The Effect of Combined Brain Stimulation and Yoga for Improving Cognitive Function in Psychosis
Yoga and tDCS to Improve Cognitive Function in Individuals With Psychosis: A Pragmatic Controlled Trial
1 other identifier
interventional
135
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2026
CompletedFirst Submitted
Initial submission to the registry
July 30, 2026
CompletedFirst Posted
Study publicly available on registry
August 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
August 5, 2026
August 1, 2026
2 years
July 30, 2026
August 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Verbal Fluency Test
A measure of executive function. Participants have to name as many animals as possible in 60 seconds. Higher scores indicate better executive functioning.
Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)
Secondary Outcomes (17)
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)
- +12 more secondary outcomes
Study Arms (3)
Active tDCS and yoga
ACTIVE COMPARATORSham tDCS and yoga
SHAM COMPARATORWaitlist control group
NO INTERVENTIONInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hong Kong Polytechnic University
Hung Hom, Kowloon, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 30, 2026
First Posted
August 5, 2026
Study Start
January 1, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
August 5, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share