Therapeutic Improvement in People With Schizophrenia Undergoing tACS/CBTp (Transcranial Alternating Current Stimulation Applied Pre-cognitive Behavioral Therapy for Psychosis) Associated to Usual Medication Regimen
Experimental: tASC/CBTp: gamma band electric stimulation for 20 minutes at the beginning of the CBTp sessionSham Comparator
Experimental: tASC/CBTp: gamma band electric stimulation for 20 minutes at the beginning of the CBTp session: For the transcranial stimulation we will use the tES device from NeuroMyst,. The gamma pulses are delivered to a study participant via stimulating electrodes positioned at participant's head according to the required technique. The tACS will be applied the first 20 minutes from the classic CBTp session for the experimental group.
Sham Comparator: For the Sham group the investigators will use the same tES device from NeuroMyst. The Sham stimulation will be applied only for a few seconds in Sham group. The CBTp will follow the same protocol for both arms.
Study summary
The investigators are proposing a new, non-invasive therapeutic model using transcranial alternative current stimulation (tACS), to augment cognitive behavioral therapy for psychosis (CBTp) efficacy in individuals with schizophrenia (SZ). Using EEG brain oscillation activity, as a biomarker of the progression of cognitive deficits in SZ, the investigators aim to understand if addressing the oscillation perturbations could reduce the cognitive deficits. The investigators are using heart rate variability (HRV) as a biomarker of improvement of somatic and mental health. The investigators are aiming also for an analysis through a GBA+ lens, by using along with specific tests for psychosis (PANSS, NSA-16, etc.), the BEM Sex Role Inventory. Considering that cognitive and emotional status is gender dependent, the investigators expect that the therapeutic response could be gender specific. This is a prospective, randomized, repeated-measures, single-blind study design. Pre-intervention, eligible participants will be randomly assigned to one of two treatment arms. Arm 1 (tACS/CBTp n=14); Arm 2 (sham tACS/CBTp, n=14; tACS is sham, but CBTp is active). Intervention (16 weeks): participants in Arms 1 and 2 will receive once weekly tACS/ CBTp or sham tACS/CBTp. Post-intervention: follow-up visits at 4- and 12-weeks post-intervention (with a tACS/CBTp booster session provided each time). The chart review will search for: comorbid metabolic conditions, lab work abnormalities (glycemic level, Hb A, cholesterol), substances use, BMI, type of medication, side effects. Expected outcomes: Participants in Arm 1 will show a better improvement in psychosocial assessment scores, electrical brain activity (tendency to organize the neural oscillations in the gamma frequency range, mainly in frontal lobes) and heart activity (increased HRV). The timeline for recruitment, treatment and follow-up, is 18 months, followed by six months for data analysis, dissemination activities. Population: Individuals with SZ (DSM V criteria) stratified by age and sex. The investigators expect 150 potentially eligible patients from PCH-MHS, with 28 participants consenting to participate.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Individuals, with at least 5 years duration of illness, that meet diagnostic criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual for Mental Disorders-5 and at least one residual positive symptom (as determined by the referring physician);
2. no change in medication regimen for at least 1 months (minor dose adjustments and/or change in medication involving symptoms as sleep, anxiety or medical symptoms such as fever, pain, are permitted);
3. all genders between ages 18-65 (participants 65+ may be eligible depending on performance on cognitive assessment);
4. ability to understand English with reading level at or above grade 6;
5. able to understand and comply with the requirements of the study;
6. provision of written informed consent.
Exclusion Criteria:
1. current illicit drug substance abuse;
2. current suicidal ideation;
3. current enrollment in CBTp or other formalized psychosocial interventions;
4. undergone vagotomy or surgery upon the vagus nerve;
5. comorbid neurological condition;
6. severe or moderate intellectual disability;
7. currently undergoing hormone therapy;
8. under age 18.
NOTE: changes in medication/new hospitalization for worsening symptoms and/or presence of suicidal ideation are no more exclusion criteria for subjects that have passed visit 5 (end of intervention, during follow-ups stage); however the results of the follow-up visits will count at the final results, depending on the severity/imminent danger of symptoms and medication changes, at the best judgment of the principal investigator
Primary outcome measure(s)
PANSS (Positive and Negative Symptoms of Schizophrenia Scale) — Positive and Negative Symptoms of Schizophrenia scale will be applied at: Visit 1, Screening (Week 0); Visit 4, End of intervention (Week 17); Visit 5,Follow-up 1 (Week 21); Visit 6 Follow-up 2 (Week 29). The PANSS is a standardized clinical interview that rates the presence and severity of positive and negative symptoms and general psychopathology for people with schizophrenia within the past week. The scale consists of 30 items: seven positive, seven negative, and 16 general psychopathology symptoms. The symptom severity for each item is rated according to a 7-point scale (1 = absent; 7 = extreme) to best describe the symptom's presentation. The clinical interview takes approximately 45 minutes. The patient is rated from 1 to 7 on 30 different symptoms based on the discussion and reports of family members or primary care hospital workers. As 1 is the lowest score for each item, a patient can not score lower than 30 for the total PANSS score. Scores are often given separately for positive items, negative items, and general psychopathology.
NSA-16 (Negative Symptom Assessment) — Negative Symptom Assessment-16: Visit 2, Baseline (Week 1); Visit 4, End of intervention (Week 17); Visit 5, Follow-up 1 (Week 21); Visit 6 Follow-up 2 (Week 29). The NSA-16 assesses the presence, severity, and range of negative symptoms associated with schizophrenia. For rapid clinical assessment or screening of patients for negative symptoms, the NSA-4 was developed as a simplified version, retaining only 4 of the 16 items: restricted speech quantity, reduced emotion, reduced social drive, and reduced interests. Each of the four items and the overall global negative symptoms is rated on a 1 to 6-point scale where '1' represents no reduction from normal behaviors associated with the item and '6' represents a severe reduction in or absence of the behavior, with markedly impaired functionality. With respect to overall accuracy and predictive validity, the NSA-4 is comparable to the NSA-16.
CFS (Cognitive Flexibility Scale) — Cognitive Flexibility Scale: Visit 2, Baseline (Week1 ); Visit 3 Mid point of intervention (Week 9); Visit 4, End of intervention (Week 17); Visit 5, Follow-up 1 (Week 21); Visit 6, Follow-up 2 (Week 29). The CFS assesses cognitive flexibility as a factor that facilitates the individual's adaptability towards events. Cognitive flexibility refers to a person's awareness that different communication styles exist in every situation and the person's willingness and self-efficacy to use different communicative styles. The scale has 12 items pertaining to the three elements of cognitive flexibility: a person's awareness of alternative communicative styles, willingness to be communicatively flexible, and self-efficacy in being communicatively flexible. The scale utilizes a 6-point Likert-type scale for each item (with 6 as "strongly agree," 5 as "agree," 4 as "slightly agree," 3 as "slightly disagree," 2 as "disagree," and 1 as "strongly disagree"). The total score was used to calculate a global score ranging from 12 to 72, with questions 2, 9, 11, and 12 being reverse-coded. A higher score indicates higher cognitive flexibility.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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