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Recruiting NCT07747181

The Effect of Combined Brain Stimulation and Yoga for Improving Cognitive Function in Psychosis

No phase Interventional Cognitive Functioning Psychosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active tDCS, Sham tDCS, Yoga.
Who it may be relevant to
Registry conditions: Cognitive Functioning, Psychosis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Yoga and tDCS to Improve Cognitive Function in Individuals With Psychosis: A Pragmatic Controlled Trial

Overview

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.

Interventions

  • Device Active tDCS
    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.
  • Device Sham tDCS
    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.
  • Behavioral Yoga
    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 se

Primary outcome measures

  • Verbal Fluency Test [Time frame: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
Secondary outcome measures (12)
  • Logical Memory test [Time frame: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • Digit Span Test [Time frame: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • Positive and Negative Syndrome Scale (PANSS) [Time frame: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • Calgary Depression Scale [Time frame: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • Social and Occupational Functioning Assessment Scale (SOFAS) [Time frame: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • Role Functioning Scale (RFS) [Time frame: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • The Short Form Health Survey (SF-36) [Time frame: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • BMI [Time frame: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • Sit-and-Reach Test [Time frame: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • Standing Balance Test [Time frame: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • Digit Symbol Coding Test [Time frame: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • Letter Cancellation Test [Time frame: After the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Hong Kong Polytechnic University — Hung Hom

Identifiers

NCT: NCT07747181 · 25124024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗