The Effect of Combined Brain Stimulation and Yoga for Improving Cognitive Function in Psychosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Hong Kong Polytechnic University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(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
Disqualifiers
(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
Trial design
Design model
Parallel
Treatments tested in this trial
Active tDCS
DeviceActive 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
DeviceSham 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
BehavioralYoga 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.
Treatment groups
135 Participants
are divided into 3 treatment groupsGroup A: Active tDCS and yogaActive comparator 2 interventions
Group B: Sham tDCS and yogaSham comparator 2 interventions
Group C: Waitlist control groupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)Secondary outcomes
1
Logical Memory test
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.
Time frame
Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)2
Digit Span Test
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.
Time frame
Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)3
Positive and Negative Syndrome Scale (PANSS)
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.
Time frame
Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)4
Calgary Depression Scale
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.
Time frame
Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)Sponsors and contacts
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Source ClinicalTrials.gov