Loading clinical trials...
Loading clinical trials...
Showing 1-20 of 132 trials
NCT06171711
The current proposal will evaluate the feasibility, acceptability, and preliminary efficacy of Exposure Therapy for anorexia nervosa (AN) spectrum disorders (Exp-AN), an innovative treatment rooted in principles of inhibitory learning. Exp-AN will target anxiety about both eating and weight gain by combining in vivo (i.e., in real life) and imaginal (i.e., mental) exposure in novel ways (e.g., eating a feared food while listening to a recording describing fears about weight gain).
NCT05873127
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.
NCT07534059
Eating disorders (EDs), as classified by the American Psychiatric Association's DSM-5, have an estimated lifetime prevalence of 0.6% in the Caucasian adult population, with a male-to-female ratio of 1:8, and begin in 84% to 87% of cases between the ages of 15 and 25. Anorexia nervosa (AN) is an eating disorder that represents a significant public health concern due to its impact on long-term morbidity and mortality. The incidence of AN is steadily increasing in many countries, particularly in France, with a prevalence of 2-3% among adolescents and young adults. A 10-year mortality rate of 5-10% has been reported, making AN the psychiatric disorder with the highest mortality rate. This predominantly female disorder (female-to-female ratio of 1:9) is defined by the persistent association of disordered eating behavior, distorted body image, and obsessions with weight and food, with detrimental health consequences. Anorexia nervosa (AN) exposes patients to numerous somatic and neuropsychiatric complications, which are poor prognostic factors. Its etiopathogenesis is multifactorial and involves environmental, psychological, genetic, and sociocultural factors. Bulimia nervosa (BN) is also associated with an intense fear of gaining weight. There is a disturbance of body image characterized by profound dissatisfaction with weight and physical appearance. BN is characterized by binge-eating episodes (consuming a large amount of food in a short period of time, associated with a feeling of loss of control) followed by inappropriate compensatory behaviors such as self-induced vomiting, misuse of laxatives, diuretics, or other medications; fasting; and excessive exercise. Individuals with bulimia nervosa generally have a subnormal body mass index (BMI), making diagnosis more difficult. Type 1 diabetes is an autoimmune disease characterized by the destruction of the beta cells of the pancreatic islets of Langerhans, leading to a deficiency in insulin secretion. Generally, the diagnosis is made in childhood or adolescence, but late-diagnosed forms exist, forming an entity called latent autoimmune diabetes in adults (LADA), also known as type 1 diabetes. Diagnosis is made by measuring antibodies specific to type 1 diabetes: anti-GAD and anti-IA2 antibodies as the first-line tests, and anti-ZnT8 antibodies as a second-line test. Drug treatment primarily relies on continuous insulin administration via multiple daily injections or an insulin pump. Nutritional management is a cornerstone of treatment, playing a crucial role in glycemic control and the prevention of metabolic complications. "Diabulimia" is a recent term describing a specific eating disorder in patients with type 1 diabetes. It is characterized by a voluntary restriction of insulin administration for the purpose of weight loss, at the expense of optimal glycemic control. This condition involves several complex factors (such as insulin injection, capillary blood glucose, emotions, and body image) that link diabetes management to the patient's mental health. "Diabulimia" is not yet recognized as a distinct medical entity, lacks precise diagnostic criteria, and is difficult to detect. However, the serious consequences it entails, such as diabetic ketoacidosis in the short term and the chronic complications of hyperglycemia in the long term, make its screening essential.
NCT05382702
The proposed study tests fear, gut peptide response, and perceptions of fullness as causes of gastrointestinal distress and eating disorder maintenance.
NCT07516431
This pilot interventional study aims to evaluate the usability and preliminary effects of a structured plate designed to support eating behaviors in children with Autism Spectrum Disorder (ASD), as well as its perceived psychosocial impact on their families. Feeding difficulties are common in children with ASD and may include food selectivity, behavioral challenges during mealtimes, and family stress. In this single-group pre-post study, children aged 5 to 7 years with ASD and significant feeding difficulties will use the structured plate during school lunchtime three times per week for two months under the supervision of an occupational therapist. Outcomes will assess changes in feeding behaviors and mealtime functioning, as well as caregiver-reported psychosocial impact. Assessments will be conducted at baseline and after the intervention. Findings from this pilot study will inform the feasibility and design of future larger-scale controlled studies.
NCT07518641
Moving from pediatric (children's) health care to adult health care can be challenging for youth and young adults with eating disorders. Many young people and families report feeling unprepared, unsure of what to expect, and worried about losing support during this time. Gaps in care during this transition can increase stress and make recovery more difficult. This study is testing a structured transition support program called the TransitionED framework. The goal is to see whether this program can be successfully used in real hospital settings and whether youth, caregivers, and clinicians find it helpful. The TransitionED framework is designed to help youth and families prepare for the move to adult care. It includes: 1. A transition planning package for youth 2. A separate planning package for caregivers 3. At least two guided transition meetings with a clinician 4. A short "Personal Transition Profile" written by the youth to help new adult providers understand them better 5. Optional virtual peer support sessions for youth and for caregivers 6. Tools to help pediatric and adult providers communicate more clearly Youth who are 16 years or older and currently receiving care in a participating pediatric eating disorder program may be invited to join, along with one caregiver. Clinicians and program leaders will also take part to help deliver and evaluate the program. Participants will complete surveys at the beginning of the study, about two months later, and six months after finishing the program. Some participants will also take part in interviews to share their experiences. This study is focused on feasibility. That means the main goal is to learn whether this transition program is practical, acceptable, and workable in everyday clinical care. What we learn will help improve transition support for youth and young adults with eating disorders in the future.
NCT06800807
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.
NCT05543044
Participants will be males and females aged 16-24 with an eating disorder (ED) diagnosis who are transitioning to adult-oriented ED treatment in Nova Scotia, New Brunswick, or Prince Edward Island. Youth participants will be recruited from community-based clinics, hospital programs, and private practices where ED treatment is delivered. Youth who are interested in participating and provide written consent will be invited to take part in a screening meeting to determine eligibility to participate. Eligible participants will be paired with a peer mentor for a 3-6 month intervention to guide them through the transition to adult-oriented ED treatment. Participants will be asked to complete questionnaire packages before beginning the intervention, after completing the intervention, and 12 months after beginning the intervention. Some youth participants, as well as some of their carers and the peer mentors, will be asked to participate in one-on-one interviews about their experiences with transitions in ED care and the peer mentor intervention. The investigators are conducting this study to determine whether the use of peer mentors is an effective and acceptable means of transition support for youth with EDs. The investigators are also interested in better understanding the experiences of carers and peer mentors who are supporting youth with EDs during their transition in care.
NCT07452393
This is a multicenter, observational, cross-sectional study of young people aged 10 to 25 with type 1 diabetes in Spain, affiliated with a diabetes association or federation. Data will be collected through an online questionnaire in which participants voluntarily and anonymously self-report their responses. The study aims to assess psychological factors (psychological distress, risk of eating disorders, and self-perceived health status), health care behaviors (treatment adherence, diet, and physical activity), and sociodemographic data, exploring differences by age and sex and examining associations between variables.
NCT05712057
The primary goal of this clinical trial is to evaluate the unique neural and behavioral effects of a one-session training combining emotion regulation skills training, with excitatory repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC). The secondary aim is to identify key changes in the emotion regulation neural network following the combined intervention versus each of the components alone. The third aim is to explore personalized biomarkers for response to emotion regulation training. Participants will undergo brain imaging while engaging in an emotional regulation task. Participants will be randomly assigned to learn one of two emotion regulation skills. Participants will be reminded of recent stressors and will undergo different types of neurostimulation, targeted using fMRI (functional MRI) results. Participants who may practice their emotion regulation skills during neurostimulation in a one-time session. Following this training, participants will undergo another fMRI and an exit interview to assess for immediate neural and behavioral changes. Measures of emotion regulation will be assessed at a one week and a one month follow up visit.
NCT05540704
The goal of this clinical trial is to test whether a new intervention works to treat eating disorders in type 1 diabetes. Participants are assigned to one of the following: (1) Acceptance and Commitment Therapy (ACT), (2) Supportive Diabetes Counseling, or (3) a 6-month Waitlist Control. Participants in the ACT and Supportive Diabetes Counseling conditions complete 12 sessions over 12-16 weeks and use their mobile phone between sessions to increase engagement and reinforce learning. The main questions are: Does treatment improve glycemic levels, eating disorder symptoms, diabetes management and diabetes distress? Does one treatment do better than the other? How do the treatments work, if they work, and for whom? Participants complete assessments that include wearing a continuous glucose sensor and activity watch, and get a blood draw to determine HbA1c. They also complete diagnostic interviews, surveys and computer tests of attention and things like heart rate and reaction time. These assessments help us better understand the types of changes that are happening and how they might influence health and well-being.
NCT07434557
Obesity represents an increasingly serious public health problem worldwide. According to the World Health Organization, one in eight individuals globally is affected by obesity. Bariatric surgery (BS) is recognized as the most effective treatment for severe obesity and has been shown to significantly improve obesity-related comorbidities. However, despite initially successful surgical outcomes, a substantial proportion of patients experience insufficient weight loss (IWL) or weight regain (WR) after surgery. Previous studies have identified multiple factors associated with post-bariatric IWL and WR, including older age, low socioeconomic status, higher baseline body mass index (particularly preoperative BMI \>50 kg/m²), type of surgical procedure, hormonal mechanisms, poor adherence to postoperative dietary recommendations, maladaptive eating behaviors, insufficient physical activity, and the presence of psychiatric comorbidities. Among these, behavioral factors appear to play a particularly critical role. Irregular eating patterns such as loss of control eating, maladaptive behaviors such as grazing, non-adherence to dietary guidelines, and a return to preoperative eating habits are frequently associated with weight regain. Additionally, physiological mechanisms, including increased appetite, food cravings, and altered hormonal regulation of energy intake, may further contribute to this process. Grazing behavior-defined as repetitive consumption of small amounts of food accompanied by a sense of loss of control-has been consistently associated with poorer weight outcomes after bariatric surgery. A large meta-analysis reported grazing prevalence rates between 16.6% and 46.6%, with weight regain observed in nearly half of post-bariatric patients. Moreover, lack of structured nutritional follow-up has been shown to significantly increase the risk of weight regain. Neurobehavioral changes also occur after surgery: while appetite and responsiveness to palatable foods typically decrease during the first postoperative year, these effects often diminish over time, with hunger, cravings, and portion sizes gradually increasing in some individuals. Long-term weight regain has been closely linked to disordered eating behaviors, including emotional eating, binge eating, compulsive eating, food addiction, and loss of control eating. Recent studies have demonstrated significant associations between weight regain and binge eating disorder, eating disinhibition, and impulsivity. Qualitative research further highlights that many patients struggle to manage emotional eating and require ongoing psychological and dietary support following surgery. Despite growing evidence emphasizing the behavioral and psychological components of post-bariatric outcomes, comprehensive studies that simultaneously evaluate nutritional status, eating disorders, and emotional factors in individuals experiencing IWL or WR remain limited. Therefore, the present study aims to assess nutritional status, eating disorder symptoms, and emotional factors in individuals who experience insufficient weight loss or weight regain after bariatric surgery. By integrating anthropometric, nutritional, behavioral, and emotional assessments within the same sample, this study seeks to provide a multidimensional perspective and contribute to the development of more effective multidisciplinary follow-up and psychodietetic interventions.
NCT07387965
The goal of this clinical trial is to learn if providing eating disorder patients with education about the consequences of cannabis (marijuana) use on mental health, gastrointestinal symptoms, eating disorder symptoms, and eating disorder treatment effectiveness increases their knowledge about the cannabis use consequences, intention to reduce cannabis use, and motivation to seek treatment for their cannabis use. The main questions this study aims to answer are: 1. Does education about consequences of cannabis use increase eating disorder patients' knowledge about the risks of cannabis use? 2. Does education about the consequences of cannabis use increase intention to reduce cannabis use and seek cannabis use treatment among those with eating disorders? 3. Does cannabis use interfere with how successful eating disorder treatment is for eating disorder patients? All participants will receive 20 weeks of eating disorder treatment. In week 1 of treatment, participants will either be assigned to receive education about cannabis use consequences, or be assigned to a control condition where they receive education about consequences of poor sleep. Participants will be asked to complete a number of questionnaires that measure knowledge about cannabis use consequences, intention to reduce use and seek cannabis use treatment, eating disorder symptoms, and cannabis use habits. Researchers will assess how effective providing education about cannabis use consequences is on changing knowledge about cannabis use risks, intention to reduce use, and intention to seek cannabis use treatment. It will also be examined if effectiveness of eating disorder treatment is related to cannabis use habits.
NCT04174703
Compassion-focused therapy (CFT) seeks to lower shame and help people develop compassion for personal distress and shortcomings. There is increasing evidence to support the benefits of incorporating CFT-based interventions into the treatment of eating disorders (EDs). Building on the investigators' prior research, this study will examine the effects of a two-week CFT-based self-compassion letter-writing intervention on patients with eating disorders. Participants will be recruited from the wait-list of patients scheduled to begin treatment at the outpatient St. Joseph's Healthcare Hamilton Eating Disorders Program, and will be randomly assigned to the two-week letter-writing intervention or to a control group. Results will inform the integration of new empirically-derived interventions into ED treatments to improve the currently dismal rates of ED recovery.
NCT07060534
Eating disorders (EDs) are a critical concern on college campuses. Moreover, since the COVID-19 pandemic, ED prevalence has increased by 62% in university women and 140% in university men. Resources are inadequate to meet demand, leading to delays in students' access to treatment. Untreated (or poorly treated) EDs result in greater healthcare utilization and costs to students, as well as lower academic achievement and increased psychiatric disability and mortality, suggesting a critical need for quality ED treatment on university campuses and to rethink treatment delivery. One way to address this gap in care delivery is to improve treatment accessibility and scalability, such as dissemination via mobile apps. Guided self-help Cognitive Behavior Therapy (CBT-gsh) is a cost-effective option that can be delivered by non-traditional service providers, such as nurses and physicians. Our scientific premise is that the mHealth CBT-gsh app, Building Healthy Eating and Self-Esteem Together for University Students (BEST-U), will lead to reductions in binge eating (primary outcome) through reductions in dietary restraint and weight/shape concerns (target mechanisms). Prior to implementing BEST-U at other universities, we need to test the intervention in a real-world setting with the end goal of disseminating at scale. Our objectives are to: 1) conduct an effectiveness test of BEST-U compared to a similar dose of present-centered therapy (PCT) in students with non-low weight binge-spectrum EDs and 2) test target mechanisms that lead to changes in binge eating. To accomplish our objectives, we will test the following specific aims: 1) conduct an RCT of BEST-U (N=37) compared to a similar dose of PCT (N=37) in students with non-low weight binge-spectrum EDs; 2) test target mechanisms that lead to changes in binge eating and other ED symptoms; and 3) characterize barriers and facilitators to implementation across two campuses. Our exploratory aim will test food reinforcement and food-choice impulsivity as potential target mechanisms or response moderators of rapid response in binge eating. Given that few studies have identified underlying mechanisms that explain how CBT-gsh works and for whom, this study may lead to improved ability to tailor or modify existing CBT-gsh or lead to novel intervention development for students who are unlikely to respond rapidly (or at all) to first line CBT interventions for EDs.
NCT05885971
Eating disorders (ED) are insufficiently detected and belatedly or not treated during pregnancy. There are many screening questionnaires for eating disorders in the literature, but we note the absence of a specific and validated tool for their screening during pregnancy, which would make it possible to differentiate maternal dietary concerns related to pregnancy from symptoms linked to a proven eating disorder. The main objective of the study is to evaluate which items of the Sick Control One stone Fat Food (SCOFF-F) and Eating disorders examination questionnaire (EDE-Q) questionnaires could be specific to an ED during pregnancy and not related to the simple state of pregnancy, by comparing the answers of pregnant women, for whom the diagnosis of ED has been made, to those of pregnant women without an ED.
NCT07319936
It is often difficult for people with eating disorders to get timely access to specialized treatment, as waitlists can be long. The present study examines whether or not providing educational materials by email could help individuals with eating disorders while they wait for specialized care. The investigators hypothesize that a low-intensity self-guided intervention will lead to a reduction in eating-disorder attitudes and cognitions, and an increase in motivation to change and body satisfaction. Sixty-two adults (primarily women) are randomly assigned to one of two groups while being on the waitlist for specialized eating-disorder services. One group receives weekly emails for four weeks with psychoeducational materials about eating disorders; the other group does not receive any materials. The content was adapted from a validated eating-disorder workbook developed by the Centre for Clinical Interventions in Australia and translated into French. Each week, as well as one week after the intervention period, all participants complete brief questionnaires assessing eating-disorder thoughts, body satisfaction, and readiness to make changes in eating behaviours. Participants who receive the materials also rate their level of satisfaction with the materials as well as how useful and engaging they find the content.
NCT06256380
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.
NCT06306586
The goal of this feasibility study is to evaluate the feasibility and preliminary clinical outcomes of a personalized digital treatment for adolescents with eating disorders. The main objectives are to: i) Evaluate whether a personalized digital treatment for adolescents with eating disorders are feasible in a child and adolescent psychiatric outpatient clinic. ii) Evaluate who benefits from a personalized digital treatment for adolescents with eating disorders (what works for whom?) iii) Evaluate the cost-benefit of a personalized digital treatment for adolescents with eating disorders. Participants will be enrolled in a 10-week digital treatment including weekly therapist contact. They will be asked to complete self-report questionnaires at pre-, during, post- and 3- and 6-months follow-up.
NCT07179068
Body image concerns have been linked to diverse mental health issues, including depression and disordered eating. Disordered eating can develop into clinically significant eating disorders, which are associated with serious negative impacts on psychological and physical well-being, and can adversely impact developmental trajectories in children and adolescents. Given limitations in the eating disorder intervention literature, it is important to invest in effective eating disorder prevention programs. Evidence suggests that children can recognize the existence of societal appearance ideals as early as age 3; thus, this study examines the acceptability and feasibility of a single-session, online, parent-focused intervention targeting predictors of body image disturbance in young children.