on The Multidimensional Scale of Perceived Social Support Scale (MSPSS) at 3 months(6 weeks and 3 months)
- Change from baseline on Touluose-Piéron test(TP) at 6 weeks(Baseline and 6 weeks)
- Change from 6 weeks on Touluose-Piéron test(TP) at 3 months(6 weeks and 3 months)
- Change from 6 weeks on Fugl-Meyer Assessment (FMA) at 3 months(6 weeks and 3 months)
- Change from 6 weeks on Functional Independence Measure (FIM) at 3 months(6 weeks and 3 months)
- Change from baseline on Fugl-Meyer Assessment (FMA) at 6 weeks(Baseline and 6 weeks)
- Change from baseline on Functional Independence Measure (FIM) at 6 weeks(Baseline and 6 weeks)