Obsessive-Compulsive DisorderCBT-OCD-EEGNCT07000812
EEG Evaluation of CBT for Obsessive-Compulsive Disorder
A study testing Cognitive Behavioral Therapy (CBT) in people with Obsessive-Compulsive Disorder, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
This clinical trial investigates how Cognitive Behavioral Therapy (CBT), a psychological treatment that helps people change their thought and behavior patterns, affects brain function in people diagnosed with Obsessive-Compulsive Disorder (OCD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Cognitive Behavioral Therapy (CBT)
- 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
- 1 Jan 2025to 25 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years
- Diagnosed with Obsessive-Compulsive Disorder (OCD) according to DSM-5 criteria
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score ≥16
- Not currently receiving psychiatric medication (at least 2-week washout required)
- No psychotherapy (including CBT) in the past 6 months
- Willing and able to participate in EEG procedures
- Capable of providing written informed consent
Who cannot join
- Use of any psychiatric medication in the past 2 weeks
- History of epilepsy, head trauma, or neurological disorders
- Current diagnosis of schizophrenia, bipolar disorder, or substance use disorder
- Severe physical illness or unstable medical condition
- Pregnancy or breastfeeding
- Prior CBT treatment for OCD within the past 6 months
- Currently participating in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurophysiological Effects of Cognitive Behavioral Therapy in the Treatment of Obsessive-Compulsive Disorder: An EEG Clinical Study
This clinical trial investigates how Cognitive Behavioral Therapy (CBT), a psychological treatment that helps people change their thought and behavior patterns, affects brain function in people diagnosed with Obsessive-Compulsive Disorder (OCD). OCD is characterized by repeated, unwanted thoughts (obsessions) and behaviors (compulsions) that significantly interfere with daily life.
Although CBT is known to effectively reduce OCD symptoms, exactly how it changes brain activity remains unclear. This study aims to measure the effects of CBT on brain function using electroencephalography (EEG), a safe, non-invasive way to monitor brain activity.
Read more
Participants diagnosed with OCD will be randomly assigned to two groups. One group will receive CBT consisting of 12 individual therapy sessions, held weekly, lasting about 50 minutes each. The other group will not receive therapy during the study but will be offered treatment afterward. Brain activity and psychological well-being will be measured three times: before starting treatment, immediately after completing CBT, and again three months later.
By comparing these two groups, the study hopes to answer whether CBT causes measurable changes in brain activity and how these changes relate to improvements in OCD symptoms. Results from this study could help improve future treatments and understanding of OCD.
Read the detailed description
Obsessive-Compulsive Disorder (OCD) is a psychiatric condition marked by persistent, distressing obsessions (intrusive thoughts) and compulsions (repetitive behaviors aimed at relieving anxiety). Cognitive Behavioral Therapy (CBT), particularly with Exposure and Response Prevention (ERP), is established as an effective treatment method. However, the exact neurophysiological mechanisms underlying CBT-induced symptom improvement in OCD patients remain unclear.
This randomized controlled clinical trial aims to clarify these mechanisms by examining how CBT impacts brain functioning through neurophysiological assessments using electroencephalography (EEG). EEG is a reliable and non-invasive method for measuring brain electrical activity, particularly valuable for observing real-time brain responses to various cognitive tasks and resting-state conditions.
The trial will recruit 60 adult OCD patients (aged 18-65) diagnosed according to DSM-5 criteria from outpatient psychiatric clinics in Istanbul, Turkey. After baseline assessments, participants will be randomly assigned equally into two groups:
Intervention Group (CBT): Participants will receive 12 weekly sessions of individual CBT, each lasting 50 minutes. The CBT protocol includes standard therapeutic techniques such as ERP, cognitive restructuring, identification of maladaptive beliefs, psychoeducation, and relapse prevention strategies.
Control Group: Participants will be placed on a waiting list and will not receive any intervention during the active study period. CBT will be offered to these participants after study completion.
Participants in both groups will undergo comprehensive EEG assessments at three different time points: at baseline (pre-treatment), immediately following the CBT intervention (12 weeks post-baseline), and at a three-month follow-up (24 weeks post-baseline). EEG sessions will include:
Resting-State EEG (eyes closed):
Duration: 10-minute continuous recording.
Analysis Method: Low-Resolution Brain Electromagnetic Tomography (LORETA) to identify cortical activity patterns, specifically focusing on alpha-2 and beta frequency bands within regions implicated in OCD, such as the anterior cingulate cortex (ACC) and orbitofrontal cortex (OFC).
Emotional Oddball Paradigm:
Stimuli: Anxiety-provoking and neutral images or words presented randomly.
EEG measure: Event-Related Potentials (ERPs), particularly P300 amplitude and latency, to investigate attentional allocation and emotional processing alterations associated with OCD pathology and potential CBT-induced normalization.
Go/No-Go Task:
Purpose: Evaluate inhibitory control mechanisms and cognitive flexibility.
EEG measure: ERPs such as Error-Related Negativity (ERN), N2 (conflict monitoring), and P3 (response inhibition), known to be altered in OCD populations. This task will clarify whether CBT influences cognitive control functions at a neural level.
In addition to EEG, participants will complete several validated clinical measures at each time point to evaluate OCD symptom severity, anxiety, and depression levels. These scales include the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), Obsessive-Compulsive Inventory-Revised (OCI-R), Beck Depression Inventory-II (BDI-II), and Beck Anxiety Inventory (BAI).
EEG data will undergo rigorous preprocessing steps (bandpass filtering, independent component analysis for artifact removal, and segmentation into epochs) followed by ERP analysis using standardized software. Statistical comparisons will employ repeated measures ANOVA and linear mixed-effects models to identify significant differences between groups and across time points. Correlation analyses will examine the relationships between clinical improvements and neurophysiological changes observed via EEG.
Ultimately, this research aims to provide greater understanding of the biological processes underlying CBT effectiveness, potentially informing future targeted treatments and personalized therapeutic strategies for OCD.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Cognitive Behavioral Therapy (CBT)
- Keywords
- Cognitive Behavioral Therapy, EEG, Neurophysiology, ERP (Exposure and Response Prevention), OCD
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
Participants in the intervention arm receive 12 weekly sessions of individual CBT. Therapy includes exposure and response prevention, cognitive restructuring, psychoeducation, and relapse prevention strategies.
| Study group | Role | What they receive |
|---|---|---|
| CBT Intervention Group | Experimental | Participants receive 12 weekly individual Cognitive Behavioral Therapy (CBT) sessions, each session lasting approximately 50 minutes. CBT includes Exposure and Response Prevention (ERP), cognitive restructuring, psychoeducation, and relapse prevention strategies. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| Waiting List Control | No intervention | Participants receive no intervention during the 12-week treatment period but are offered CBT treatment after the completion of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in OCD Symptom Severity on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at Week 12
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) measures severity of obsessive-compulsive symptoms. The total score ranges from 0 (no symptoms) to 40 (extreme severity), with higher scores indicating greater OCD symptom severity.
Measured: Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)
Secondary outcomes (5)
Change in ERP Component Amplitudes During EEG Tasks
This outcome captures changes in Event-Related Potential (ERP) amplitudes recorded during cognitive tasks. Components include P300 amplitude during the emotional oddball task, and ERN, N2, and P3 amplitudes during the Go/No-Go task. These amplitudes are measured in microvolts (µV) and reflect neural responses to emotional and inhibitory stimuli.
Measured: Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)
Changes in Resting-State EEG Brain Activity
Differences in resting-state EEG activity (LORETA-based cortical activity in alpha-2 and beta bands in ACC and OFC) from baseline to post-treatment and follow-up.
Measured: Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)
Change in Depression Symptoms
Change from baseline in depressive symptoms as measured by Beck Depression Inventory-II (BDI-II). Scores range from 0 (minimal depression) to 63 (severe depression), with higher scores indicating greater depressive symptomatology.
Measured: Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)
Change in Anxiety Symptoms
Change from baseline in anxiety levels measured by Beck Anxiety Inventory (BAI). Scores range from 0 (minimal anxiety) to 63 (severe anxiety), higher scores indicate greater anxiety severity.
Measured: Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)
Change in ERP Component Latencies During EEG Tasks
This outcome captures changes in Event-Related Potential (ERP) latencies recorded during EEG-based cognitive tasks. Latencies of P300 (emotional oddball task), and N2 and P3 (Go/No-Go task) will be assessed. Measured in milliseconds (ms), these values reflect the timing of cognitive-emotional responses.
Measured: Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Jan 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion25 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 Obsessive-Compulsive DisorderStudies 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
- Participants are randomly assigned to one of two parallel groups: CBT treatment group or waiting list control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Nisantasi University, Beykoz University
- Responsible party
- Principal investigator, Selami Varol Ülker, Uskudar University
- Investigators
- Eda Yılmazer, Phd, Principal investigator, Beykoz UniversityMetin Çınaroğlu, Phd, Principal investigator, Istanbul Nisantasi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000812
- Sponsor's protocol ID
- 61351342/020-674
- Acronym
- CBT-OCD-EEG
- Status last verified
- Jun 2025
- First submitted
- 7 Apr 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cinaroglu M, Ulker SV, Yilmazer E, Sayar GH. Neural correlates of response inhibition following cognitive behavioral therapy in obsessive-compulsive disorder: a randomized controlled EEG study. BMC Psychol. 2026 Aug 10;14(1):1323. doi: 10.1186/s40359-026-05201-1.
PubMed 42723132
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Effects of Cognitive Behavioral Therapy in the Treatment of Obsessive-Compulsive Disorder: An EEG Clinical Study
- ClinicalTrials.gov ID
- NCT07000812
- Acronym / sponsor ID
- CBT-OCD-EEG / 61351342/020-674
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Cognitive Behavioral Therapy, EEG, Neurophysiology, ERP (Exposure and Response Prevention), OCD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Collaborators
- Istanbul Nisantasi University, Beykoz University
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 25 Oct 2025 (estimated)
- First posted
- 3 Jun 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 clinical trial investigates how Cognitive Behavioral Therapy (CBT), a psychological treatment that helps people change their thought and behavior patterns, affects brain function in people diagnosed with Obsessive-Compulsive Disorder (OCD). OCD is characterized by repeated, unwanted thoughts (obsessions) and behaviors (compulsions) that significantly interfere with daily life.
Although CBT is known to effectively reduce OCD symptoms, exactly how it changes brain activity remains unclear. This study aims to measure the effects of CBT on brain function using electroencephalography (EEG), a safe, non-invasive way to monitor brain activity.
Participants diagnosed with OCD will be randomly assigned to two groups. One group will receive CBT consisting of 12 individual therapy sessions, held weekly, lasting about 50 minutes each. The other group will not receive therapy during the study but will be offered treatment afterward. Brain activity and psychological well-being will be measured three times: before starting treatment, immediately after completing CBT, and again three months later.
By comparing these two groups, the study hopes to answer whether CBT causes measurable changes in brain activity and how these changes relate to improvements in OCD symptoms. Results from this study could help improve future treatments and understanding of OCD.
Detailed description
Obsessive-Compulsive Disorder (OCD) is a psychiatric condition marked by persistent, distressing obsessions (intrusive thoughts) and compulsions (repetitive behaviors aimed at relieving anxiety). Cognitive Behavioral Therapy (CBT), particularly with Exposure and Response Prevention (ERP), is established as an effective treatment method. However, the exact neurophysiological mechanisms underlying CBT-induced symptom improvement in OCD patients remain unclear.
This randomized controlled clinical trial aims to clarify these mechanisms by examining how CBT impacts brain functioning through neurophysiological assessments using electroencephalography (EEG). EEG is a reliable and non-invasive method for measuring brain electrical activity, particularly valuable for observing real-time brain responses to various cognitive tasks and resting-state conditions.
The trial will recruit 60 adult OCD patients (aged 18-65) diagnosed according to DSM-5 criteria from outpatient psychiatric clinics in Istanbul, Turkey. After baseline assessments, participants will be randomly assigned equally into two groups:
Intervention Group (CBT): Participants will receive 12 weekly sessions of individual CBT, each lasting 50 minutes. The CBT protocol includes standard therapeutic techniques such as ERP, cognitive restructuring, identification of maladaptive beliefs, psychoeducation, and relapse prevention strategies.
Control Group: Participants will be placed on a waiting list and will not receive any intervention during the active study period. CBT will be offered to these participants after study completion.
Participants in both groups will undergo comprehensive EEG assessments at three different time points: at baseline (pre-treatment), immediately following the CBT intervention (12 weeks post-baseline), and at a three-month follow-up (24 weeks post-baseline). EEG sessions will include:
Resting-State EEG (eyes closed):
Duration: 10-minute continuous recording.
Analysis Method: Low-Resolution Brain Electromagnetic Tomography (LORETA) to identify cortical activity patterns, specifically focusing on alpha-2 and beta frequency bands within regions implicated in OCD, such as the anterior cingulate cortex (ACC) and orbitofrontal cortex (OFC).
Emotional Oddball Paradigm:
Stimuli: Anxiety-provoking and neutral images or words presented randomly.
EEG measure: Event-Related Potentials (ERPs), particularly P300 amplitude and latency, to investigate attentional allocation and emotional processing alterations associated with OCD pathology and potential CBT-induced normalization.
Go/No-Go Task:
Purpose: Evaluate inhibitory control mechanisms and cognitive flexibility.
EEG measure: ERPs such as Error-Related Negativity (ERN), N2 (conflict monitoring), and P3 (response inhibition), known to be altered in OCD populations. This task will clarify whether CBT influences cognitive control functions at a neural level.
In addition to EEG, participants will complete several validated clinical measures at each time point to evaluate OCD symptom severity, anxiety, and depression levels. These scales include the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), Obsessive-Compulsive Inventory-Revised (OCI-R), Beck Depression Inventory-II (BDI-II), and Beck Anxiety Inventory (BAI).
EEG data will undergo rigorous preprocessing steps (bandpass filtering, independent component analysis for artifact removal, and segmentation into epochs) followed by ERP analysis using standardized software. Statistical comparisons will employ repeated measures ANOVA and linear mixed-effects models to identify significant differences between groups and across time points. Correlation analyses will examine the relationships between clinical improvements and neurophysiological changes observed via EEG.
Ultimately, this research aims to provide greater understanding of the biological processes underlying CBT effectiveness, potentially informing future targeted treatments and personalized therapeutic strategies for OCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two parallel groups: CBT treatment group or waiting list control group.
| Arm | Type | Receives |
|---|---|---|
| CBT Intervention Group | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT)Participants receive 12 weekly individual Cognitive Behavioral Therapy (CBT) sessions, each session lasting approximately 50 minutes. CBT includes Exposure and Response Prevention (ERP), cognitive restructuring, psychoeducation, and relapse prevention strategies. |
| Waiting List Control | No intervention | –Participants receive no intervention during the 12-week treatment period but are offered CBT treatment after the completion of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged between 18 and 65 years
- Diagnosed with Obsessive-Compulsive Disorder (OCD) according to DSM-5 criteria
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score ≥16
- Not currently receiving psychiatric medication (at least 2-week washout required)
- No psychotherapy (including CBT) in the past 6 months
Key exclusion criteria (7 listed)
- Use of any psychiatric medication in the past 2 weeks
- History of epilepsy, head trauma, or neurological disorders
- Current diagnosis of schizophrenia, bipolar disorder, or substance use disorder
- Severe physical illness or unstable medical condition
- Pregnancy or breastfeeding
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 Behavioral Therapy (CBT)Participants in the intervention arm receive 12 weekly sessions of individual CBT. Therapy includes exposure and response prevention, cognitive restructuring, psychoeducation, and relapse prevention strategies. | Behavioural | CBT Intervention Group |
Primary outcome
Change From Baseline in OCD Symptom Severity on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at Week 12
Time frame: Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) measures severity of obsessive-compulsive symptoms. The total score ranges from 0 (no symptoms) to 40 (extreme severity), with higher scores indicating greater OCD symptom severity.
5 secondary outcomes
Change in ERP Component Amplitudes During EEG Tasks
Time frame: Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)
Changes in Resting-State EEG Brain Activity
Time frame: Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)
Change in Depression Symptoms
Time frame: Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)
Change in Anxiety Symptoms
Time frame: Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)
Change in ERP Component Latencies During EEG Tasks
Time frame: Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)
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 3 Jun 2025.
- Derived from this study: PubMed 42723132Cinaroglu M, Ulker SV, Yilmazer E, Sayar GH. Neural correlates of response inhibition following cognitive behavioral therapy in obsessive-compulsive disorder: a randomized controlled EEG study. BMC Psychol. 2026 Aug 10;14(1):1323. doi: 10.1186/s40359-026-05201-1.
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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. This study is not recruiting at the moment.
Eda Yılmazer, Phd principal investigator
Beykoz 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 Behavioral Therapy (CBT) in people with Obsessive-Compulsive Disorder, run by Uskudar 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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 3 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in OCD Symptom Severity on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at Week 12 (time frame: Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)). 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 NCT07000812, 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 3 Jun 2025.