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Bulimia Nervosa clinical trials

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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: March 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.

NCT ID: NCT06063278 Recruiting - Bulimia Nervosa Clinical Trials

Step by Step Group Therapy for Bulimia Nervosa: Effectiveness and Mechanisms of Change.

SBSBN
Start date: May 6, 2022
Phase: N/A
Study type: Interventional

This a pseudo-randomized clinical trial that examines if a specific group therapy for BN is effective in improving its symptomatology, and what variables mediate such improvements. To do so a sample of 100 patients with BN will be pseudorandomized in a Group Therapy for BN or in a control waiting list group. Patients will be assessed at baseline, at the end of the group therapy and at 2 year follow up.

NCT ID: NCT06050616 Recruiting - Anorexia Nervosa Clinical Trials

Multimodal Longitudinal and Predictive Modelling to Understand Eating Disorder Development

ESTRA-BED
Start date: November 15, 2023
Phase:
Study type: Observational

The aim of this observational study is to elucidate the biopsychosocial (including neural, psychological, and social) basis of eating disorders (EDs). The investigators will use functional and structural neuroimaging, psychological as well as environmental data to identify both shared and distinct behavioural/neural processes across ED diagnoses. The investigators will use advanced statistical methods such as machine learning based models. The investigators will carry out analysis on the data already collected in the STRATIFY (Brain network based stratification of reinforcement-related disorders, IRAS ID 218030) and IMAGEN studies (Reinforcement-related behaviour in normal brain function and psychopathology, reference PNM/10/11-126), including participants with Anorexia Nervosa (N=60), Bulimia Nervosa (N=52), Binge eating disorder (N=27) and healthy controls. In addition, the investigators will recruit 30 new participants with a binge eating disorder using the original STRATIFY study protocol to enlarge the binge eating disorder group, so that its sample size is comparable to the other groups. Participants will complete online questionnaires, take an online clinical interview, and undergo a research visit, including brain scans, collection of blood and urine samples, and assessment using a range of cognitive and behavioural measures.

NCT ID: NCT05995496 Recruiting - Bulimia Nervosa Clinical Trials

Changes in Inhibition and Valuation After Eating

Start date: December 12, 2023
Phase: N/A
Study type: Interventional

An impaired ability to exert control has been implicated in bulimia nervosa (BN), but this impairment may not represent a stable trait or be the most effective focus for treatment. This project aims to understand how predictions and value-based decisions about control may be abnormally influenced by eating in individuals with BN, thereby maintaining cycles of binge eating, purging, and restriction.

NCT ID: NCT05937243 Recruiting - Bulimia Nervosa Clinical Trials

Identifying Effective Technological-based Augmentations to Enhance Outcomes From Self-help Cognitive Behavior Therapy for Binge Eating

CONQUER
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to test the feasibility, acceptability and efficacy of two technology-based intervention systems (including an Advanced Digital Data Sharing (ADDS) with Coaches or a smartphone-based just-in-time, adaptive interventions (JITAIs) system) for improving treatment adherence, skills utilization and binge eating when used in conjunction with a self-help cognitive behavior therapy [CBT] delivered via a smartphone application [app]). The study is being conducted to test a novel approach to providing evidence-based treatment for binge eating without clinician support in a routine clinical setting.

NCT ID: NCT05911334 Recruiting - Anorexia Nervosa Clinical Trials

Feasibility of the ROADE Program

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

Occupational therapy is uniquely poised to help address chronic Eating Disorders (EDs) because of our holistic approach to client care. The complex and serious nature of EDs spans so many areas of life and wellbeing, it requires an intervention strategy that addresses the whole person across mental, physical, social, and spiritual realms. Unfortunately, specialized care for EDs can be difficult to find - especially for those not sick enough to be admitted to an inpatient facility but who are still struggling to thrive in daily life. For example, in New Mexico there is only one inpatient treatment center for EDs and no specialized outpatient services. This leaves many people suffering from EDs without options for care because they are not yet sick enough. There is a need for novel interventions in this setting that go beyond the traditional weight and food-focused medical interventions and seek to help empower individuals, work around challenges, and live their lives to the fullest. To meet this need in our community, the study team is developing a preliminary outpatient treatment program. The ROADE (Restorative Occupational Approaches for Disordered Eating) Program is an 8-week, structured, multimodal intervention seeking to reduce psychosocial symptoms and improve self-management skills for disordered eating. The intervention strategies range from: (1) wellness activities like mindfulness meditation to improve interoception, self-acceptance, and as a self-guided coping tool (2) adaptation of health management and self-care occupations to improve daily functioning while navigating ongoing disordered eating symptoms and (3) light exercise like Yoga and lymphatic drainage exercises to reconnect in a positive way with the body, improve digestion, promote relaxation, and reduce muscle tension. The current research investigates the feasibility and acceptability of this intervention while testing preliminary effects on eating disorder symptoms.

NCT ID: NCT05879679 Not yet recruiting - Bulimia Nervosa Clinical Trials

Pilot Study on the Validity of the Metacognitive Hub Model of Craving in Bulimia Nervosa (BN) and Binge Eating Disorders (BED)

MetaBou
Start date: January 8, 2024
Phase:
Study type: Observational

Craving is defined as an irrepressible urge to consume certain products and represents one of the key factors in severe substance use disorders, as illustrated by its recent inclusion as a diagnostic criterion in the most recent fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM 5). However, the pathophysiological models of craving remain debated. The "metacognitive hub model", a conceptual, experimental and clinical approach to craving, proposes that craving should be considered as the embedded consequence of the interaction between three components (the reflexive, automatic and interoceptive systems), each of which has an implicit and explicit element. This model links the three components by suggesting that metacognitive abilities, the ability to understand one's own cognitive functioning, may be a skill of individuals that allows them to make the three sub-components explicit or not. To date, the conception of eating disorders is increasingly similar to that of addictive disorders. Indeed, there is growing evidence that the symptomatology of bulimia nervosa and binge eating disorder can be considered in part as an "food addiction" and would fit the diagnostic criteria of an addictive disorder. Bulimia nervosa is an eating disorder (DSM 5) characterized by a cycle of binge eating and compensatory behaviors such as self-induced vomiting that tend to negate or compensate for the effects of the binge eating. Binge eating disorder (DSM 5) is characterized by a cycle of binge eating, but without the compensatory behaviors seen in bulimia nervosa. In addition, there are common neurological aspects as well as similar cognitions between these eating disorders and addictive disorders. Given the importance of craving in addictive pathology, it seems essential to address this issue in bulimia nervosa and binge eating disorder. The cognitive difficulties of patients with bulimia nervosa and binge eating disorder, which are close to the difficulties observed in patients with addictive behaviors, suggest that the "metacognitive hub model" could provide a clear and measurable theoretical framework of the different dimensions of craving. The overall objective of this project is to explore the relationship between the level of craving induced by food picture exposure and the level of impairment of the reflexive, automatic, interoceptive, and metacognitive systems in women with bulimia nervosa and binge eating disorder and to compare these impairments according to the nature of the eating disorder (i.e., binge eating versus bulimia nervosa). Our hypotheses are: 1. the induction of food craving will affect the reflexive, automatic, and interoceptive systems of patients with bulimia nervosa and binge eating disorder. 2. the magnitude of the effect of food craving induction on implicit craving and explicit craving will be modulated by the participants' metacognitive abilities.

NCT ID: NCT05862389 Recruiting - Anorexia Nervosa Clinical Trials

Study on the Mechanism of Eating Disorder

Start date: September 1, 2022
Phase:
Study type: Observational

Eating disorders (EDs) are severe chronic psychiatric disorders with a not fully understood etiopathogenesis. Previous studies have revealed some biological mechanisms of EDs. However, the etiology and maintenance mechanism of EDs, especially the neuro-mechanisms is still unknown. To explore the pathogenic mechanism and treatment biomarkers of EDs, we design this study. the multidimensional data including the clinicopathological features, neuroimaging data (functional and structural magnetic resonance imaging), electroencephalogram and inflammatory cytokines will be used to investigate the biomarkers for diagnosis and treatment effectiveness.

NCT ID: NCT05812950 Recruiting - Anorexia Nervosa Clinical Trials

Clinical and Cost-effectiveness of Group Schema Therapy for Complex Eating Disorders: the GST-EAT Study

Start date: July 24, 2023
Phase: N/A
Study type: Interventional

Amongst psychiatric illnesses, eating disorders (EDs) are notoriously difficult to treat and have a high mortality rate. The average duration of an ED is 6 years and for a majority of ED patients, the disorder will become chronic. Comorbid personality pathology such as negative core beliefs and early maladaptive schemas (EMS) are strongly related to ED severity and chronicity. Enhanced cognitive-behavioural therapy for eating disorders (CBT-E) is used as the first line transdiagnostic treatment for EDs. However, CBT-E is mainly symptom-focused and does not tap into these underlying core beliefs and EMS. Given the limited treatment effects of existing ED treatments, and the importance of comorbid personality pathology, there is an urgent need to examine more effective treatments for EDs. Group-schematherapy (GST) overcomes the limitations of CBT-E and preliminary results for treatment-resistant EDs are promising. However, robust evidence regarding the clinical and cost-effectiveness of GST for patients that do not benefit from CBT-E is not yet available. The central aim of this project is to investigate the clinical and cost-effectiveness of GST for EDs in patients with comorbid personality pathology, who do not show a clinically significant response in the first phase of CBT-E. This is relevant and important as studies examining the effectiveness of GST for EDs are scarce. This project is a joint research initiative of three academic centers (Dutch Universities), four large nation-wide mental health organizations, and two foundations for client empowerment and participation. Eligible patients will be randomized to either GST or continuation of their CBT-E treatment after failing to show a significant treatment response in the first phase of CBT-E. Based on encouraging findings from previous studies and our own pilot data, a statistically and clinically significant better outcome in terms of ED symptoms, negative core beliefs, EMS, schema modes, and quality of life is expected in the GST group compared to the CBT-E group. GST is also expected to be more cost-effective compared to CBT-E as GST may in the long run prevent chronicity in terms of long treatment trajectories and delayed recovery. Finally, with the proviso of good results for GST, we will disseminate and implement GST in the standard of care for EDs. This project thereby has great potential to improve clinical and cost-effectiveness of treatment for chronic EDs.