The Effect of Combined Brain Stimulation and Yoga for Improving Cognitive Function in Psychosis
4 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
135
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Kowloon
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Hung Hom, Kowloon, Hong Kong
- Reclutamiento
- The Hong Kong Polytechnic University
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Contacto:
- Prof. Jessie LIN
- Número de teléfono: +85227666718
- Correo electrónico: jx-jessie.lin@polyu.edu.hk
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Grupo de control de lista de espera
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Comparador activo: 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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Comparador falso: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Verbal Fluency Test
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Logical Memory test
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
30 de junio de 2028
Fechas de registro del estudio
Enviado por primera vez
30 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de agosto de 2026
Publicado por primera vez (Actual)
5 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 25124024
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .