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Eating Disorders (Excluding Anorexia Nervosa)NCT07037017

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

A study testing Cognitive-Behavioral Therapy in people with Eating Disorders (Excluding Anorexia Nervosa), run by Istanbul Nisantasi University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 35 years, women only
What is being tested?
Cognitive-Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 May 2025to 15 Oct 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Metin Çınaroğlu, Phd contact

00905324732070

metincinaroglu@gmail.com

Selami Varol Ülker, Phd contact

00905364360941

selamivarol.ulker@uskudar.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Üsküdar University Neuro Marketing Lab.

    Istanbul

    Selami Varol Ülker, phd, 00905364360941, selamivarol.ulker@uskudar.edu.tr

    Gökben Hızlı Sayar, Professor, 00905302441316, gokben.hizlisayar@uskudar.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Neurophysiological Effects of Cognitive-Behavioral Therapy in Anorexia Nervosa: A Pre-Post EEG, GSR, and Eye-Tracking Study

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.

Read the 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.

Keywords
Cognitive Behavioral Therapy (CBT), EEG, Eye-Tracking, Galvanic Skin Response (GSR), Body Image
Medical subject headings
Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive-Behavioral TherapyBehavioural

    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.

Study groups in NCT07037017
Study groupRoleWhat they receive
CBT Intervention GroupExperimentalParticipants 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.
Receives: Behavioral: Cognitive-Behavioral Therapy
Waitlist Control GroupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: aseline and Week 12

  2. 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.

    Measured: Baseline and Week 12

  3. 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.

    Measured: Baseline and Week 12

  4. 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.

    Measured: Baseline and Week 12

  5. 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.

    Measured: Baseline and Week 12 Baseline and Week 12

Secondary outcomes (6)
  1. Change in Eating Disorder Examination Questionnaire (EDE-Q) scores

    The EDE-Q assesses eating disorder symptoms across four subscales: Restraint, Eating Concern, Weight Concern, and Shape Concern. Each item is rated from 0 (no pathology) to 6 (high pathology). Global score ranges from 0 to 6. Higher scores indicate greater eating pathology. A reduction in post-treatment scores indicates improvement in eating disorder symptoms.

    Measured: Baseline and Week 12

  2. Change in Beck Depression Inventory-II (BDI-II) scores

    The BDI-II consists of 21 items scored from 0 to 3, yielding a total score between 0 and 63. Higher scores reflect more severe depressive symptoms:

    0-13: minimal 14-19: mild 20-28: moderate 29-63: severe A decrease in BDI-II score post-CBT is expected, reflecting reduced depressive symptoms.

    Measured: Baseline and Week 12

  3. Change in Beck Anxiety Inventory (BAI) scores

    The BAI includes 21 items rated from 0 to 3, with a total score ranging from 0 to 63. Higher scores indicate more severe anxiety:

    0-7: minimal 8-15: mild 16-25: moderate 26-63: severe Post-CBT reductions in BAI scores suggest improved anxiety regulation.

    Measured: Baseline and Week 12

  4. Change in Yale-Brown Obsessive Compulsive Scale - Body Dysmorphic Disorder Version (YBOCS-BDD) scores

    The YBOCS-BDD contains 12 items rated from 0 to 4, yielding a total score range of 0 to 48. Higher scores reflect greater severity of body image-related obsessions and compulsions. Scores ≥ 20 are considered moderate to severe. Post-treatment reductions reflect decreased symptom severity.

    Measured: Baseline and Week 12

  5. Change in Cognitive Emotion Regulation Questionnaire (CERQ) scores

    The CERQ includes 36 items rated from 1 (almost never) to 5 (almost always), across 9 subscales (e.g., catastrophizing, reappraisal, rumination). Subscale scores range from 4 to 20. Higher scores in adaptive subscales and lower scores in maladaptive subscales post-CBT indicate improved emotional coping. The CERQ includes 36 items rated from 1 (almost never) to 5 (almost always), across 9 subscales (e.g., catastrophizing, reappraisal, rumination). Subscale scores range from 4 to 20. Higher scores in adaptive subscales and lower scores in maladaptive subscales post-CBT indicate improved emotional coping.

    Measured: Baseline and Week 12

  6. Change in subjective distress ratings on Visual Analog Scale (VAS)

    The VAS is a self-reported 0-10 scale used to assess momentary emotional distress following exposure to visual stimuli.

    0 = no distress 10 = extreme distress Lower VAS scores after CBT indicate increased emotional tolerance of body and food-related images.

    Measured: Immediately after the experimental task at both baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2025
  2. Study start15 May 2025
  3. Primary completion15 Sep 2025 (estimated)
  4. Study completion15 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A two-arm, parallel-group, randomized controlled trial comparing the effects of a 12-week Cognitive-Behavioral Therapy program versus a waitlist control in individuals with restrictive-type anorexia nervosa. Participants undergo neurophysiological (EEG), physiological (GSR), and attentional (eye-tracking) assessments before and after the intervention.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07037017
Sponsor's protocol ID
AN-CBT-EEG-2025
Status last verified
Jun 2025
First submitted
17 Jun 2025
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 41892652

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive-Behavioral Therapy in people with Eating Disorders (Excluding Anorexia Nervosa), run by Istanbul Nisantasi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Metin Çınaroğlu, Phd (00905324732070, metincinaroglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in EEG P300 amplitude in response to body image stimuli (time frame: aseline and Week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07037017, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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