A Randomized Controlled Trial Investigating the Effects of Cognitive-Behavioral Therapy on Neurophysiological and Psychological Outcomes in Individuals With Body Dysmorphic Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Visual Attention Patterns During Facial Stimulus Exposure
研究概览
简要总结
This clinical trial aims to investigate how a specific type of psychotherapy called Cognitive-Behavioral Therapy (CBT) can help people who experience Body Dysmorphic Disorder (BDD). BDD is a mental health condition where individuals become excessively preoccupied with perceived flaws in their physical appearance-flaws that are often unnoticeable to others. This distress can interfere significantly with their social, emotional, and daily functioning.
The purpose of this study is to evaluate whether a 12-week CBT program can reduce symptoms of BDD and bring about measurable changes in brain activity, physiological stress responses, and patterns of visual attention when individuals view their own faces or appearance-related images. The researchers will use brainwave recordings (EEG), skin response sensors (GSR), and eye-tracking technology to assess these changes. In addition, participants will complete a set of questionnaires that measure depression, anxiety, emotion regulation, self-esteem, body image beliefs, and self-compassion.
Sixty individuals will take part in the study. Thirty will receive CBT sessions once a week for 12 weeks, while the other thirty will be placed on a waitlist and offered treatment later. The study will compare how symptoms and neurophysiological responses change before and after therapy, and whether these changes differ between those who received immediate treatment and those who did not.
The researchers hypothesize that CBT will reduce emotional distress, improve emotion regulation, and shift brain and body responses toward healthier patterns. This study will help identify how and why therapy works for BDD, and whether technologies like EEG and eye-tracking can be used to monitor treatment progress.
详细描述
Detailed Description Background and Rationale Body Dysmorphic Disorder (BDD) is a chronic and often severely impairing psychiatric disorder characterized by intrusive preoccupations with perceived flaws in one's appearance-flaws that are often imperceptible to others. Individuals with BDD engage in compulsive behaviors such as mirror checking, grooming, or social avoidance, leading to functional impairment and heightened psychological distress. The condition has a high comorbidity with depression and anxiety, and individuals with BDD are at increased risk for suicidality.
Cognitive-Behavioral Therapy (CBT) is the most evidence-based intervention for BDD, targeting cognitive distortions, avoidance behaviors, and emotional dysregulation related to body image. However, despite robust clinical outcomes, the underlying neurophysiological mechanisms of CBT's effectiveness remain insufficiently explored. This trial seeks to address that gap by integrating behavioral symptom change with objective neurophysiological and attentional measures.
This study investigates whether a structured 12-week CBT program produces measurable improvements in brain function, autonomic nervous system response, and attentional bias among individuals with BDD. By combining EEG, GSR, and eye-tracking methods with validated clinical instruments, the research aims to clarify how therapy modulates both the subjective experience and biological correlates of body image disturbance.
Study Design This is a randomized controlled trial with a pre-post design involving two groups: a CBT intervention group and a waitlist control group. Sixty participants aged 18-50 will be recruited. Thirty participants will meet DSM-5 criteria for BDD and will be randomly assigned to either the CBT intervention group (n=15) or the waitlist control group (n=15). An additional healthy control group (n=30) will serve as a normative baseline for neurophysiological comparisons but will not receive any intervention.
The intervention consists of twelve 60-minute weekly CBT sessions focused on psychoeducation, cognitive restructuring, exposure and response prevention (ERP), mindfulness-based emotional regulation techniques, and attentional retraining exercises.
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
- None
盲法说明
No masking will be applied. Participants and researchers are aware of group assignments due to the structure of the intervention.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with Body Dysmorphic Disorder (BDD) according to DSM-5 criteria
- •Right-handed (to ensure consistency in EEG lateralization analyses)
- •Minimum education level of high school (for questionnaire comprehension)
- •Normal or corrected-to-normal vision (for eye-tracking calibration)
- •Willingness to participate in all therapy and assessment sessions
- •Signed written informed consent
排除标准
- •Current use of psychotropic medication
- •Current or past psychotherapy within the last 6 months
- •Diagnosis of schizophrenia, bipolar disorder, or substance use disorder
- •Neurological disorders (e.g., epilepsy, traumatic brain injury)
- •Active suicidal ideation or recent suicide attempt (within past 12 months)
- •Pregnancy (due to possible changes in physiological readings)
- •Any uncorrected visual impairments or eye conditions preventing eye-tracking
- •Presence of metal implants or devices incompatible with EEG recording
研究组 & 干预措施
Waitlist Control Group
Participants in this arm will receive no active intervention during the 12-week study period but will complete the same neurophysiological and psychometric assessments as the CBT group. After the final follow-up, they will be offered the CBT intervention if desired.
Cognitive-Behavioral Therapy (CBT) Group
Participants in this arm will receive 12 sessions of manualized Cognitive-Behavioral Therapy (CBT), each lasting 60 minutes, delivered weekly over 12 weeks. The therapy includes psychoeducation, cognitive restructuring, exposure and response prevention (ERP), mindfulness strategies, and attentional retraining related to appearance concerns.
干预措施: Cognitive-Behavioral Therapy (Behavioral)
结局指标
主要结局
Change in Visual Attention Patterns During Facial Stimulus Exposure
时间窗: Baseline, Week 12 (Post-treatment)
Visual attention responses will be measured using eye-tracking during exposure to self-related and appearance-based stimuli. The outcome includes the following integrated metrics: Fixation Duration (ms) Fixation Count (number) Saccade Frequency (number per second) Pupil Dilation (mm) These metrics will be collected via a Gazepoint GP3 eye-tracker, synchronized through iMotions, and analyzed in R and MATLAB. While each measure will be analyzed individually in secondary analyses, this outcome collectively reflects attentional allocation and hypervigilance. CBT is expected to reduce biased attention toward self-perceived flaws and normalize gaze patterns.
Change in EEG Responses to Appearance-Related Stimuli
时间窗: Baseline, Week 12 (Post-treatment)
Electroencephalographic (EEG) responses to appearance-related stimuli will be analyzed as a composite neurophysiological outcome, integrating the following components: N170 (early facial processing), P300 (attention allocation), Late Positive Potential - LPP (emotional engagement), and Frontal Alpha Asymmetry (affective regulation). All EEG signals will be recorded using a 14-channel EEG system and processed through synchronized pipelines in iMotions, MATLAB, and R. Each ERP component will be extracted, cleaned, and averaged across trials. Although individual metrics will be analyzed separately for exploratory purposes, the primary analytic approach will treat these variables as a conceptually unified outcome representing neurophysiological change. Statistical comparisons will be conducted using repeated-measures MANOVA and linear mixed-effects modeling to evaluate the impact of CBT over time.
Change in Galvanic Skin Response (GSR) to Appearance-Related Stimuli
时间窗: Baseline, Week 12 (Post-treatment)
Sympathetic nervous system activity will be measured using Galvanic Skin Response (GSR) during exposure to appearance-related stimuli. The outcome consists of two integrated components: Skin Conductance Level (SCL): baseline tonic arousal Skin Conductance Response (SCR): phasic reactivity to stimuli Both components will be simultaneously recorded using the iMotions platform, preprocessed in MATLAB, and statistically analyzed using R. Though each parameter will be evaluated individually, the primary outcome represents a composite measure of autonomic arousal regulation. CBT is expected to result in decreased SCR amplitude and faster return to baseline SCL, reflecting improved stress regulation.
次要结局
- Change in BDD Symptom Severity: Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder / YBOCS-BDD(Baseline, Week 12)
- Change in Body Image Disturbance Questionaire (BIDQ)(Baseline, Week 12)
- Change in Emotion Regulation Questionaire (ERQ)(Baseline, Week 12)
- Change in Depressive Symptoms (Beck Depression Inventory-II)(Baseline, Week 12)
- Change in Anxiety Symptoms (Beck Anxiety Inventory)(Baseline, Week 12)
研究者
Metin Çınaroğlu
Director
Istanbul Nisantasi University