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

NCT06936397 | Recruiting

• 1 other identifier: CRT-SCHZ-IST-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia Disorders; Cognitive Dysfunction; Emotion Regulation Disorders

Keywords

Cognitive Remediation Therapy; Schizophrenia; EEG; GSR; Emotion Regulation; Executive Function; P300; Mismatch Negativity; Neurophysiological Biomarkers; Psychophysiology

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in P300 Amplitude Measured via EEG at 12 Weeks

  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.

  Baseline and 12 Weeks Post-Intervention

Secondary Outcomes (6)

• Change from Baseline in Mismatch Negativity (MMN) Amplitude Measured via EEG at 12 Weeks

  Baseline and 12 Weeks Post-Intervention

• Change from Baseline in Frontal Midline Theta Power During Cognitive Tasks at 12 Weeks

  Baseline and 12 Weeks Post-Intervention

• Change from Baseline in Skin Conductance Response (SCR) to Emotional Stimuli at 12 Weeks

  Baseline and 12 Weeks Post-Intervention

• Change from Baseline in Difficulties in Emotion Regulation Scale (DERS) Total Score at 12 Weeks

  Baseline and 12 Weeks Post-Intervention

• Change from Baseline in Brief Assessment of Cognition in Schizophrenia (BACS) Total Score at 12 Weeks

  Baseline and 12 Weeks Post-Intervention

Study Arms (2)

CRT Group

EXPERIMENTAL

Participants with schizophrenia assigned to receive 12 sessions of Cognitive Remediation Therapy (CRT) over 12 weeks. Each session lasts approximately 60 minutes and targets cognitive domains including attention, working memory, executive function, and emotion regulation.

Behavioral: Cognitive Remediation Therapy

Waitlist Control

NO INTERVENTION

Participants with schizophrenia assigned to a waitlist control group. They will not receive any therapy during the 12-week period but will undergo baseline and post-assessments similar to the CRT group.

Interventions

Cognitive Remediation Therapy BEHAVIORAL

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.

CRT Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with schizophrenia according to DSM-5 criteria
• Age between 18 and 55 years
• Clinically stable (no hospitalization or medication change within 1 month)
• Minimum primary school education
• Able to provide informed consent
• Right-handed (for EEG protocol consistency)
• No history of psychiatric or neurological disorders
• Age- and gender-matched to schizophrenia group
• No current medication affecting CNS
• Able to provide informed consent
• Right-handed

You may not qualify if:

• Current or past substance use disorder (within the past year)
• Comorbid neurological illness (e.g., epilepsy, traumatic brain injury)
• Current use of benzodiazepines or medications that significantly affect cognitive function
• Intellectual disability or MoCA score \< 20
• Visual or hearing impairments that could interfere with task performance
• Participation in a psychological intervention in the last 3 months

Sponsors & Collaborators

• Beykoz University: lead
• Uskudar University: collaborator
• Istanbul Nisantasi University: collaborator

Study Sites (1)

Beykoz University

Istanbul, 34820, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Cognitive Dysfunction; Emotional Regulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Gökben Hızlı Sayar, Professor

  Üsküdar University

  STUDY CHAIR

• Selami Varol Ülker, Phd

  Üsküdar University

  STUDY DIRECTOR

• Metin Çınaroğlu, Phd

  İstanbul Nişantaşı University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eda Yılmazer, Phd

CONTACT

00905322575880; edayilmazer@beykoz.edu.tr

Metin Çınaroğlu, Phd

CONTACT

00905324732070; metincinaroglu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Parallel assignment: Schizophrenia participants will be randomized into two groups (CRT intervention vs. waitlist control). Healthy controls will not receive an intervention but will serve as a normative reference group for baseline EEG and GSR measures.

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: April 20, 2025
• Study Start: March 15, 2025
• Primary Completion: August 15, 2025
• Study Completion: October 15, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available beginning 6 months after publication and for up to 5 years.
• Access Criteria: Researchers may request access by contacting the Principal Investigator.

Locations

TU (1)