Clinical Research Directory

Study Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and a Waitlist Control for Eating Disorders in Type 1 Diabetes

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.

Developing an Artificial Intelligence (AI) Chatbot for Adolescents and Young Adults With Eating Disorders

The goal of this study is to develop and refine an artificial intelligence (AI)-powered Exposure Therapy for Eating Disorders chatbot web-app that effectively engages adolescents and young adults and decreases anxiety about weight gain. Participants will use the web-app as a supplemental therapeutic tool during their first six weeks of treatment in a Partial Hospitalization Program. Participants will complete assessments every two weeks, including: (1) semi-structured interviews about their experience with the chatbot web-app; (2) implementation outcome measures (e.g., feasibility, usability, acceptability); and (3) anxiety about weight gain.

Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing

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.

Building Healthy Eating and Self-Esteem Together for University Students

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.

Training App for Inhibitory Control Towards Food

The aim of this project is to test the feasibility, acceptability and clinical impact of a mobile app-based intervention (FoodTraining) to strengthen food-related inhibitory control over 4 weeks, in a sample of people with eating or weight disorders (i.e. obesity, binge-eating disorder (BED), or bulimia nervosa (BN)) receiving standard outpatient treatment (i.e., treatment as usual (TAU) encompassing guided self-help or psychotherapy, pharmacological therapy or diet). The training will be offered in addition to TAU (experimental group) and compared to TAU alone (control group). Participants will complete questionnaires to measure eating behaviour, eating disorder psychopathology, symptoms of anxiety, depression and stress, social functioning and quality of life at baseline, 4 and 8 weeks. They will also complete momentary assessments using a mobile application (FoodTracker) to report on food intake along with related thoughts, emotions, and behaviours and will wear small, non-invasive sensors to track real-time fluctuations in glucose levels for 15 days. Participants will also perform a food-related go-no go task and a food-related temporal discounting task at baseline, 4 and 8 weeks. Finally, this study will pilot the use of a semi-structured interview to characterise the history of weight, the appetite system, eating-related habits in the family and learning of eating behaviours and attitudes in people with eating or weight disorders.

Low Intensity Focused Ultrasound for Binge Eating Disorder

This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with Binge Eating Disorder (BED)

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.

Project THINK: Trajectories of Health, Ingestive Behaviors, and Neurocognition in Kids

Overweight/obesity and loss of control eating (characterized by the sense that one cannot control what or how much one is eating) are prevalent among children and adolescents, and both are associated with serious medical and psychosocial health complications. Although our recently published data suggest that youth with these conditions may have relative deficits in neurocognitive functioning, particularly working memory, understanding of how these processes and their neural correlates are related to change and stability in eating and weight-related outcomes over time is limited, thereby impeding development of targeted, optimally timed interventions. The present study aims to assess prospective associations between general and food-specific executive functioning and underlying neural substrates, and eating and weight outcomes among children at varying levels of risk overweight/obesity and eating disorders, which will help guide research efforts towards the development of effective prevention and intervention strategies.

Building an Equitable and Accessible System of Eating Disorder Care for VA, DoD, and Underrepresented Americans

When untreated, eating disorders present with tremendous burdens to affected active duty Service members and Veterans and their families, and are very costly to the DoD and VA healthcare system. A comparative effectiveness study with state-of-the-art virtual treatment for BN and BED specifically adapted for testing with the Veteran population and other underrepresented eating disorder populations will lead to major improvements in clinical outcomes. The treatment will be integrated with VA's newest telehealth technology to profoundly enhance access to care anywhere, at any time. This trial of therapist-led and self-help CBT treatments, combined with our expert panel methods to inform VA Clinical Practice Guidelines for Eating Disorders and plans for dissemination, will accelerate the pace for the transition of results both for large-scale deployment in the VA system and for real-world impact among diverse and underrepresented eating disorder populations.

Open-Label Safety Study of Solriamfetol in Subjects With Binge Eating Disorder

This is a Phase 3, multi-center, open-label study to evaluate the long-term safety and efficacy of solriamfetol in the treatment of binge eating disorder (BED) in adults.

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

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.

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.

Effects of Negative Affect in Individuals With Binge Eating Episodes

Binge-eating is characterized by recurrent episodes of eating large amounts of - typically high calorie - foods, eating much more rapidly than normal and until feeling uncomfortably full, as well as feeling disgusted with oneself, depressed, or guilty after those episodes. Two eating disorders are characterized by binge-eating as central diagnostic criteria, binge-eating disorder (BED) and bulimia nervosa (BN). Binge-eating episodes in BN, but not BED, are typically followed by compensatory mechanisms such as self-induced vomiting, and BED is typically associated with obesity, while BN is not. Behavior studies such as ecological momentary assessment (EMA) research of affect in an individual's naturalistic environment have shown that negative affect and negative urgency (the tendency to act rashly when distressed) often precede binge-eating. The Investigators want to answer the following questions: Can negative affect in BN and BED be linked to 1) altered dopamine related brain reinforcement learning, 2) to food value computation and cognitive control circuit function, and 3) can dopamine related brain activation predict eating and negative affect, indicating a brain based neurobiological vulnerability. Answering those questions will help to define binge-eating based on regulation of brain reward, cognition, and emotion circuit function and point toward potential psychopharmacological interventions to normalize brain function and behavior.

Project VIBE: Virtual Intervention for Binge Eating in Adolescents

The aim of this project is to pilot test a novel mobile app intervention for adolescents with dysregulated eating behaviors and elevated weight status. This intervention will incorporate evidence-informed strategies targeting self-regulation into cognitive-behavioral treatment for maladaptive eating. Adolescents will use the app for 16 weeks and provide feedback on its usability and effectiveness in managing dysregulated eating.

Treating Binge Eating and Obesity Digitally in Black Women

More than 30% of Black women with obesity binge eat. Binge eating may increase the risk for the development of metabolic syndrome and binge-eating-disorder (BED), which is associated with severe obesity. Though several effective treatments for binge eating exist, Black women have not fared well. Not only has their inclusion in treatment trials been limited, but when participating, they are more likely to drop out, and/or lose less weight, compared to their White counterparts. Furthermore, treatment for binge eating is often not available in primary care and community-based settings places where Black women are more likely to receive treatment for their eating and weight-related concerns. Currently, there is scant intervention research to treat binge eating in Black women. With the highest rates of obesity (57%) nationally, Black women are in need of culturally-relevant treatments for binge eating and weight gain prevention. Given the established relationship between frequent binge eating and subsequent weight gain, addressing binge eating among Black women with obesity is imperative.

Preventing Type 2 Diabetes in Black Emergent Adult

Black Americans are disproportionately affected by diabetes, with nearly double the rates of type 2 diabetes mellitus (T2DM), compared to non-Hispanic White adults. Though numerous factors affect these disparities, one modifiable risk factor may be that of binge eating (BE), which increases risk for binge-eating disorder (BED), which is associated with severe obesity, and often precedes a T2DM diagnosis, beginning in childhood or adolescence. Nearly 30% of Black women with obesity report binge eating episodes. Furthermore, given that binge and overeating may disparately increase the odds of obesity in Black adults (15-fold increase vs. 6-fold increase in White adults), reducing this behavior will be critical to prevent continued disparities in T2DM diagnosis. Given that Black women have the highest rates of obesity in the nation (57%), report disparate rates of weight gain between young adulthood and mid adulthood, and report disparate rates of emotional eating in adolescence, which is a risk factor for BE, one pathway to reducing disparities in T2DM risk in Black women may be to reduce binge eating and prevent weight gain in emerging adulthood (ages 18-25).

Study of Emotional Regulation and Underlying Prefrontal Activity in Binge Eating Disorder

The goal of this exploratory, interventional, multicentre study is to compare the prefrontal activity during a negative emotion regulation task in women with Binge-Eating Disorder (BED) and healthy women with and without Emotional Eating (EE). The aim of this study is to compare the prefrontal processing of cognitive control of emotions between BED and EE and to compare the emotional processing and emotional experience between BED and EE. The study will thus compare four experimental groups: patients with BED, BMI-matched healthy volunteers with EE, BMI-matched healthy volunteers, and healthy volunteers of normal weight without BED. Participants will perform a down-regulation task of negative emotions elicited by negative pictures. During this task, their cerebral activity will be recorded using functional near-infrared spectroscopy (fNIRS), as well as their autonomous activity (skin conductance, pulse rate, respiration rate).

Use of Circadian Reset Technology to Alter REM Sleep and Appetitive Control in Patients With Binge Eating Disorder

This project includes testing circadian reset technology (CRT) on frequency of binge eating in a sample of 40 individuals with binge eating disorder. Participants will be randomized to one of two groups. Both groups use a virtual reality (VR) headset for 10 minutes (5 upon waking, 5 before sleep) daily for 1 month. One group will use the CRT software on the headset and the other group will use a software intended to be a control. Measures will be taken at baseline and 1-month. The researchers anticipate that use of CRT will improve sleep quality leading to increased appetitive control.

Eating Disorders Genetics Initiative 2

The overarching intention of the Eating Disorder Genetics Initiative 2 (EDGI2) is to increase sample size, diversity, and eating disorder phenotypes. The investigators are enrolling 20,000 new participants with anorexia nervosa (AN), bulimia nervosa (BN), binge-eating disorder (BED), avoidant/restrictive food intake disorder (ARFID), and controls in the US, Mexico, Australia, New Zealand, Sweden, and Denmark. A primary study goal is to enroll at least 30% of participants from underrepresented groups. Participants are asked to complete a series of questionnaires and submit a saliva sample for genotyping. The goal is to better understand eating disorders and how they relate to each other so that better treatments can be developed.

Relationships Between Exercise and Appetite in Women With Loss of Control Eating

This pilot study is a first step in looking at the relationship between exercise and appetite in women with loss of control eating.

Profiling the Dynamic of Binge Eating Disorder (PRODY-BED)

The goal of this observational study is to explore if different and specific profiles can be identified in adults with binge eating disorder (BED) depending on their additional eating pathology, emotion regulation and executive functions. The main questions it aims to answer are: * Is there different and specific subgroups of patients with BED according to baseline profiles in emotion regulation, executive function and additional eating pathology (including restriction, chaotic eating, grazing and eating on external cues)? * Are subgroups of individuals with BED (based on identified profiles) associated with outcome at end of treatment and follow-up? * What is the trajectories in remission rates of specific symptom dimensions (eating disorder pathology, emotion regulation, executive function, and depressive symptoms) in individuals with BED and is there specific trajectory profiles in these dimensions? * Is early changes in specific symptom dimensions (eating pathology, emotion regulation, executive function, or depression) associated with outcome of BED? Participants will be asked to fill in questionnaires before treatment as usual, 10 weeks into treatment, at end of treatment and at 6- and 12-month follow-up.

Compuls-BED-Severity

* Binge Eating Disorder (BED) has been fairly recently introduced into the Diagnostic and Statistical Manual 5 psychiatric classification and its severity criteria are still not well established. * Moreover, it remains unclear whether BED is associated with greater metabolic severity or more somatic comorbidities, especially in obesity. * Improved BED severity staging could lead to a better definition of management strategies and , therefore, facilitate screening and care. The investigators' hypothesis is that an improved assessment of the impulsivity-compulsivity spectrum, emotional regulation, attentional impairment and somatic or psychiatric comorbidities will result in a better distinction between the severe form of BED (e.g., highly impulsive and somatically complicated) from milder form (e.g., more compulsive and less somatically complicated).

Unfolding Severe and Enduring Eating Disorders (U-SEED)

The main aim of this study is to identify biological and psychological characteristics as risk factors in individuals with severe and enduring eating disorders (SEED). Specifically, the investigators aim to: 1. in a cohort of well-diagnosed eating disorder patients from 2005 followed up in National health registers, explore risk factors at baseline (recorded 2005-2007) for development of later SEED (the registry based cohort). 2. replicate the findings in a new sample of 50 adults with ongoing SEED. Participants will be assessed diagnostically and physically, and asked to fill out questionnaires and leave blood samples (the ongoing SEED sample compared with the register based cohort). 3. in a sample of 50 adults with SEED, explore demographic, biological, clinical, and psychological factors and examine the relation between these factors and symptom severity and functional impairment (the ongoing SEED sample). 4. explore participants perspectives on their symptoms and received care (the ongoing SEED sample).

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

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.