CBT Effects on Neural, Physiological, and Attentional Responses in Anorexia Nervosa

NCT ID: NCT07037017

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2025-10-15

Brief Summary

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.

Detailed Description

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.

Conditions

Eating Disorders (Excluding Anorexia Nervosa)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT Intervention Group

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.

Group Type: EXPERIMENTAL

Cognitive-Behavioral Therapy

Intervention Type: BEHAVIORAL

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.

Waitlist Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Uskudar University

OTHER

Sponsor Role: collaborator

Beykoz University

OTHER

Sponsor Role: collaborator

Istanbul Nisantasi University

OTHER

Sponsor Role: lead

Responsible Party

Metin Çınaroğlu

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gökben Hızlı Sayar, Professor

Role: STUDY_CHAIR

Üsküdar University

Eda Yılmazer, Phd

Role: STUDY_DIRECTOR

Beykoz University

Locations

Üsküdar University Neuro Marketing Lab.

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Metin Çınaroğlu, Phd

Role: CONTACT

metincinaroglu@gmail.com

00905324732070

Selami Varol Ülker, Phd

Role: CONTACT

selamivarol.ulker@uskudar.edu.tr

00905364360941

Facility Contacts

Selami Varol Ülker, phd

Role: primary

selamivarol.ulker@uskudar.edu.tr

00905364360941

Gökben Hızlı Sayar, Professor

Role: backup

gokben.hizlisayar@uskudar.edu.tr

00905302441316

Other Identifiers

AN-CBT-EEG-2025

Identifier Type: -

Identifier Source: org_study_id