NCT06936397

Cognitive Remediation Therapy for Schizophrenia: Effects on EEG and Emotional Regulation

A Randomized Controlled EEG-GSR Study on the Effects of Cognitive Remediation Therapy on Neurophysiological and Emotional Regulation Markers in Schizophrenia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Beykoz University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study aims to determine whether Cognitive Remediation Therapy (CRT) can improve attention, memory, and emotional regulation in people with schizophrenia. CRT is a structured program that includes exercises to strengthen cognitive skills such as problem-solving, working memory, and emotion regulation. The study will recruit 60 participants: 30 individuals with schizophrenia and 30 healthy individuals of similar age and gender. Those with schizophrenia will be randomly assigned to either receive CRT or be placed on a waitlist without therapy. All participants will undergo non-invasive brain activity (EEG) and emotional response (GSR) recordings before and after the therapy. The study's main question is: Does participating in a 12-week CRT program improve brain-based markers of attention and emotional regulation in people with schizophrenia? Additional tests, such as memory and emotion recognition tasks and self-report questionnaires, will help assess changes in thinking skills and emotional well-being. The study may help better understand how CRT affects both brain function and quality of life in schizophrenia.

Detailed description

This is a randomized controlled trial examining the effects of Cognitive Remediation Therapy (CRT) on neurophysiological and behavioral outcomes in schizophrenia. The primary goal is to assess whether CRT improves attentional control, sensory processing, executive function, and emotional regulation as measured by EEG and GSR. Sixty participants will be enrolled: 30 individuals diagnosed with schizophrenia (DSM-5 criteria) and 30 healthy controls matched by age and gender. The schizophrenia group will be randomized into a CRT intervention arm and a waitlist control group. Healthy controls will not undergo CRT but will participate in baseline neurophysiological assessments to establish normative EEG and GSR values. CRT will consist of 12 weekly sessions (approximately 60 minutes each), targeting cognitive domains such as working memory, attention, executive function, and emotion regulation using structured exercises and computer-based tasks. EEG recordings will include P300 (oddball paradigm), mismatch negativity (MMN), and frontal theta power (cognitive control tasks). GSR will assess baseline skin conductance and reactivity to negative emotional stimuli. Behavioral tasks include the Stroop task, digit span, and facial emotion recognition. Psychometric instruments include the Turkish-validated versions of: * Difficulties in Emotion Regulation Scale (DERS) * Brief Assessment of Cognition in Schizophrenia (BACS) * Schizophrenia Quality of Life Scale (SQLS) Primary outcomes will be assessed via pre- and post-test comparisons. Statistical methods include repeated-measures ANOVA, mixed-effects modeling, and regression analyses linking physiological changes to cognitive and emotional performance. The study is ethically approved and aligns with international standards for human research.

Conditions

• Schizophrenia Disorders
• Cognitive Dysfunction
• Emotion Regulation Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Remediation Therapy	CRT is a structured behavioral intervention consisting of weekly 60-minute sessions for 12 weeks. The therapy includes tasks to enhance cognitive skills such as attention, memory, executive function, and emotional regulation using computer-based training and therapist-guided exercises.

Timeline

• Start date: 2025-03-15
• Primary completion: 2025-08-15
• Completion: 2025-10-15
• First posted: 2025-04-20
• Last updated: 2025-04-20

Locations

1 site across 1 country: Turkey (Türkiye)