Neurophysiological Effects of Cognitive Behavioral Therapy in the Treatment of Obsessive-Compulsive Disorder: An EEG Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change From Baseline in OCD Symptom Severity on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at Week 12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change From Baseline in OCD Symptom Severity on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at Week 12
时间窗: 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.
次要结局
- Changes in Resting-State EEG Brain Activity(Baseline, Week 12 (post-treatment), 3-month follow-up (Week 24))
- Change in ERP Component Amplitudes During EEG Tasks(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))
研究者
Selami Varol Ülker
Dr
Uskudar University