EEG Evaluation of CBT for Obsessive-Compulsive Disorder

NCT07000812 | Active Not Recruiting

• 1 other identifier: 61351342/020-674
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Cognitive Behavioral Therapy; EEG; Neurophysiology; ERP (Exposure and Response Prevention); OCD

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)

Secondary Outcomes (5)

• Change in ERP Component Amplitudes During EEG Tasks

  Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)

• Changes in Resting-State EEG Brain Activity

  Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)

• Change in Depression Symptoms

  Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)

• Change in Anxiety Symptoms

  Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)

• Change in ERP Component Latencies During EEG Tasks

  Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24)

Study Arms (2)

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.

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.

Interventions

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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.

CBT Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uskudar University: lead
• Istanbul Nisantasi University: collaborator
• Beykoz University: collaborator

Study Sites (1)

Üsküdar University

Istanbul, 34674, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Eda Yılmazer, Phd

  Beykoz University

  PRINCIPAL INVESTIGATOR

• Metin Çınaroğlu, Phd

  Istanbul Nisantasi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor conducting EEG assessments and psychological evaluations is blinded to group assignment. Participants and therapists cannot be blinded due to the nature of the psychotherapy intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Participants are randomly assigned to one of two parallel groups: CBT treatment group or waiting list control group.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: June 3, 2025
• Study Start: January 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 25, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-06

Locations

TU (1)