Loading clinical trials...
Loading clinical trials...
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.
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.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
Yes
Beykoz University
Istanbul, Turkey (Türkiye)
Start Date
March 15, 2025
Primary Completion Date
August 15, 2025
Completion Date
October 15, 2025
Last Updated
April 20, 2025
60
ESTIMATED participants
Cognitive Remediation Therapy
BEHAVIORAL
Lead Sponsor
Beykoz University
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06641297