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

Launched by FELICIA IFTENE · Mar 15, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for people with schizophrenia or schizoaffective disorder. The study combines a technique called transcranial alternating current stimulation (tACS) with cognitive behavioral therapy for psychosis (CBTp) to see if it can improve thinking and emotional well-being. Researchers will be looking at brain activity and heart health to assess how well this treatment works. A total of 28 participants will be involved, and they will be randomly assigned to either receive the active treatment or a placebo (sham tACS) for 16 weeks, followed by follow-up visits to check on their progress.

To be eligible for this trial, participants should be between 18 and 65 years old, have had schizophrenia or schizoaffective disorder for at least five years, and be stable on their current medication for at least one month. They also need to be able to read and understand English. Participants can expect to attend weekly sessions for treatment and follow-ups after the study ends. It's important to note that this study has not started recruiting participants yet, but it aims to help improve the lives of those living with these mental health conditions through innovative therapies.

Gender

ALL

Eligibility criteria

• 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