Cognitive Remediation Therapy for Schizophrenia: Effects on EEG and Emotional Regulation (CRT-SCHZ)

April 13, 2025 updated by: Eda Yilmazer, Beykoz University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • İstanbul, Turkey, 34820
        • Recruiting
        • Beykoz University
        • Contact:
        • Contact:
          • Metin Çınaroğlu, Phd
        • Contact:
          • Selami Varol Ülker, Phd
        • Contact:
        • Contact:
          • Gökben Hızlı Sayar, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria (Schizophrenia Group):

  • 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)

Inclusion Criteria (Healthy Control Group):

  • 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 (Both Groups):

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in P300 Amplitude Measured via EEG at 12 Weeks
Time Frame: 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.
Baseline and 12 Weeks Post-Intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Mismatch Negativity (MMN) Amplitude Measured via EEG at 12 Weeks
Time Frame: 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.
Baseline and 12 Weeks Post-Intervention
Change from Baseline in Frontal Midline Theta Power During Cognitive Tasks at 12 Weeks
Time Frame: 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.
Baseline and 12 Weeks Post-Intervention
Change from Baseline in Skin Conductance Response (SCR) to Emotional Stimuli at 12 Weeks
Time Frame: 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.
Baseline and 12 Weeks Post-Intervention
Change from Baseline in Difficulties in Emotion Regulation Scale (DERS) Total Score at 12 Weeks
Time Frame: 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.
Baseline and 12 Weeks Post-Intervention
Change from Baseline in Brief Assessment of Cognition in Schizophrenia (BACS) Total Score at 12 Weeks
Time Frame: 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.
Baseline and 12 Weeks Post-Intervention
Change from Baseline in Schizophrenia Quality of Life Scale (SQLS) Total Score at 12 Weeks
Time Frame: 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.
Baseline and 12 Weeks Post-Intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beykoz University

Collaborators

Uskudar University
Istanbul Nisantasi University

Investigators

  • Study Chair: Gökben Hızlı Sayar, Professor, Uskudar University
  • Study Director: Selami Varol Ülker, Phd, Uskudar University
  • Principal Investigator: Metin Çınaroğlu, Phd, Istanbul Nişantaşı University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2025

Primary Completion (Estimated)

August 15, 2025

Study Completion (Estimated)

October 15, 2025

Study Registration Dates

First Submitted

April 13, 2025

First Submitted That Met QC Criteria

April 13, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 13, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRT-SCHZ-IST-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) related to primary and secondary outcomes (e.g., EEG, GSR, and psychometric scores) will be shared.

IPD Sharing Time Frame

Data will be available beginning 6 months after publication and for up to 5 years.

IPD Sharing Access Criteria

Researchers may request access by contacting the Principal Investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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