Schizophrenia DisordersCRT-SCHZNCT06936397
Cognitive Remediation Therapy for Schizophrenia: Effects on EEG and Emotional Regulation
A study testing Cognitive Remediation Therapy in people with Schizophrenia Disorders and Cognitive Dysfunction, run by Beykoz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia Disorders, Cognitive Dysfunction, Emotion Regulation Disorders
- What is being tested?
- Cognitive Remediation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Beykoz University
Istanbul, 34820
Eda Yılmazer, Phd, 00905322575880, edayilmazer@beykoz.edu.tr
Selami Varol Ülker, Phd, 00905364360941, selamivarol.ulker@uskudar.edu.tr
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Cognitive Remediation Therapy
- Keywords
- Cognitive Remediation Therapy, Schizophrenia, EEG, GSR, Emotion Regulation, Executive Function, P300, Mismatch Negativity, Neurophysiological Biomarkers, Psychophysiology
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Remediation TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CRT Group | Experimental | 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. Receives: Behavioral: Cognitive Remediation Therapy |
| Waitlist Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 Weeks Post-Intervention
Secondary outcomes (6)
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.
Measured: Baseline and 12 Weeks Post-Intervention
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.
Measured: Baseline and 12 Weeks Post-Intervention
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.
Measured: Baseline and 12 Weeks Post-Intervention
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.
Measured: Baseline and 12 Weeks Post-Intervention
Change from Baseline in Brief Assessment of Cognition in Schizophrenia (BACS) Total Score at 12 Weeks
BACS assesses domains such as verbal memory, attention, working memory, and executive function. Higher scores post-intervention indicate improved cognitive performance.
Measured: Baseline and 12 Weeks Post-Intervention
Change from Baseline in Schizophrenia Quality of Life Scale (SQLS) Total Score at 12 Weeks
The SQLS measures subjective quality of life in schizophrenia. Lower total scores after CRT indicate improvements in psychological and social well-being.
Measured: Baseline and 12 Weeks Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start15 Mar 2025
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment: Schizophrenia participants will be randomized into two groups (CRT intervention vs. waitlist control). Healthy controls will not receive an intervention but will serve as a normative reference group for baseline EEG and GSR measures.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beykoz University
- Sponsor type
- University, hospital or other
- Collaborators
- Uskudar University, Istanbul Nisantasi University
- Responsible party
- Principal investigator, Eda Yilmazer, Beykoz University
- Investigators
- Gökben Hızlı Sayar, Professor, Study chair, Üsküdar UniversitySelami Varol Ülker, Phd, Study director, Üsküdar UniversityMetin Çınaroğlu, Phd, Principal investigator, Istanbul Nisantasi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936397
- Sponsor's protocol ID
- CRT-SCHZ-IST-2025
- Acronym
- CRT-SCHZ
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to primary and secondary outcomes (e.g., EEG, GSR, and psychometric scores) will be shared.
Publications
Cinaroglu M, Yilmazer E, Ulker SV, Sayar GH. Neurophysiological and autonomic effects of Cognitive Remediation Therapy in schizophrenia: a randomized controlled EEG-GSR study. BMC Psychiatry. 2026 Aug 17;26(1):649. doi: 10.1186/s12888-026-08491-2.
PubMed 42625165
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled EEG-GSR Study on the Effects of Cognitive Remediation Therapy on Neurophysiological and Emotional Regulation Markers in Schizophrenia
- ClinicalTrials.gov ID
- NCT06936397
- Acronym / sponsor ID
- CRT-SCHZ / CRT-SCHZ-IST-2025
- Keywords
- Cognitive Remediation Therapy, Schizophrenia, EEG, GSR, Emotion Regulation, Executive Function, P300, Mismatch Negativity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beykoz UniversityUniversity, hospital or other
- Collaborators
- Uskudar University, Istanbul Nisantasi University
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment: Schizophrenia participants will be randomized into two groups (CRT intervention vs. waitlist control). Healthy controls will not receive an intervention but will serve as a normative reference group for baseline EEG and GSR measures.
| Arm | Type | Receives |
|---|---|---|
| CRT Group | Experimental | Behavioral: Cognitive Remediation TherapyParticipants 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. |
| Waitlist Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Remediation TherapyCRT 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. | Behavioural | CRT Group |
Primary outcome
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.
6 secondary outcomes
Change from Baseline in Mismatch Negativity (MMN) Amplitude Measured via EEG at 12 Weeks
Time frame: 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
Change from Baseline in Skin Conductance Response (SCR) to Emotional Stimuli at 12 Weeks
Time frame: 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
Change from Baseline in Brief Assessment of Cognition in Schizophrenia (BACS) Total Score at 12 Weeks
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Derived from this study: PubMed 42625165Cinaroglu M, Yilmazer E, Ulker SV, Sayar GH. Neurophysiological and autonomic effects of Cognitive Remediation Therapy in schizophrenia: a randomized controlled EEG-GSR study. BMC Psychiatry. 2026 Aug 17;26(1):649. doi: 10.1186/s12888-026-08491-2.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) related to primary and secondary outcomes (e.g., EEG, GSR, and psychometric scores) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gökben Hızlı Sayar, Professor study chair
Üsküdar University
Selami Varol Ülker, Phd study director
Üsküdar University
Metin Çınaroğlu, Phd principal investigator
Istanbul Nisantasi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation Therapy in people with Schizophrenia Disorders and Cognitive Dysfunction, run by Beykoz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eda Yılmazer, Phd (00905322575880, edayilmazer@beykoz.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in P300 Amplitude Measured via EEG at 12 Weeks (time frame: Baseline and 12 Weeks Post-Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06936397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.