NCT07747181招募中不适用
Yoga and tDCS to Improve Cognitive Function in Individuals With Psychosis: A Pragmatic Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Verbal Fluency Test
研究概览
简要总结
The study examines (1) the effects of active anodal (facilitatory) tDCS and yoga combined intervention on cognitive function, clinical symptoms, and quality of life domains (social function and physical wellbeing) in psychosis, and (2) the neurophysiological mechanisms underlying the effects induced by the combined intervention.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) aged 18 to 65 years
- •(2) diagnosis based on SCID for schizophrenia and related disorders, psychosis, and delusional disorder with the positive symptom measured by CGI ≤ 3
- •(3) ability to understand the nature of the study and to give informed consent (The MacArthur Competence Assessment Tool for Clinical Research score ≥ 35)
- •(4) Chinese-speaking
- •(5) fewer than 10 hours of yoga and other mind-body intervention (e.g., Tai Chi, Qigong, Mindfulness) in the previous 3 months.
排除标准
- •(1) Severe physical diseases, such as myocardial infarction, uncontrollable severe hypertension, fracture, severe spinal problems, or contraindication for exercise
- •(2) comorbid substance dependence and seizure disorders
- •(3) pregnancy or other contraindication to fNIRS
- •(4) known history of intellectual disability or special school attendance, brain trauma, or organic brain disease
- •(5) Individuals taking Benzodiazepine will still be recruited in the project, and will be excluded from the fNIRS measure.
研究组 & 干预措施
Active tDCS and yoga
Active Comparator
干预措施: Yoga (Behavioral)
Active tDCS and yoga
Active Comparator
干预措施: Active tDCS (Device)
Sham tDCS and yoga
Sham Comparator
干预措施: Sham tDCS (Device)
Sham tDCS and yoga
Sham Comparator
干预措施: Yoga (Behavioral)
Waitlist control group
No Intervention
结局指标
主要结局
Verbal Fluency Test
时间窗: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
A measure of executive function. Participants have to name as many animals as possible in 60 seconds. Higher scores indicate better executive functioning.
次要结局
- Logical Memory test(Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2))
- Digit Span Test(Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2))
- Positive and Negative Syndrome Scale (PANSS)(Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2))
- Calgary Depression Scale(Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2))
- Social and Occupational Functioning Assessment Scale (SOFAS)(Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2))
- Role Functioning Scale (RFS)(Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2))
- The Short Form Health Survey (SF-36)(Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2))
- BMI(Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2))
- Sit-and-Reach Test(Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2))
- Standing Balance Test(Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2))
- Digit Symbol Coding Test(Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2))
- Letter Cancellation Test(After the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2))
- Trail Making Test (TMT)(After the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2))
- Changes of HbO and HbR in prefrontal regions during resting and cognitive task measured by fNIRS(Baseline (T0), and after the 6-week interventions/waiting (T1))
- Correlation of changes in HbO and HbR among prefrontal regions (connectivity)(Baseline (T0), and after the 6-week interventions/waiting (T1))
- Attendance of the interventions(After the 6-week interventions/waiting (T1))
- Home-based practice frequency and duration checklist(After the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2))
研究者
LIN Jingxia Jessie
Assistant Professor
The Hong Kong Polytechnic University
研究点 (1)
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