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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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);
• 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);
• all genders between ages 18-65 (participants 65+ may be eligible depending on performance on cognitive assessment);
• ability to understand English with reading level at or above grade 6;
• able to understand and comply with the requirements of the study;
• provision of written informed consent.

🚫 You may not be able to join if…

• current illicit drug substance abuse;
• current suicidal ideation;
• current enrollment in CBTp or other formalized psychosocial interventions;
• undergone vagotomy or surgery upon the vagus nerve;
• comorbid neurological condition;
• severe or moderate intellectual disability;
• currently undergoing hormone therapy;
• 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

Where this trial is running

• Providence Care Hospital, Kingston, Ontario, Canada

Who to contact

Felicia Iftene, MD, PhD, FRCPC; Associate Prof · 613-484-7330 · iftenef@providencecare.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06889025.