Cognitive Remediation Therapy for Schizophrenia: Effects on EEG and Emotional Regulation (NCT06936397) | Clinical Trial Compass
RecruitingNot Applicable
Cognitive Remediation Therapy for Schizophrenia: Effects on EEG and Emotional Regulation
Turkey (Türkiye)60 participantsStarted 2025-03-15
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in P300 Amplitude Measured via EEG at 12 Weeks
Timeframe: Baseline and 12 Weeks Post-Intervention