Clinical Research Directory

Metacognitive Beliefs in Adolescents With Eating and Nutrition Disorders

The present study aims to study the presence of metacognitive beliefs in adolescent subjects with eating and nutrition disorders (END) compared with a control group composed of subjects of the same sex and age belonging to the general population.

Artificial Intelligence-based, Virtual Reality Application to Provide Data- Driven, Patient-centred Treatment for People With Eating Disorders

The goal of this clinical trial is to see if a short virtual reality (VR) program can be used safely and comfortably with people receiving care for anorexia nervosa. The study will also check if people are willing to take part and complete the full week of VR sessions. The main questions the study will answer are: Can the investigators recruit and keep participants in the study? Do participants complete most of the VR sessions? Do they find the experience helpful and acceptable? Are there any side effects, like nausea or dizziness? Participants will: * Take part in one VR session each weekday (about 20 to 30 minutes) for one week * Continue their usual care during this time * Answer questions before and after the VR sessions about their anxiety, mood, motivation, and experience * Some participants may join a short interview or focus group to share feedback The VR program includes scenes for food-related exposure, calming music, motivational phrases, and goal setting. The app was designed with help from people with lived experience of anorexia and based on psychological therapies used in treatment. Who can take part: * Adults aged 18 or older * People receiving or waiting for care for anorexia nervosa at South London and Maudsley NHS Foundation Trust (SLaM) * People who are medically stable and able to give informed consent Why this matters: This study will help researchers understand if using VR in eating disorder services is practical, safe, and acceptable. The results will help plan a larger trial in the future to see if this type of VR treatment can support recovery from anorexia nervosa. Taking part is voluntary, and participants can stop at any time.

The diabEAT Study: Insulin dElivery Technologies And eaTing Behaviours in People With Type 1 Diabetes

Type 1 diabetes is an autoimmune health condition that requires daily injections of insulin. Insulin allows the body to use energy from carbohydrates in food. Disordered eating behaviours, like restricting food intake to lose body weight, are more common in women and people with type 1 diabetes, compared to those without because they must practice carbohydrate counting. Carbohydrate counting means identifying, measuring, and planning carbohydrate intake to match insulin dosage. New technologies, such as automated insulin delivery (AID) systems adjust insulin delivery in a blood sugar responsive manner. AID is rapidly replacing conventional insulin delivery like injections or non-automated insulin pumps since it reduces management burden and improves blood sugar levels. It is not known if AID reduces food management and disordered eating behaviours. This study aims to: 1. investigate the relationship between AID and eating behaviours according to gender for youth (12 to 17 years), and adults (18 years and older). 2. Determine the limit of carbohydrate counting inaccuracy to maintain stable blood sugar levels according to insulin delivery method (AID, injections, or pumps). It is hypothesized that those who use AID will have lower disordered eating behaviours and will maintain stable blood sugar levels while allowing for higher carbohydrate counting inaccuracy. This will be a cross-sectional cohort study of people with type 1 diabetes who are 12 years of age or over. Participants will be recruited through the BETTER registry and social medias across Canada. This research is needed to improve nutrition guidelines for type 1 diabetes in the context of new technologies like AID. Evidence from this study may reduce food management burden, lower the risk of disordered eating behaviours, and prevent eating disorders and medical complications.

Comparing Enhanced Cognitive-behavior Therapy and Family-based Treatment for Adolescents With an Eating Disorder

The goal of this randomized controlled clinical trial is to compare the efficacy of outpatient family-based treatment versus enhanced cognitive behavior therapy for children and adolescents with eating disorders. Because of insufficient recruitment, the study design was modified on December 1st, 2025, to a partially randomized preference design. The main aim is to determine if enhanced cognitive behavior therapy has a similar efficacy as family-based treatment among children and adolescents with eating disorders receiving treatment in an outpatient setting. The main outcome is improvement in eating disorders psychopathology at the end of treatment.

Cognitive Training for Patients With Eating Disorders

Eating disorders are severe mental illnesses, mainly affecting adolescent- and young adult women. The prognoses for eating disorders are relatively poor, and a large part of patients with these illnesses do not benefit from available conventional therapies. After decades of research into the causes of eating disorders, there is now compelling evidence for specific neuropsychological difficulties in patients affected by eating disorders. These neuropsychological difficulties are characterized by cognitive and behavioral rigidity (poor set-shifting abilities), as well as difficulties related to central coherence, planning and impulse control. Surprisingly, few therapies specifically target these difficulties, and they are rarely incorporated into treatment. Cognitive Remediation Therapy has shown promising results as an adjunctive therapeutic intervention for patients with anorexia Nervosa. The primary aim of this randomized controlled trial is thus to investigate the effect of Cognitive Remediation Therapy on neuropsychological function, symptoms of eating disorders and general mental health, quality of life and motor activity in women with both eating disorders (transdiagnostic) and these specific cognitive difficulties.

Web-based Guided Self-help CBT-E vs Online G-CBT-E for Binge Eating Behavior

Eating disorders with binge eating as the core feature include bulimia nervosa (BN) and binge eating disorder (BED). In recent years, the prevalence rate has increased rapidly, mostly among women, accompanied by emotional problems, physiological complications and increased risks of obesity and depression, which bring great pain to patients. Enhanced Cognitive Behavioral therapy (CBT-E) for eating disorders is an evidence-based and effective first-line psychotherapy for BN and BED. CBT-E is implemented in various forms. In addition to face-to-face therapy, online group CBT-E and guided self-help CBT-E can significantly reduce binge eating in BN and BED patients. However, there are no relevant clinical studies in China. Since 2008, the applicant has carried out CBT treatment and research on eating disorders, translated and published the self-help book "Overcoming Overeating", and accumulated rich clinical research experience. This study intends to establish a set of CBT-E self-help therapy courses suitable for Chinese binge eating patients, and conduct a randomized controlled study of web-based guided self-help CBT-E and online group CBT-E to compare the effectiveness of the treatment modalities in the treatment of binge eating and the feasibility of online guided self-help CBT-E and online group CBT-E in the treatment of binge eating.

Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia

Randomized controlled trial of an exposure-based behavioral treatment (CBT) in adults with functional dyspepsia who meet criteria for avoidant/restrictive food intake disorder (ARFID) with weight loss.

Efficacy of Juniver, a Digital Self-help Intervention, on Symptoms of Eating Disorders: A Randomised Controlled Trial

This project aims to assess the efficacy of the Juniver program on symptoms of eating disorders via a randomised controlled trial. The Juniver program is a self-help intervention for eating disorders delivered digitally, through an iPhone app. It features three components: an evidence-based curriculum, interactive tools, and moderated peer support groups. These three components integrate the evidence for (a) Cognitive-Behavioural Therapy (CBT) and Dialectical Behaviour Therapy for eating disorders; (b) Just-in-Time Adaptive Intervention; and (c) peer mentorship as an adjunct intervention for the treatment of eating disorders. The program was developed by the Juniver team made up of people with lived experience with eating disorders and professional experience in digital health, a panel of neuroscientists and experts specialising in eating disorders, and direct research with 500 participants. This trial aims to investigate the impact of the Juniver program on self-reported eating disorder symptoms, as well as on symptoms of depression, anxiety, psychosocial impairment associated with eating disorders, and perceived stress. This will occur via a randomised controlled trial comparing Juniver to a wait-list control condition over a 12-week period, with further evaluation of the effects of Juniver up to 24-weeks.

Mechanisms of Deep Transcranial Magnetic Stimulation in Enhancing Cognitive-Behavioral Therapy for Anorexia Nervosa

The goal of this clinical trial is to learn if dTMS targeting the ACC can be used to rapidly and effectively treat AN. A randomized controlled study design is adopted, in which patients with AN are divided into the CBT+dTMS treatment group and CBT+pseudostimulation group by 1:1 randomization, followed by a 6-week intervention and a half-year follow-up to clarify whether CBT combined with dTMS is superior to single CBT treatment for AN.

Longstanding Eating Disorders and Personality Disorders

Background Eating disorders rank among the ten leading causes of disability among young women, and anorexia nervosa has the highest mortality rate of all mental disorders. Follow-up studies have shown that 20-30 % of patients with eating disorders develop longstanding symptoms, seriously impairing their daily and represents a public health concern. There are very few studies on the course of these patients. Several studies have demonstrated comorbidity between eating disorders and personality disorders. Among patients with eating disorders, the reported frequencies of personality disorders vary from 27% to 77%. Most of the studies are cross-sectional designs, thus unable to catch trends or changes over time. There is a need for prospective longitudinal studies of adult patients using structured diagnostic interviews both for eating disorders and personality disorders. At Modum Bad, a Norwegian psychiatric hospital, the investigators have conducted a follow-up study of patients with longstanding eating disorder 1-, 2- and 5-years after treatment. The aim of the present project is to follow-up the patients additional 17-years after treatment. Objective Investigate the 17-years course and outcome of adult patients with severe and longstanding eating disorders with regard to eating disorder-related symptoms, general symptoms and personality disorders in addition to examining whether personality disorders and sexual abuse in childhood can predict the course and outcome. Method Examining patients 17-years after treatment with standardized interviews and questionnaires.

Evaluation of Radically Open Dialectical Behavior Therapy for Youth At Risk for Developing Severe and Enduring Eating Disorders

The goal of this experimental interventional study is to learn if the psychological treatment Radically Open Dialectical Behavior Therapy (RO-DBT), is feasible to conduct and provide positive effects for adolescents with eating disorders and emotional overcontrol. Participants will be those at risk for developing severe and enduring eating disorder symptoms, as they have not responded fully to previous treatment attempts. Primary outcomes are feasibility and changes in eating disorder symptoms. Secondary outcomes are changes in unhelpful behaviors and experiences related to emotional overcontrol; including psychological inflexibility, suppression of emotions, and experience of loneliness. The participants will undergo the treatment with RO-DBT, which include an approximately 22 week long treatment consisting of individual psychotherapy and parallel skills training in group.

Fear, Gastrointestinal Distress, and Interoception: Physiological and Psychological Mechanisms in Eating Disorders

The proposed study tests fear, gut peptide response, and perceptions of fullness as causes of gastrointestinal distress and eating disorder maintenance.

Improving Gastrointestinal Function In High-Risk Newborns By Stimulation Of The Enteric Nervous System

The goal of this therapeutical intervention trial is to investigate whether tactile-kinesthaetic and oral sensorimotor stimulation can improve gastrointestional function in preterm infants born before gestational age of 30 weeks and newborns with congenital diaphragmatic hernia. The main question it aims to answer is: • To determine whether HAPTOS- intervention (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation) in the particpants results in earlier attainment (postnatal days) of full enteral feeding and/or full oral feeding (post menstrual age) compared to standard care. Researchers will compare an intervention group receiving standard of care plus HAPTOS intervention to a group of patients receiving only current standard of care.

Italian Validation of the State Urge to be Physically Active- Questionnaire (SUPAQ-I) in Patients With Eating Disorders

Eating disorders (EDs) are severe psychiatric conditions that cause significant health and psychosocial issues, with Anorexia Nervosa (AN) and Bulimia Nervosa (BN) having the highest mortality rates. The COVID-19 pandemic has led to an increase in ED cases, especially among children, with heightened restrictive eating and compulsive exercise. Up to 80% of individuals with AN engage in compulsive exercise, which current treatments fail to adequately address. The State Urge to be Physically Active Questionnaire (SUPA-Q) is the only validated tool for assessing activity urges in ED patients, covering cognitive, emotional, and behavioral aspects. This study aims to develop and validate an Italian version of the SUPA-Q (SUPAQ-I) in a clinical sample of ED patients. A mixed-longitudinal study design will be used, with assessments at admission (T0) and discharge (T1) to evaluate the SUPAQ-I's reliability, validity, and sensitivity to change. The sample will include patients aged 16-65 diagnosed with EDs undergoing inpatient rehabilitation. Statistical analyses will include exploratory and confirmatory factor analyses, and internal consistency will be measured using Cronbach's α and McDonald's Ω indices. Validating the SUPAQ-I will improve the assessment of activity urges in ED patients, enhancing treatment strategies and outcomes.

A New Neuroregulatory Technology for the Therapy of AN Based on the Pathological Neural Network of ACC

Hypothesis of "AN-ACC pathological network" suggests that ACC overactivation and abnormal functional connectivity with other brain regions is the neuropathological mechanism for the onset of AN. Currently, rare studies have been conducted on dTMS targeting ACC as an intervention in patients with AN. In this research, dTMS, a neuroregulatory technology, is used for the first time to intervene with ACC in the treatment of adult AN. A randomized controlled study design is adopted, in which patients with AN are divided into the dTMS treatment group and the pseudo-stimulation group by 1:1 randomization, followed by 6-week intervention and half-year follow up, to clarify the near-term and long-term efficacy and safety of the dTMS treatment. Meanwhile, baseline fMRI data will be extracted and combined with clinical features to establish an efficacy prediction model, which will provide theoretical and practical basis for the pioneering ACC-targeted dTMS treatment in China, helping to establish a new type of intervention program for AN, with expected results of innovation.