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Bulimia clinical trials

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NCT ID: NCT06431854 Recruiting - Anorexia Nervosa Clinical Trials

Evaluation of a New Treatment Program for Adolescents With Eating Disorders: MINERVA Program

Start date: October 23, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the efficacy, efficiency, and patient experience of a new intervention program on adolescents with high-complexity eating disorders (ED). A prospective group of adolescents with ED (N=60) will follow this treatment program including four different phases: 1) Inpatient treatment; 2) Family Treatment Apartment; 3) Home Treatment; 4) Recovery within the community. The investigators will use a retrospective, control group (N=60) that matched the prospective group in age, sex, ED diagnosis, and severe symptomatology. Primary variables regarding Body Mass Index (BMI), ED symptomatology, functionality, recovery (yes/no), type of outpatient services (low/mid/high intensity), number of readmissions, and patient experience will be assessed at discharge, and after 6 and 12 months. Secondary variables include anxiety, depression, readiness to recover, quality of life symptoms, caregiver skills, and functionality of the family

NCT ID: NCT06413433 Recruiting - Clinical trials for Binge-Eating Disorder

Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol

ENGAGE
Start date: April 26, 2024
Phase: Phase 3
Study type: Interventional

ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder (BED) in adults.

NCT ID: NCT06387719 Recruiting - Obesity Clinical Trials

Precursors of Binge Eating Disorder in a Clinical Sample of Adolescents With Obesity

PREC-BED
Start date: July 21, 2023
Phase:
Study type: Observational [Patient Registry]

BACKGROUND: Binge eating disorder (BED) is the worldwide most-prevalent eating disorder. It is associated with psychiatric comorbidities and obesity, a high impact in life functioning, and high morbidity and mortality. First symptoms appear frequently in youths, who most commonly present incomplete (subthreshold) criteria for BED (precursor forms, PREC-BED). While some subjects will evolve from PREC-BED to BED, there is no gold standard to identify the clinical evolution. Information from prior studies suggest early alterations in reward and inhibitory brain circuits in PREC-BED may predict increased vulnerability or resilience to develop BED. Tools based on MRI brain connectivity analyses (MRI-BC), built on robust and interpretable connectivity whole-brain models, have proven successful in diagnostic classification and predicting certain clinical outcomes. OBJECTIVES: To study MRI-BC diagnostic markers of PREC-BED and to explore prognosis at 1 year of follow-up in a sample of adolescents with obesity (12-17 years old). METHODS: A) Transversal analytical design: 3-group (n=34 per group) comparison of neuroimaging (MRI-BC), neurocognitive and clinical markers in adolescents with obesity and i) BED, ii) PREC-BED, iii) no BED nor PREC-BED (Healthy group, HC). B) Longitudinal analytical design, pilot, exploratory: adolescents with PREC-BED will be evaluated in clinical and neurocognitive variables at 1 year. Baseline brain neuroimaging variables (alone and in combination with clinical and neurocognitive variables) will be analyzed as predictors of clinical prognosis, including conversion to BED.

NCT ID: NCT06349460 Recruiting - Obesity Clinical Trials

A Micro-Randomized Trial to Optimize Just-in-Time Adaptive Intervention for Binge Eating & Weight-related Behaviors

Start date: March 21, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to conduct a micro-randomized trial to learn which evidence-based targets within a mobile intervention for binge eating and weight-related behaviors are most impactful for which people and in what sequence.

NCT ID: NCT06348251 Recruiting - Type 2 Diabetes Clinical Trials

FoodSteps for Binge Eating & Food Insecurity

Start date: March 26, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to conduct a pilot trial of a mobile intervention that targets binge eating and weight-related behaviors, to determine the feasibility, acceptability, and preliminary efficacy of the intervention among adults with recurrent binge eating, diabetes, and food insecurity.

NCT ID: NCT06345040 Recruiting - Anorexia Nervosa Clinical Trials

The Dialogue Study: A Virtual-reality Based Treatment for Eating Disorders

Start date: February 26, 2024
Phase: N/A
Study type: Interventional

The Dialogue Study is a randomized, assessor-blinded parallel-groups superiority clinical trial fulfilling the CONSORT criteria for non-pharmacological treatment. The aim of the trial is to investigate the effect of a new virtual reality based psychotherapy for eating disorders. A total of 96 participants with a diagnosis of anorexia nervosa or bulimia nervosa will be allocated to either Virtual-reality therapy plus treatment as usual or treatment as usual. All participants will be assessed at baseline and 12- and 24 months post baseline. A stratified block-randomisation with concealed randomisation sequence will be conducted. Independent assessors blinded to the treatment will evaluate outcome. Analysis of outcome will be carried out with the intention to treat principles.

NCT ID: NCT06325670 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Type 2 Diabetes and Binge Eating Disorder (BED)

Start date: February 23, 2024
Phase: N/A
Study type: Interventional

The goal of this research project is to improve the treatment of individuals living with both type 2 diabetes (T2D) and Binge Eating Disorder (BED). The research hypothesizes that BED treatment will not only improve BED symptoms but also improve T2D severity and associated cardiovascular risk factors. The research involves a multidisciplinary team, including experts in endocrinology, psychology, and eating disorders. The main questions it aims to answer are: - Does treatment for Binge Eating Disorder lead to improvements in BED symptoms? - Does treatment for Binge Eating Disorder lead to improvements in T2D severity and associated cardiovascular risk factors? Participants will undergo a comprehensive treatment program targeting both BED and T2D. This program will include psychotherapy sessions focusing on cognitive-behavioral techniques to address binge eating behavior. Researchers will compare participants' outcomes before and after the treatment program to assess changes in BED symptoms, T2D severity, and associated cardiovascular risk factors.

NCT ID: NCT06294353 Recruiting - Eating Disorders Clinical Trials

Study of Efficacy and Safety of WELT-ED for Eating Disorder (WCTP-ED-B-01)

Start date: March 29, 2023
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to evaluate the safety and efficacy of a digital therapeutic device (WELT-ED) based on Cognitive Behavioral Therapy (CBT) for the treatment of eating disorders. The main questions it aims to answer are: - Is WELT-ED as effective as standard treatment in reducing the symptoms of eating disorders? - Is the WELT-ED safe for use in the target population without causing adverse effects? Participants will: - Undergo assessments to determine their baseline health status and severity of eating disorder symptoms. - Use WELT-ED or receive standard treatment as directed for the duration of the study period (8 weeks). - Participate in assessments to monitor changes in their eating disorder symptoms and any potential side effects.

NCT ID: NCT06226233 Recruiting - Anorexia Nervosa Clinical Trials

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

Start date: December 23, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06198023 Recruiting - Anorexia Nervosa Clinical Trials

Targeting Social Function to Improve Outcomes in Eating Disorders

SF-ED
Start date: February 28, 2024
Phase: N/A
Study type: Interventional

Social processing and cognition are often altered in patients with eating disorders. The goal of this clinical trial is to assess two different social therapeutic interventions -- one educational, one interactive -- for their effectiveness in improving clinical outcomes in patients with eating disorders. Patients in both interventions will receive education about social function in eating disorders, but those in the interactive treatment group will complete an additional collaborative art task. Participants will: - attend a baseline study visit to complete clinical interviews, cognitive testing, and behavioral tasks - complete a pre-intervention assessment with questionnaires - attend eight sessions of their assigned treatment group over the course of 12 weeks - complete three virtual follow-up assessments 4, 8, and 12 months from their baseline - attend a final study visit to repeat some clinical interviews, cognitive testing, and behavioral tasks Researchers will compare changes in eating disorder, mood, and anxiety symptoms as well as test results from baseline and final study visits for each group to see if - patients can be treated effectively with education alone or if an interactive group component produces additional benefits - cognitive and behavioral task performance are associated with recovery or illness state.