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Behavioural Intervention

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 (tACS/CBTpSZ Trial)

Kingston, Canada

N/A

Waitlist Available

Led By Felicia Iftene, Associate Professor, Md, PhD

Research Sponsored by Felicia Iftene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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);

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the q-les-q-sf will be performed at: visit 2, baseline (week 1); visit 3 mid-way intervention (week 9), visit 4 end of intervention (week 17); visit 5 follow-up 1 (week 21); visit 6 follow-up 2 (week 2.9)

Awards & highlights

No Placebo-Only Group

Summary

We 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, we aim to understand if addressing the oscillation perturbations could reduce the cognitive deficits. We are using heart rate variability (HRV) as a biomarker of improvement of somatic and mental health. We 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, we 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. We expect 150 potentially eligible patients from PCH-MHS, with 28 participants consenting to participate.

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Who is the study for?

This trial is for individuals with schizophrenia or at high risk for psychosis. Participants must meet DSM V criteria for schizophrenia and can be stratified by age and sex. They should not have comorbid metabolic conditions, substance use issues, abnormal lab work (like blood sugar or cholesterol levels), or a body mass index outside the set range.Check my eligibility

What is being tested?

The study tests if transcranial alternating current stimulation (tACS) before cognitive behavioral therapy for psychosis (CBTp) improves treatment outcomes in schizophrenia when added to usual medication. It's a single-blind study with two groups: one receiving real tACS/CBTp and another getting sham tACS but real CBTp over 16 weeks, plus follow-ups.See study design

What are the potential side effects?

Potential side effects may include discomfort from the electric stimulation during tACS sessions, possible skin irritation where electrodes are placed, headaches, dizziness, or other unspecified reactions related to the non-invasive brain stimulation procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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3. all genders between ages 18-65 (participants 65+ may be eligible depending on performance on cognitive assessment);

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4. ability to understand English with reading level at or above grade 6;

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5. able to understand and comply with the requirements of the study;

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6. provision of written informed consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CFS (Cognitive Flexibility Scale)

NSA-16 (Negative Symptom Assessment)

PANSS (Positive and Negative Symptoms of Schizophrenia Scale)

Secondary study objectives

Brief Betrayal Trauma Survey (BBTS)

Electroencephalogram (EEG)

Heart Rate Variability (HRV)

+7 more

Other study objectives

Eligibility Screening Measures: Columbia Suicide Severity Rating Scale

Eligibility Screening Measures: The Montreal Cognition Assessment (MoCA), for participants over age of 65.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: tACS/CBTp, both active/ interventionExperimental Treatment1 Intervention

n=14; participants living with schizophrenia/schizoaffective disorder, stable under their usual medication; tACS (gamma band electric stimulation) will be applied the first 20 minutes of the CBTp session (then the device remains in place, but the electric stimulation will be automatically stopped). The CBTp will continue up until a total of 50 minutes/session.

Group II: Sham tACS and CBTp (only CBTp active, intervention)Placebo Group1 Intervention

n=14, same diagnosis population, gender and age matched; sham tACS, CBTp for 50 minutes/session.

0 / 6Eligibility criteria met