CBT Effects on Neural, Physiological, and Attentional Responses in Anorexia Nervosa
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Cognitive-Behavioral Therapy.
- Кому может быть актуально
- Состояния в реестре: Eating Disorders (Excluding Anorexia Nervosa). Базовые параметры: 18 лет — 35 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Turkey (Türkiye)
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Neurophysiological Effects of Cognitive-Behavioral Therapy in Anorexia Nervosa: A Pre-Post EEG, GSR, and Eye-Tracking Study
Обзор
This randomized controlled trial investigates the neurophysiological, physiological, and attentional effects of Cognitive-Behavioral Therapy (CBT) in individuals with restrictive-type anorexia nervosa (AN). The study compares two groups: one receiving a 12-week CBT intervention, and one placed on a waitlist (no active treatment during the study period). All participants undergo pre- and post-intervention assessments using electroencephalography (EEG), galvanic skin response (GSR), and eye-tracking while exposed to visual stimuli related to food, body image, and self-appearance. The primary outcomes include neural changes in attention and emotional processing (P300, LPP, frontal alpha asymmetry), physiological arousal (skin conductance), and visual attention biases (fixation duration and gaze distribution). The aim is to determine whether CBT leads to measurable improvements in neurobiological and attentional mechanisms related to body image disturbance and food-related anxiety in AN, contributing to biomarker-informed psychotherapy approaches.
Подробное описание
Anorexia nervosa (AN) is a severe psychiatric disorder characterized by distorted body image, food restriction, and intense fear of weight gain. Despite the effectiveness of Cognitive-Behavioral Therapy (CBT) in targeting maladaptive cognitions and behaviors, its underlying neurophysiological mechanisms remain insufficiently understood. This study aims to evaluate the effects of a 12-week CBT intervention on neural, physiological, and attentional responses in individuals with restrictive-type AN using a randomized controlled trial design.
Sixty female participants (aged 18-35) with restrictive-type AN will be recruited and randomly assigned to one of two groups: a CBT intervention group (n = 30) and a waitlist control group (n = 30). Both groups will undergo baseline and post-intervention assessments using EEG, GSR, and eye-tracking. The CBT intervention will consist of weekly 60-minute sessions for 12 weeks, delivered by trained therapists, and will target body image distortion, cognitive restructuring, exposure to food-related stimuli, emotional regulation, and avoidance behaviors.
During the experimental task, participants will view a series of visual stimuli including (1) self-images (unaltered, altered-thin, altered-overweight), (2) food images (low- vs. high-calorie), and (3) images of other female bodies (thin vs. normal weight). EEG markers of interest include P300 (attentional salience), Late Positive Potential (LPP; sustained emotional reactivity), and frontal alpha asymmetry (indicative of affect regulation and self-referential processing). It is hypothesized that CBT will lead to reductions in P300 and LPP amplitudes and an increase in left-frontal cortical activity, indicating enhanced emotional control and reduced fixation on thin-ideal stimuli.
GSR will be used to assess physiological arousal in response to distressing stimuli. It is expected that post-CBT participants will exhibit lower skin conductance responses (SCRs) to body and food images, indicating improved autonomic regulation. Eye-tracking data will capture fixation durations and gaze patterns. Participants in the CBT group are expected to show less visual attention toward "problematic" body areas (waist, stomach, thighs) and reduced avoidance of high-calorie food images compared to the waitlist group.
Participants will also complete standardized psychometric instruments including the Eating Disorder Examination Questionnaire (EDE-Q), Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), the Yale-Brown Obsessive-Compulsive Scale for Body Dysmorphic Disorder (YBOCS-BDD), and the Cognitive Emotion Regulation Questionnaire (CERQ) at both time points.
This trial will provide critical insights into the neurophysiological and attentional mechanisms of CBT in AN, aiming to identify objective biomarkers of therapeutic change. Results may inform precision-based treatment models and support the development of digitally enhanced or neuromodulation-augmented therapies for eating disorders.
Вмешательства
- Поведенческое Cognitive-Behavioral Therapy
Manualized 12-week CBT protocol focused on reducing body image disturbance, distorted beliefs about food and appearance, and avoidance behaviors in individuals with anorexia nervosa. The intervention incorporates psychoeducation, cognitive restructuring, emotional regulation, food exposure, and body image work.
Первичные конечные точки
- Change in EEG P300 amplitude in response to body image stimuli [Срок оценки: aseline and Week 12]
- Change in Late Positive Potential (LPP) amplitude to body and food stimuli [Срок оценки: Baseline and Week 12]
- Change in frontal alpha asymmetry during self-image viewing [Срок оценки: Baseline and Week 12]
- Change in skin conductance response (SCR) to body and food stimuli [Срок оценки: Baseline and Week 12]
- Change in fixation duration on weight-related body areas [Срок оценки: Baseline and Week 12 Baseline and Week 12]
Вторичные конечные точки (6)
- Change in Eating Disorder Examination Questionnaire (EDE-Q) scores [Срок оценки: Baseline and Week 12]
- Change in Beck Depression Inventory-II (BDI-II) scores [Срок оценки: Baseline and Week 12]
- Change in Beck Anxiety Inventory (BAI) scores [Срок оценки: Baseline and Week 12]
- Change in Yale-Brown Obsessive Compulsive Scale - Body Dysmorphic Disorder Version (YBOCS-BDD) scores [Срок оценки: Baseline and Week 12]
- Change in Cognitive Emotion Regulation Questionnaire (CERQ) scores [Срок оценки: Baseline and Week 12]
- Change in subjective distress ratings on Visual Analog Scale (VAS) [Срок оценки: Immediately after the experimental task at both baseline and Week 12]
Критерии участия
Критерии включения
- Female participants aged 18 to 35
- Meeting DSM-5 diagnostic criteria for restrictive-type anorexia nervosa
- Body Mass Index (BMI) between 15.0 and 18.5
- Medically stable to participate in psychological and neurophysiological assessments
- Willingness to participate in weekly therapy sessions (for the CBT group) and to complete pre- and post-assessments
- Ability to provide informed consent
Критерии исключения
- Current or past diagnosis of bulimia nervosa, binge-eating disorder, or other eating disorders
- Presence of comorbid severe psychiatric disorders (e.g., psychosis, bipolar disorder, substance use disorder)
- History of neurological illness or traumatic brain injury
- Use of psychotropic medication within the last 6 weeks
- Prior participation in structured Cognitive-Behavioral Therapy for an eating disorder
- Pregnancy
- Visual or neurological impairments that would prevent accurate EEG, GSR, or eye-tracking recordings
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Turkey (Türkiye) · 1 центр
- Üsküdar University Neuro Marketing Lab. — Istanbul
Публикации
- Yilmazer E, Cinaroglu M, Ulker SV, Hizli Sayar G. Cognitive Behavioral Therapy Reduces Symptom Severity and Normalizes Neurophysiological and Attentional Reactivity in Anorexia Nervosa: A Randomized Controlled Trial. Brain Sci. 2026 Mar 13;16(3):309. doi: 10.3390/brainsci16030309. PMID 41892652
Идентификаторы
NCT: NCT07037017 · AN-CBT-EEG-2025