Clinical Research Directory

Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents: a Randomized Controlled Trial With Long-term Follow-up

The main purpose is to investigate the effectiveness of a 10-week multicomponent camp intervention to reduce BE behavior in children and adolescents and explore in a randomized controlled setting if a parent-based BED-intervention has any add-on effect, attenuating the development of BE behavior in this sample. The study will include an initial follow-up assessment scheduled 10-12 weeks after camp completion and plans for long-term follow-up assessments one, three and five years after inclusion. Overall, we hypothesize that the multicomponent camp intervention will effectively reduce BE behavior in children and adolescents. Furthermore, we hypothesize that participants whose parents are randomized to receive the parental BED intervention will show a lower prevalence of BE behavior one year after the camp intervention compared with children whose parents receive standard care.

COR Protocol for the Treatment of Binge Eating in Chilean Adults (COR)

The goal of this clinical study is to learn whether a brief online psychological program called COR can be delivered in a feasible and acceptable way for adults who experience recurrent binge eating. The main questions this study aims to answer are: * Is the COR program acceptable to participants, in terms of satisfaction, adherence, and dropout rates? * Is the COR program feasible to deliver online, including recruitment, retention, and completion of sessions and questionnaires? * Do participants show preliminary changes over time in binge eating-related distress and emotional well-being? Participants in this study are adults who experience recurrent episodes of binge eating. They will take part in an individual online intervention that includes eight weekly sessions, a brief pre-session, and a follow-up session one month after the end of treatment. During the study, participants will: * Attend weekly online sessions focused on understanding binge eating, emotions, and the relationship with food and the body * Practice simple exercises to help manage emotional distress and food-related urges * Complete short questionnaires before, during, and after the intervention to describe their experiences The information from this study will help researchers understand whether this type of intervention can be used in future, larger studies and in real-world clinical settings.

Video-based Guided Self Help Dialectical Behavior Therapy for Binge Eating Disorder

Dialectical Behavior Therapy (DBT) is an effective treatment for eating disorders, showing promising remission rates for Binge Eating Disorder (BED) in both standard and guided self-help formats. Traditional guided self-help models typically combine weekly chapter readings with a limited number of brief therapist meetings. However, the requirement of weekly book readings can be particularly challenging for individuals with BED, who often exhibit impulsive personality traits, psychiatric comorbidities, and weight-related health problems. This study was developed to test a version of guided self-help DBT-BED delivered through video lessons instead of text. This randomized clinical trial will be conducted at the Eating Disorders Program of the Institute of Psychiatry, Hospital das Clínicas, Faculty of Medicine, University of São Paulo (AMBULIM IPq HC FMUSP), Brazil. Eighty adults with BED will be randomized to either an experimental group (weekly video lessons) or a control group (weekly text-based readings). Both groups will undergo a 13-week intervention, including six brief 30-minute online guidance sessions with a psychologist. The primary outcome will be full remission from binge eating episodes at the end of treatment and at the 3-month follow-up. Secondary outcomes will include changes in eating disorder psychopathology, emotion regulation, quality of life, self-esteem, and dropout rates. Statistical analyses will follow the intention-to-treat principle.

Sleep and Activity For Eating Disorders

The SAFE (i.e., Sleep and Activity For Eating disorders) study aims to investigate the characteristics of sleep, daytime activity, and circadian rhythms in a sample of patients with eating disorders-specifically anorexia nervosa, bulimia nervosa, and binge-eating disorder-as well as the relationship between these variables and physiological parameters (i.e., body mass index, hormone levels, blood chemistry parameters) and psychological parameters (i.e., levels of depression and anxiety, body image, eating-disorder symptoms).

Combining Digital Cognitive-behavior Therapy With Mindfulness Training for Binge Eating Disorder

The investigators will evaluate the acceptability and feasibility of a 16-session digital mindfulness-based and cognitive behavioral therapy (CBT) intervention for binge eating disorder (BED) + coached self-monitoring vs. a coached self-monitoring intervention. This study is a pilot randomized controlled trial.

Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder

The purpose of this study is to assess the efficacy and safety of tirzepatide in adults with obesity and binge-eating disorder, comparing tirzepatide against placebo and lisdexamfetamine dimesylate. All participants will receive guided self-help cognitive behavioral therapy.

Behavioral Therapy and GLP-1 Analogue Effects on Binge Eating, Weight, and Coping in Obesity

This study is a clinical, longitudinal, non-randomized, prospective observational study that seeks to compare the treatment effects and safety of using GLP-1 analogues versus not using appetite suppressants during a lifestyle treatment program that includes individual consultations every fourth month and 10 weeks of CBT-E group therapy in patients with both obesity and BED. The primary objective of this study is to evaluate the impact on BED symptomatology, while the secondary objectives include examining the potential adoption of alternative harmful coping mechanisms. Additionally, the study will assess psychological well-being and weight changes and their consequent influence on obesity-associated comorbid conditions. Adult patients with coexisting obesity and BED presenting at the Obesity clinic at Haukeland University Hospital, Bergen, Norway, will be included Patients will be divided into two groups: Group-GLP1 (n = 40), who will use GLP-1 analogues, and Group-NoMED (n = 40), who will not use appetite suppressants. Both groups will otherwise follow the routine standardized patient care pathway with follow-up controls every four months and participation in CBT group therapy sessions. Changes in symptoms of BED, alternative harmful coping strategies and mental health will be recorded at baseline and 12 months using patient-reported questionnaires, as well as anthropometric and biochemical data.

Disordered Eating Risk in Pediatric Obesity Treatment Using a Digi-Physical Tool

The goal of this observational study is to evaluate the risk of developing disordered eating behavior or an eating disorder among children and adolescents with obesity who have used a digi-physical treatment tool with daily measurements conducted at home. The primary outcomes are to: * Evaluate the proportion of patients exhibiting documented signs of disordered eating behaviors during or after treatment (e.g., caloric restriction, skipping meals, binge eating). * Evaluate the proportion of patients diagnosed with an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder) during or after treatment. Patients at Martina Childrens Hospital, Stockholm, Sweden, who have been treated with the digi-physical treatment tool will be included and their patient records will be reviewed for eating disorder diagnosis or a disturbed eating behavior.

Investigation of the Mechanisms of the Gut-brain Axis in Binge Eating and Obesity.

Binge Eating Disorder (BED) is a recently recognized eating disorder, characterized by recurrent episodes of overeating with a loss of control. Highly comorbid with obesity, BED is associated with poor outcomes in weight loss treatments and presents unique challenges due to its distinct neuro-psycho-biological mechanisms, which remain poorly understood. The Microbiota-Gut-Brain Axis (MGBA) is a bidirectional communication system linking the gut microbiota with the central nervous system, that plays a critical role in regulating appetite, mood, and eating behavior. Dysregulations in MGBA may contribute to the development and maintenance of BED, offering a novel framework for understanding its complex mechanisms and identifying new therapeutic targets. Psychobiotics -pre-, pro-, or symbiotics that modulate the microbiota- emerge as a promising treatment strategy to address BED symptoms by influencing MGBA activity. The goal of this randomized clinical trial (RCT) is to investigate the role of psychobiotics in modulating the gut-brain axis and improving binge eating in adults, with a particular focus on evaluating these effects independently of obesity status. This project stands out for its comprehensive approach to understanding BED, integrating psychological, neurofunctional, hormonal, and microbiota factors that contribute to this complex disorder. The main questions it aims to answer are: * What specific alterations in the MGBA pathways are associated with BED? * Can psychobiotic supplementation effectively reverse microbiota alterations and modulate MGBA activity, ultimately improving BED symptoms? Researchers will compare participants receiving psychobiotics to those receiving a look-alike substance that contains no drug (a placebo) to evaluate whether psychobiotics impact endocrine hormones, neurofunction, psychological and behavioral factors related to eating regulation, and BED symptoms. Participants will: * Undergo an assessment protocol that includes microbiota sampling, blood tests for hormone analysis, neurofunctional evaluations, and psychological/behavioral assessments before and after the psychobiotics/ placebo intervention. * Take psychobiotics or a placebo daily for 12 weeks and receive well-being monitoring * Participate in follow-up visits three months after the intervention to monitor changes in BED symptoms and related parameters.

Effectiveness of Group EFT for Transdiagnostic Eating Disorders/Difficulties Within Student Counselling Services.

What is the purpose of the study? Emotion-Focused Therapy (EFT) is a therapeutic approach that helps individuals identify, explore, and transform difficult emotions to improve emotional wellbeing and resolve psychological issues. While there is a growing body of evidence for the effectiveness of both individual and group EFT with a range of difficulties, including eating disorders, this has not yet been sufficiently explored within university counselling services. The purpose of this study is to assess the feasibility, acceptability, and preliminary effectiveness of a group EFT intervention for students experiencing eating disorders or concerns related to eating, weight, and shape. The study aims to determine whether this type of therapy can be effectively delivered within a university counselling service, and if it could potentially improve participants' mental health and wellbeing.

A Self-Guided Mobile Intervention for Adults With Binge Eating and Obesity

The proposed study is an open label, non randomized, waitlist controlled single group feasibility study of the feasibility and usability of a digital intervention (called ChangeBite) to be used by individuals with obesity and comorbid binge eating behavior. The proposed research will include approximately 30 participants. Participants will be recruited for this single group pilot trial using online advertising to attend a virtual screening session. Screened participants willing and eligible to participate, will receive informed consent and formally start ChangeBite. Participants will be instructed to engage with ChangeBite and attend follow up assessments on scheduled video calls. Feasibility and acceptability of implementation will be assessed by collecting data on recruitment, retention, usability and satisfaction. The research team will also collect assessment data from participants on feasibility, and usability. In addition to self report scales, semi-structured interviews will be completed with a trained research team member via video call and will be partially recorded. Assessments will be done at baseline, 12 weeks, and 24 weeks. Participants' app use frequency and duration will be tracked using software analytics. Participants' body weight will be captured weekly using a timestamped picture of their weight as it appears on their scale and Body Mass Index will be calculated with these data points.

A Longitudinal Study of Severe and Enduring Eating Disorders

The goal of this observational longitudinal study is to investigate characteristics and factors associated with the development of Severe and Enduring Eating Disorders (SEED). In this project, the researchers will follow two prospective cohorts of patients with eating disorders (ED), one adolescent (ages 14-17) and one adult (ages 18+), in terms of change in and impact of clinical, psychological, and biological risk factors. Data will be collected at baseline, after treatment, two years after baseline, and thereafter five, 10 and 20 years after baseline. Participants will be asked to undergo a physical examination, leave blood samples, be interviewed, and fill in questionnaires. If the participants are minors, their care takers will also fill in the questionnaires. The study aims to explore how clinical, psychological, and biological risk factors-including comorbidity, personality characteristics, difficulties with emotion regulation (ER), cognitive inflexibility, loneliness, severe ED symptoms, and inflammatory activation-contribute to a chronic course of the disorder.