Neurophysiological Effects of Cognitive-Behavioral Therapy in Anorexia Nervosa: A Pre-Post EEG, GSR, and Eye-Tracking Study
Sponsor study identifier
interventional
60
1 country
1
Study Start
May 15, 2025
Actual (reported)Primary Completion
September 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 15, 2025
Actual (reported)June 17, 2025
Actual (reported)June 25, 2025
Actual (reported)September 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in EEG P300 amplitude in response to body image stimuli
P300 amplitudes will be extracted from EEG data during visual exposure to body image stimuli. Reduced amplitudes post-CBT are hypothesized to indicate reduced attentional salience and hyperfocus on appearance-related cues. P300 amplitudes will be extracted from EEG data during visual exposure to body image stimuli. Reduced amplitudes post-CBT are hypothesized to indicate reduced attentional salience and hyperfocus on appearance-related cues.
aseline and Week 12
Change in Late Positive Potential (LPP) amplitude to body and food stimuli
LPP amplitudes will be measured during viewing of thin, overweight, and food-related images. A reduction post-CBT suggests decreased sustained emotional reactivity to distressing visual input.
Baseline and Week 12
Change in frontal alpha asymmetry during self-image viewing
Frontal alpha asymmetry (FAA), computed from EEG data, will be used to index emotional regulation. An increase in left-dominant FAA is expected post-CBT, reflecting enhanced emotional control and positive self-perception.
Baseline and Week 12
Change in Eating Disorder Examination Questionnaire (EDE-Q) scores
Baseline and Week 12
Change in Beck Depression Inventory-II (BDI-II) scores
Baseline and Week 12
Change in Beck Anxiety Inventory (BAI) scores
Baseline and Week 12
Change in Yale-Brown Obsessive Compulsive Scale - Body Dysmorphic Disorder Version (YBOCS-BDD) scores
Baseline and Week 12
Change in Cognitive Emotion Regulation Questionnaire (CERQ) scores
Baseline and Week 12
Participants diagnosed with restrictive-type anorexia nervosa will receive 12 weekly individual Cognitive-Behavioral Therapy (CBT) sessions. Each session will last approximately 60 minutes and be delivered by a trained therapist. The CBT protocol targets body image distortion, cognitive restructuring of maladaptive beliefs, exposure to food-related stimuli, emotional regulation strategies, and behavioral experiments to reduce avoidance. Pre- and post-treatment neurophysiological (EEG), physiological (GSR), and attentional (eye-tracking) assessments will be conducted.
Participants diagnosed with restrictive-type anorexia nervosa will be placed on a waitlist and will not receive any structured psychological intervention during the 12-week study period. They will complete the same neurophysiological (EEG), physiological (GSR), and attentional (eye-tracking) assessments at baseline and at the 12-week follow-up.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Üsküdar University Neuro Marketing Lab.
Istanbul, Turkey (Türkiye)
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.
Gökben Hızlı Sayar, Professor
Üsküdar University
Eda Yılmazer, Phd
Beykoz University
First Submitted
June 17, 2025
First Posted
June 25, 2025
Study Start
May 15, 2025
Actual (reported)Group-based Cognitive-behavioral Therapy for Adults With Attention-deficit/Hyperactivity Disorder Inattentive-type
Change in skin conductance response (SCR) to body and food stimuli
Skin conductance responses will be measured via GSR during visual exposure to self-body, other-body, and food stimuli. Decreased SCR amplitudes post-CBT will indicate reduced physiological arousal and distress.
Baseline and Week 12
Change in fixation duration on weight-related body areas
Eye-tracking will assess gaze fixation duration on areas of interest (waist, thighs, stomach). Post-CBT reductions in fixation on these regions suggest reduced attentional bias toward body dissatisfaction zones.
Baseline and Week 12 Baseline and Week 12
Contact the study team to confirm eligibility.
Primary Completion
September 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 25, 2025
Record last verified: 2025-06
De-identified individual participant data (IPD) for all primary and secondary outcome measures (EEG, GSR, eye-tracking, and psychometric scores) will be shared upon reasonable request. Data will be shared in compliance with institutional ethics and data protection regulations.
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Source: ClinicalTrials.gov.
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