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

NCT ID: NCT06936397

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2025-10-15

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.

Conditions

Schizophrenia Disorders; Cognitive Dysfunction; Emotion Regulation Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CRT Group

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.

Group Type: EXPERIMENTAL

Cognitive Remediation Therapy

Intervention Type: 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.

Waitlist Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uskudar University

OTHER

Sponsor Role: collaborator

Istanbul Nisantasi University

OTHER

Sponsor Role: collaborator

Beykoz University

OTHER

Sponsor Role: lead

Responsible Party

Eda Yilmazer

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gökben Hızlı Sayar, Professor

Role: STUDY_CHAIR

Üsküdar University

Selami Varol Ülker, Phd

Role: STUDY_DIRECTOR

Üsküdar University

Metin Çınaroğlu, Phd

Role: PRINCIPAL_INVESTIGATOR

İstanbul Nişantaşı University

Locations

Beykoz University

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Eda Yılmazer, Phd

Role: CONTACT

edayilmazer@beykoz.edu.tr

00905322575880

Metin Çınaroğlu, Phd

Role: CONTACT

metincinaroglu@gmail.com

00905324732070

Facility Contacts

Eda Yılmazer, Phd

Role: primary

edayilmazer@beykoz.edu.tr

00905322575880

Selami Varol Ülker, Phd

Role: backup

selamivarol.ulker@uskudar.edu.tr

00905364360941

Other Identifiers

CRT-SCHZ-IST-2025

Identifier Type: -

Identifier Source: org_study_id