Cognitive Remediation Therapy for Schizophrenia: Effects on EEG and Emotional Regulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBeykoz University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Remediation Therapy
BehavioralCRT 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: CRT GroupExperimental treatment 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline and 12 Weeks Post-InterventionSecondary outcomes
1
Change from Baseline in Mismatch Negativity (MMN) Amplitude Measured via EEG at 12 Weeks
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.
Time frame
Baseline and 12 Weeks Post-Intervention2
Change from Baseline in Frontal Midline Theta Power During Cognitive Tasks at 12 Weeks
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.
Time frame
Baseline and 12 Weeks Post-Intervention3
Change from Baseline in Skin Conductance Response (SCR) to Emotional Stimuli at 12 Weeks
GSR responses to emotionally negative images will be measured. A decrease in SCR amplitude reflects reduced emotional hyperreactivity and improved autonomic regulation.
Time frame
Baseline and 12 Weeks Post-Intervention4
Change from Baseline in Difficulties in Emotion Regulation Scale (DERS) Total Score at 12 Weeks
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.
Time frame
Baseline and 12 Weeks Post-InterventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beykoz University
Lead sponsor
Uskudar University
Collaborator
Istanbul Nisantasi University
Collaborator
Source ClinicalTrials.gov