The Effect of Combined Brain Stimulation and Yoga for Improving Cognitive Function in Psychosis
2026年8月4日 更新者：LIN Jingxia Jessie、The Hong Kong Polytechnic University
Yoga and tDCS to Improve Cognitive Function in Individuals With Psychosis: A Pragmatic Controlled Trial
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.
調査の概要
状態
状態
募集
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
介入
入学 (推定)
入学
135
段階
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Kowloon
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Hung Hom、Kowloon、香港
- 募集
- The Hong Kong Polytechnic University
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コンタクト：
- Prof. Jessie LIN
- 電話番号：+85227666718
- メール：jx-jessie.lin@polyu.edu.hk
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- (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.
Exclusion Criteria:
- (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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
アーム数
3
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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介入なし：待機リスト コントロール グループ
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アクティブコンパレータ：Active tDCS and yoga
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Active tDCS will be applied using a wearable stimulator (LifTid) with a constant stimulation intensity of 1.2 mA for 20 minutes.
The device has been designed for anodal stimulation targeting DLPFC using the F3 (anode) to F4 (cathode) montage.
Yoga will be based on the basic theory and research of the foundation of Hatha yoga.
Participants will cultivate the learning of yoga through various kinds of activity, such as breathing control, body postures, and relaxation.
The yoga is designed to create an overall effect on the body and mind through strength training and stretching with a mindful sensation.
Each 1-hour intervention session contains reviewing the last week self-practice, breathing practice and warm-up (10 minutes), posture sequences (40 minutes), relaxation (5 minutes), reflection and feedback (5 minutes).
Video clips will be provided through social media apps (i.e., WhatsApp, WeChat) to enable home-based practice at least twice weekly.
A logbook will be distributed to the participants for their record of self-practice and will be reviewed weekly by the intervention facilitator.
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偽コンパレータ：Sham tDCS and yoga
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Yoga will be based on the basic theory and research of the foundation of Hatha yoga.
Participants will cultivate the learning of yoga through various kinds of activity, such as breathing control, body postures, and relaxation.
The yoga is designed to create an overall effect on the body and mind through strength training and stretching with a mindful sensation.
Each 1-hour intervention session contains reviewing the last week self-practice, breathing practice and warm-up (10 minutes), posture sequences (40 minutes), relaxation (5 minutes), reflection and feedback (5 minutes).
Video clips will be provided through social media apps (i.e., WhatsApp, WeChat) to enable home-based practice at least twice weekly.
A logbook will be distributed to the participants for their record of self-practice and will be reviewed weekly by the intervention facilitator.
Sham tDCS will be performed using the same device but without stimulation.
During the yoga training, all participants will wear the device and a facilitator will turn on the stimulation for participants receiving a-tDCS-Y intervention, and pretend to turn on the stimulation for participants receiving s-tDCS-Y intervention after the first 10-minute section.
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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Verbal Fluency Test
時間枠：Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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A measure of executive function.
Participants have to name as many animals as possible in 60 seconds.
Higher scores indicate better executive functioning.
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Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Logical Memory test
時間枠：Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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The Logical Memory test is a standardized test used to evaluate narrative verbal memory, immediate free recall, and delayed free recall.
The examiner reads one short, structured stories aloud to the participant.
The test consists of two main parts: Logical Memory I (Immediate Recall), where the participant is asked to retell the story from memory immediately after hearing it, and Logical Memory II (Delayed Recall), where the participant is asked to retell the story again after a 30-minute delay.
Scoring is based on the total number of predefined story elements or ideas correctly recalled.
For each story, the raw score ranges from 0 to 23 story units.
Higher scores indicate better verbal memory and auditory narrative recall capabilities.
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Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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Digit Span Test
時間枠：Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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The Digit Span Test is a standardized cognitive subtest used to evaluate short-term verbal memory, attention, and working memory.
The examiner reads a sequence of random numbers aloud at a rate of one digit per second, and the participant is asked to repeat them.
The test consists of two primary components: Digit Span Forward (where digits are repeated in the exact order heard to assess attention and short-term memory) and Digit Span Backward (where digits are repeated in the reverse order to assess working memory and mental manipulation).
Scoring is based on the total number of trials correctly recalled.
Higher scores indicate better auditory attention, short-term memory capacity, and working memory functioning.
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Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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Positive and Negative Syndrome Scale (PANSS)
時間枠：Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale used to measure the symptom severity of patients with schizophrenia.
It consists of three subscales: the Positive Scale (7 items), the Negative Scale (7 items), and the General Psychopathology Scale (16 items).
Each item is rated on a 7-point symptom-severity scale from 1 (absent) to 7 (extreme).
The total score ranges from a minimum of 30 to a maximum of 210.
Higher scores indicate greater severity of psychiatric symptoms.
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Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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Calgary Depression Scale
時間枠：Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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The Calgary Depression Scale is a 9-item structured interview scale specifically designed to assess the severity of depression in patients with schizophrenia.
Each of the 9 items is scored on a 4-point scale from 0 (absent) to 3 (severe).
The total score ranges from a minimum of 0 to a maximum of 27.
Higher scores indicate more severe depressive symptoms.
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Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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Social and Occupational Functioning Assessment Scale (SOFAS)
時間枠：Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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The Social and Occupational Functioning Assessment Scale (SOFAS) is a clinician-rated numeric scale used to assess an individual's level of social and occupational functioning, distinct from the severity of their psychological or psychiatric symptoms.
The scale ratings range from 1 to 100, divided into 10-point intervals.
A score of 100 represents superior functioning in a wide range of activities, while a score of 1 indicates a persistent inability to maintain minimal personal hygiene or gross impairment in social and occupational functioning.
Higher scores indicate a higher level of social and occupational functioning and greater independence.
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Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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Role Functioning Scale (RFS)
時間枠：Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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The Role Functioning Scale (RFS) is a 4-item instrument designed to assess the level of functioning of individuals with severe mental illness in four areas: Working Productivity, Immediate Past Social Network, Extended Social Network, and Independent Living / Self-Care.
Each of the 4 domains is rated on a 7-point behavioral index scale ranging from 1 (severely impaired) to 7 (optimal functioning).
The total score ranges from a minimum of 4 to a maximum of 28.
Higher scores indicate a higher level of role functioning and greater independence.
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Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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The Short Form Health Survey (SF-36)
時間枠：Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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The 36-Item Short Form Health Survey (SF-36) is a patient-reported questionnaire used to assess health-related quality of life.
It measures eight health domains: Physical Functioning, Role Limitations due to Physical Health, Role Limitations due to Emotional Problems, Energy/Fatigue, Emotional Well-Being, Social Functioning, Pain, and General Health.
Responses are multi-choice, and individual domain scores are transformed onto a scale from 0 to 100.
For each domain and summary score, the scale range is 0 to 100, where higher scores indicate better health status and higher quality of life.
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Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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BMI
時間枠：Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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Body Mass Index (BMI) is a standardized anthropometric measure used to estimate body fat and classify weight status.
It is calculated by dividing an individual's body weight in kilograms by the square of their height in meters (kg/m²).
Higher BMI values indicate greater body mass relative to height, which can correspond to higher body fat levels.
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Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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Sit-and-Reach Test
時間枠：Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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A common measure of flexibility, specifically assessing the lower back and hamstring muscles.
The subject is seated against the wall, arms outstretched towards the box.
A sliding ruler is used to measure the position of the fingertips.
Higher scores (greater distance reached) indicate greater hamstring and lower back flexibility.
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Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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Standing Balance Test
時間枠：Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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Give the subject a minute to practice their balancing before starting the test.
Then ask the person to stand on one foot for as long as possible.
The total length of time a person can stay in the balance position will be recorded.
The timing stops when the elevated foot touches the ground or the person hops or otherwise loses their balance position.
The test will be conducted with the person having their arms on their waist.
Repeat the test on the other leg.
Higher scores (longer durations) indicate better static balance and postural control.
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Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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Digit Symbol Coding Test
時間枠：Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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The Digit Symbol Coding Test is a standardized paper-and-pencil neurocognitive task used to assess processing speed, attention, psychomotor performance, and visual-motor coordination.
Participants are presented with a key pairing single digits (1 through 9) with unique geometric symbols.
Below the key, rows of digits are displayed with empty spaces beneath them.
Participants are instructed to write the correct corresponding symbol for each digit as quickly and accurately as possible within 120 seconds.
The outcome score is calculated as the total number of correct digit-symbol pairs completed within the time frame.
Higher scores indicate superior processing speed and enhanced cognitive efficiency.
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Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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Letter Cancellation Test
時間枠：After the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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The Letter Cancellation Test is a standardized paper-and-pencil psychomotor task used to assess visual attention, sustained attention, psychomotor speed, and visual neglect.
Participants are presented with a sheet of paper containing rows of random letters and are instructed to cross out (cancel) a specific target letters as quickly and accurately as possible.
The outcome score is reported as the total number of correct targets identified (hits).
Higher scores indicate superior visual attention and faster processing speed.
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After the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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Trail Making Test (TMT)
時間枠：After the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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The Trail Making Test (TMT) is a standard neurocognitive task used to assess visual search, scanning, processing speed, and executive function.
It consists of two distinct parts: Part A and Part B. In Part A (TMT-A), participants are instructed to connect a series of encircled numbers in chronological order (1-2-3, etc.) as quickly and accurately as possible.
In Part B (TMT-B), participants must connect a alternating series of encircled numbers and letters in sequential order (1-A-2-B-3-C, etc.).
The outcome score for each part is recorded as the total time in seconds required to complete the trail.
Lower scores (shorter durations to complete the task) indicate superior processing speed, enhanced cognitive flexibility, and better executive functioning.
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After the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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Changes of HbO and HbR in prefrontal regions during resting and cognitive task measured by fNIRS
時間枠：Baseline (T0), and after the 6-week interventions/waiting (T1)
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Functional Near-Infrared Spectroscopy (fNIRS) is a non-invasive optical imaging technique used to monitor hemodynamic responses in the cerebral cortex.
This outcome measure evaluates the relative concentration changes of oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) within defined regions of interest in the prefrontal cortex (PFC).
Measurements are continuously recorded during two distinct states: a resting-state baseline condition and a target cognitive task condition.
Increased HbO concentration accompanied by a concurrent decrease in HbR concentration relative to baseline indicates localized cortical activation in the prefrontal region during the cognitive task.
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Baseline (T0), and after the 6-week interventions/waiting (T1)
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Correlation of changes in HbO and HbR among prefrontal regions (connectivity)
時間枠：Baseline (T0), and after the 6-week interventions/waiting (T1)
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Functional connectivity within the prefrontal cortex (PFC) is evaluated by measuring the temporal correlation of hemodynamic signal fluctuations.
Continuous fNIRS data for both oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) are recorded during resting-state and the cognitive task.
After preprocessing to remove systemic noise and motion artifacts, the functional connectivity is quantified by calculating the Pearson correlation coefficient (r) and its Fisher z-transformed equivalent between the time courses of different prefrontal regions.
The resulting correlation values range from -1.0 to +1.0 .
Higher positive values indicate stronger functional connectivity and greater synchronized neural activity between those specific prefrontal cortical regions.
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Baseline (T0), and after the 6-week interventions/waiting (T1)
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Attendance of the interventions
時間枠：After the 6-week interventions/waiting (T1)
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Number of class attended during the 6-week intervention.
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After the 6-week interventions/waiting (T1)
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Home-based practice frequency and duration checklist
時間枠：After the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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Participants report the frequency and duration of doing the home-based practice.
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After the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
研究開始
2026年1月1日
一次修了 (推定)
一次修了
2027年12月31日
研究の完了 (推定)
研究の完了
2028年6月30日
試験登録日
最初に提出
最初に提出
2026年7月30日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年8月4日
最初の投稿 (実際)
最初の投稿
2026年8月5日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年8月5日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年8月4日
最終確認日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 25124024
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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