CBT Effects on Neural, Physiological, and Attentional Responses in Anorexia Nervosa (NCT07037017) | Clinical Trial Compass
RecruitingNot Applicable
CBT Effects on Neural, Physiological, and Attentional Responses in Anorexia Nervosa
Turkey (Türkiye)60 participantsStarted 2025-05-15
Plain-language 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.
Who can participate
Age range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in EEG P300 amplitude in response to body image stimuli
Timeframe: aseline and Week 12
2
Change in Late Positive Potential (LPP) amplitude to body and food stimuli
Timeframe: Baseline and Week 12
3
Change in frontal alpha asymmetry during self-image viewing
Timeframe: Baseline and Week 12
4
Change in skin conductance response (SCR) to body and food stimuli
Timeframe: Baseline and Week 12
5
Change in fixation duration on weight-related body areas
Timeframe: Baseline and Week 12 Baseline and Week 12