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

Not Applicable

Recruiting

• Conditions: Schizophrenia Disorders; Cognitive Dysfunction; Emotion Regulation Disorders

• Registration Number: NCT06936397
• Lead Sponsor: Beykoz University

Brief 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.

Study Timeline

• Study Start: 2025-03-15
• Status Verified: 2025-04
• Study First Submitted: 2025-04-13
• Study First Submitted QC: 2025-04-13
• Last Update Submitted: 2025-04-13
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20
• Primary Completion: 2025-08-15
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline in P300 Amplitude Measured via EEG at 12 Weeks	Baseline and 12 Weeks Post-Intervention	P300 amplitude will be recorded during an auditory oddball task using EEG. Increased P300 amplitude after the 12-week CRT intervention is interpreted as an improvement in attentional processing and cognitive engagement. P300 is a continuous electrophysiological variable typically ranging from 0 to 15 microvolts; higher values post-intervention suggest enhanced neurocognitive performance.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Mismatch Negativity (MMN) Amplitude Measured via EEG at 12 Weeks	Baseline and 12 Weeks Post-Intervention	MMN amplitude will be measured during an auditory passive oddball paradigm to assess sensory discrimination and predictive coding. MMN is an event-related potential, with amplitudes typically ranging from 0 to -10 µV. Increased MMN amplitude post-intervention indicates improved auditory processing.
Change from Baseline in Frontal Midline Theta Power During Cognitive Tasks at 12 Weeks	Baseline and 12 Weeks Post-Intervention	Frontal theta power (4-8 Hz) will be extracted from EEG recordings during cognitive tasks such as the Stroop and n-back. Increases in theta power are associated with enhanced working memory and executive control.
Change from Baseline in Skin Conductance Response (SCR) to Emotional Stimuli at 12 Weeks	Baseline and 12 Weeks Post-Intervention	GSR responses to emotionally negative images will be measured. A decrease in SCR amplitude reflects reduced emotional hyperreactivity and improved autonomic regulation.
Change from Baseline in Difficulties in Emotion Regulation Scale (DERS) Total Score at 12 Weeks	Baseline and 12 Weeks Post-Intervention	Self-reported emotion regulation difficulties will be assessed using the Turkish-validated DERS. Scores range from 36 to 180, with higher scores indicating more severe regulation difficulties. A decrease in score post-intervention reflects improved regulation.
Change from Baseline in Brief Assessment of Cognition in Schizophrenia (BACS) Total Score at 12 Weeks	Baseline and 12 Weeks Post-Intervention	BACS assesses domains such as verbal memory, attention, working memory, and executive function. Higher scores post-intervention indicate improved cognitive performance.
Change from Baseline in Schizophrenia Quality of Life Scale (SQLS) Total Score at 12 Weeks	Baseline and 12 Weeks Post-Intervention	The SQLS measures subjective quality of life in schizophrenia. Lower total scores after CRT indicate improvements in psychological and social well-being.

Trial Locations

Locations (1)

Beykoz University; 🇹🇷 İstanbul, Turkey