# Eating Disorders

Eating disorders are serious and often fatal illnesses that are associated with severe disturbances in people’s eating behaviors and related thoughts and emotions. Preoccupation with food, body weight, and shape may also signal an eating disorder. Eating disorders are not a lifestyle choice. Common eating disorders include anorexia nervosa, bulimia nervosa, and binge-eating disorder. Learn more about eating disorders.

## Featured Studies

Featured studies include only those **currently recruiting participants**. Studies with the most recent start date appear first.

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### Innovations in Personalizing Treatment Study **

**Study Type:** Interventional**Start Date:** January 21, 2024**Eligibility:** 18 Years to 65 Years, Does Not Accept Healthy Volunteers**Location(s):** Eating Anxiety Laboratory and Clinic, Louisville, Kentucky, United States    

Eating disorders (EDs) are serious mental illness: someone dies of an ED every 52 minutes. EDs are highly related to a host of negative outcomes, including public health and individual disease burden, medical and psychological comorbidities, and social determinants of health (SDOH). Treatment response for EDs are suboptimal; there are no evidence-based treatment for adults with anorexia nervosa (AN) or Other Specified Feeding or Eating Disorder (OSFED) and only 50% of adults respond to current evidence based treatments. There are no precision treatments, nor any treatments that consider social context, in existence. Personalized treatments for EDs, that consider social contexts, are urgently needed to improve treatment response and minimize the suffering associated with these illnesses. The investigators' overall goal, extending upon their past work, is to create a treatment personalized based on idiographic (or one person) models (termed Transdiagnostic Network Informed Personalized Treatment for EDs; T-NIPT-ED). The investigators will carry out a two-phase study to systematically characterize individual mechanisms of treatment (Phase I: N=900) and then test the efficacy of each treatment module (Phase II: N=240 drawn from Phase I) compared to the current gold-standard treatment (Cognitive Behavioral Therapy Enhanced: CBT-E). The study goals are to (1) characterize the prevalence of T-NIPT-ED precision treatment mechanisms and medical and psychological comorbidities (e.g., obesity; depression), individual disease burden (e.g., disability), SDOH (e.g., food insecurity), and public health outcomes (e.g., service utilization) specific to these mechanisms, (2) identify if personalized target mechanisms improve when matched to evidence-based treatment modules of T-NIPT-ED and (3) test if change in T-NIPT-ED is associated with improved outcomes (vs CBT-E), including ED outcomes, comorbidities, disease burden, and public health outcomes and if these outcomes are moderated by SDOH. These goals will ultimately lead to the very first precision treatment for ED and can be extended to additional psychiatric illnesses. The proposed research uses highly innovative methods; intensive longitudinal data collected with mobile technology is combined with state-of-the art idiographic modeling methods to deliver a virtual, personalized treatment. This proposal integrates assessment of broad (e.g., SDOH; public health burden) and specific (e.g., ED symptoms) outcomes, to ensure that social context can be integrated into personalization. The proposed research has high clinical impact. Ultimately, this proposal will lead directly to the creation and dissemination of an evidence-based individually-personalized treatment for EDs, as well as will serve as an exemplar for precision treatment development across the entire field of psychiatry.

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### Changes in Inhibition and Valuation After Eating **

**Study Type:** Interventional**Start Date:** December 12, 2023**Eligibility:** Females, 18 Years to 45 Years, Accepts Healthy Volunteers**Location(s):** Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai, New York, New York, United States    

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.

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### Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa **

**Study Type:** Interventional**Start Date:** December 6, 2023**Eligibility:** 18 Years and Older, Does Not Accept Healthy Volunteers**Location(s):** Virginia Commonwealth University, Richmond, Virginia, United States    

The investigators will recruit individuals with broadly-defined AN (n = 80) who are currently in or have recently participated in higher-level eating disorder treatment (e.g., residential, partial hospitalization/day treatment, intensive outpatient treatment). Interested participants will sign consent, complete eligibility assessments, and will be randomized to receive Positive Affect Treatment for Anorexia Nervosa (PAT-AN) or Psychoeducation and Behavioral Therapy (PBT) through teletherapy shortly following discharge from higher level of care. Participants can participate in most other forms of outpatient treatment while receiving the research intervention. Participants will engage in 24 weeks of PAT-AN or PBT starting in the first 3 months post-discharge. At each session, the investigators will complete brief measures assessing treatment acceptability, affect, and eating disorder symptoms. Participants will also complete an assessment battery of self-report, EMA, and neurocognitive measures evaluating primary outcomes (BMI; eating disorder symptoms), secondary outcomes (depression, anxiety, and suicidality), and presumed treatment mechanisms at baseline, end of treatment (EOT), and 3-month follow-up (FU). All assessments will be remotely delivered via HIPAA-compliant platforms.

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### Response to Acute Exercise in Eating Disorders **

**Study Type:** Interventional**Start Date:** November 2, 2023**Eligibility:** Females, 16 Years to 22 Years, Accepts Healthy Volunteers**Location(s):** University of Wisconsin-Madison, Madison, Wisconsin, United States; University of California San Francisco, San Francisco, California, United States    

Individuals with eating disorders (ED) represent a high-priority clinical population, with among the highest mortality rates of any psychiatric disorder, and driven exercise (DEx) is a symptom evidenced in up to 80% of those with EDs that increases impairment and negatively impacts treatment outcome. This study will develop tasks to characterize cognitive, affective, and biological response to exercise among adolescent and young adult females with EDs and determine whether acute exercise response associates with free-living activity and DEx. This R21 project will provide foundational data to guide research and development of treatments that are more precisely targeted to the symptom of driven exercise and to ultimately improve clinical outcomes associated with EDs.

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### A Precision Medicine Approach to Target Engagement for Emotion Regulation **

**Study Type:** Interventional**Start Date:** September 29, 2023**Eligibility:** 18 Years and Older, Does Not Accept Healthy Volunteers**Location(s):** University of Kentucky, Lexington, Kentucky, United States    

The proposed study is designed to first test whether teaching people personalized or standardized emotion regulation skills leads to greater decreases in daily negative emotion intensity. Second, using data from an initial sample, the investigators will prospectively assign an independent sample of participants to receive their predicted optimal or non-optimal skills to determine if it is feasible and efficacious to match participants to the most appropriate training condition. Results of these studies may identify the mechanisms by which emotion regulation interventions impact emotional functioning and allow for the development of personalized, evidence-based, and scalable emotion regulation interventions.

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### Neurostimulation Versus Therapy for Problems With Emotions **

**Study Type:** Interventional**Start Date:** May 15, 2023**Eligibility:** 18 Years to 55 Years, Does Not Accept Healthy Volunteers**Location(s):** Duke University Medical Center, Durham, North Carolina, United States    

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.

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### Confirming the Effectiveness of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa **

**Study Type:** Interventional**Start Date:** March 17, 2023**Eligibility:** 12 Years to 18 Years, Does Not Accept Healthy Volunteers**Location(s):** McMaster University, Hamilton, Ontario, Canada; Stanford University, Stanford, California, United States    

With an incidence rate of about 1%, Anorexia Nervosa (AN) is a serious mental disorder associated with high mortality, morbidity, and cost. AN in youth is more responsive to early treatment but becomes highly resistant once it has taken an enduring course. The first-line treatment for adolescents with AN is Family Based Treatment (FBT). While FBT can be delivered using videoconferencing (FBT-V), therapists' limited availability hampers scalability. Guided self-help (GSH) versions of efficacious treatments have been used to scale and increase access to care. The main aim of this proposed comparative effectiveness study is to confirm that clinical improvements in GSH-FBT are achieved with greater efficiency than FBT-V in generalizable clinical settings.

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### Interoceptive Exposure for Adolescents With Low Weight Eating Disorders **

**Study Type:** Interventional**Start Date:** March 14, 2023**Eligibility:** 12 Years to 18 Years, Does Not Accept Healthy Volunteers**Location(s):** Department of Psychiatry, Eating and Weight Disorders Program, New York, New York, United States    

This project includes a parallel group randomized controlled trial comparing two psychological treatments: 1) Exposure-based Family Therapy (IE) vs. 2) Family Based Therapy (FBT) for low weight eating disorders with 12 month follow-up. Primary outcomes are expected body weight and clinical impairment. Three mechanisms of change (Autonomous Eating, Non-Judgmental Body Awareness, and Extinction Learning) will be examined in a process mediation models of change.

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### Optimizing Digital Health Technology Interventions to Increase Skill Acquisition and Utilization **

**Study Type:** Interventional**Start Date:** January 6, 2023**Eligibility:** 18 Years to 70 Years, Does Not Accept Healthy Volunteers**Location(s):** Drexel University, Stratton Hall, Philadelphia, Pennsylvania, United States    

The purpose of this study is to identify the independent and combined effects of two types of self-monitoring and two types of micro-interventions when combined with standard cognitive behavioral treatment for bulimia nervosa (BN) and binge eating disorder (BED). The primary aims of this study are (1) to evaluate the optimal complexity of Self-Monitoring and Micro-Interventions on eating pathology (at post-treatment and at 6 and 12-month follow-ups and (2) to test the hypotheses that the optimal complexity level of each component is moderated by baseline deficits in self-regulation. The secondary aim will be to test target engagement for each level of complexity for each component, i.e., to test whether higher complexity of each technological components is associated with better rates of therapeutic skill use and acquisition and that improvements in skill use and acquisition are associated with improvements in outcomes. A final exploratory aim will be to quantify the component interaction effects, which may be partially additive (because components overlap and/or there is diminishing return), fully additive, or synergistic (in that component complexities may partially depend on each other).

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### Genetic Architecture of Avoidant/Restrictive Food Intake Disorder **

**Study Type:** Observational**Start Date:** January 5, 2023**Eligibility:** 7 Years to 99 Years, Does Not Accept Healthy Volunteers**Location(s):** University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States    

The goal of this observational study is to rapidly accelerate knowledge about the biology of avoidant and restrictive food intake disorder or ARFID in children ages 7-17 and in adults. The investigators will be evaluating the genetic and environmental origins of ARFID. Participants will be asked to answer questionnaires online and to submit a saliva sample for DNA using a kit that will be mailed to their home.

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### Facing Eating Disorder Fears for Anorexia Nervosa **

**Study Type:** Interventional**Start Date:** December 8, 2022**Eligibility:** 18 Years to 65 Years, Does Not Accept Healthy Volunteers**Location(s):** Eating Anxiety Laboratory and Clinic, Louisville, Kentucky, United States    

FED-F is a modular treatment that enhances exposure therapy with psychoeducation and cognitive skills teaching how to face fears of (a) food, (b) weight gain, (c) interoception/body, and (d) social situations. The study goals are to (1) refine and test the acceptability and feasibility of FED-F treatment (Phase I), (2) test if this treatment outperforms treatment as usual (TAU) delivered post-acute treatment as adjunctive to stepdown specialty care (Phase II), and (3) to examine if treatment targets the hypothesized mechanism of action: approach behaviors (Phase II). These goals will lead to a highly deployable and accessible virtual treatment targeted at core AN mechanisms that predict relapse. Specific aims are to (1) refine FED-F into a fully virtual format with input from patients and stakeholders and collect preliminary data (N=10) on its feasibility and acceptability (Phase I), (2) conduct a small pilot RCT (randomized controlled trial) of FED-F (n=30) as compared to TAU (n=30; Phase II), and (3) examine if FED-F targets approach/avoidance behaviors and test if this mechanism is associated with clinical outcomes (Phase II).

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### Helping HAND: Healing Anorexia Nervosa Digitally **

**Study Type:** Interventional**Start Date:** December 1, 2022**Eligibility:** Females, 18 Years and Older, Does Not Accept Healthy Volunteers**Location(s):** Washington University School of Medicine, Saint Louis, Missouri, United States    

The proposed project will develop and pilot a coached mobile app, including a social networking component, for individuals with anorexia nervosa to use in the post-acute period

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### Project HOME: Home-Based Treatment Options and Mechanisms for Eating Disorders **

**Study Type:** Interventional**Start Date:** August 1, 2022**Eligibility:** 12 Years to 18 Years, Accepts Healthy Volunteers**Location(s):** Gateway Healthcare, Pawtucket, Rhode Island, United States; University of Pittsburgh, Pittsburgh, Pennsylvania, United States; The Providence Center, Providence, Rhode Island, United States    

This randomized, controlled effectiveness trial will assess outcomes, implementation, and mechanisms of two psychological treatments for adolescent anorexia nervosa (AN) delivered in the home setting, in the context of community-based mental health. Adolescents with AN-spectrum disorders (n=50) and their caregivers will be randomly assigned to either family-based treatment or integrated family therapy delivered in the home. Caregivers and adolescents will provide data on weight, eating, and putative treatment mechanisms, including caregiver self-efficacy, adolescent distress, and generalizability of treatment skills. Treatment feasibility, acceptability, and appropriateness will be measured among providers and participating families. The proposed study has clear potential to advance scientific and clinical understanding of the real-world effectiveness of psychological treatments for AN, including whether adapting them for the home setting may improve accessibility and effects on treatment outcome

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### Personalized Treatment for Eating Disorders Versus CBT-E Trial **

**Study Type:** Interventional**Start Date:** April 6, 2022**Eligibility:** 18 Years to 65 Years, Does Not Accept Healthy Volunteers**Location(s):** Eating Anxiety Treatment Laboratory and Clinic, Louisville, Kentucky, United States    

The scientific premise, developed from past work, is that treatment personalized based on idiographic models (termed Network Informed Personalized Treatment; NA-PT) will outperform the current gold-standard treatment (Enhanced Cognitive Behavioral Therapy: CBT-E). The study goals are to (1) develop and test the acceptability, feasibility, and preliminary efficacy of a randomization of NA-PT versus CBT-E and (2) to test if network-identified precision targets are the mechanism of change. These goals will ultimately lead to the very first personalized treatment for ED and can be extended to additional psychiatric illnesses. Specific aims are (1) To collect preliminary data on the feasibility and acceptability of the randomization of NA-PT (n=40) for EDs versus CBT-E (n=40), (2) To test the initial clinical efficacy of NA-PT versus CBT-E on clinical outcomes (e.g., ED symptoms, body mass index, quality of life) and (3) To examine if changes in NA-identified, precision targets, as well as in dynamic network structure, are associated with change in clinical outcomes.

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### Shifting Perspectives R33 Phase: Enhancing Outcomes in Anorexia Nervosa With CRT **

**Study Type:** Interventional**Start Date:** November 5, 2021**Eligibility:** 12 Years and Older, Does Not Accept Healthy Volunteers**Location(s):** Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States    

Anorexia Nervosa is a serious life-threatening illness with a typical age of onset in adolescence; if not effectively treated, it has the potential to significantly impact adolescent development and quality of life. Research on executive functioning in anorexia nervosa indicates that it may be a viable target for intervention that could improve outcome. The current project focuses on determining whether or not the investigators can improve set-shifting in affected adolescents in the hopes that improvements in set-shifting will, ultimately, improve outcome.

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### Online Relapse Prevention Study **

**Study Type:** Interventional**Start Date:** June 4, 2021**Eligibility:** 18 Years to 65 Years, Does Not Accept Healthy Volunteers**Location(s):** Eating Anxiety Treatment Laboratory and Clinic, Louisville, Kentucky, United States    

The purpose of this study is to collect preliminary data on the feasibility and acceptability of the randomization of two relapse-prevention treatment conditions after discharge from intensive eating disorder (ED) treatment: an imaginal exposure therapy and a writing and thinking intervention. The second aim to test for (a) differences between the two treatments for the prevention of relapse and (b) preliminary change on clinical ED outcomes (e.g., ED symptoms, fears). The investigators further aim to examine the two treatments target fear extinction and if fear extinction is associated with ED outcomes. The investigators also plan to test if baseline differences in fear conditioning relate to change in ED outcomes across treatment.

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### The Role of the Circadian System in Binge Eating Disorder **

**Study Type:** Interventional**Start Date:** January 15, 2021**Eligibility:** 18 Years to 50 Years, Accepts Healthy Volunteers**Location(s):** Lindner Center of HOPE / University of Cincinnati, Mason, Ohio, United States    

Binge eating disorder (BED) shows prominent circadian features that suggest a delay in circadian phase, and preliminary evidence shows binge eating may be responsive to chronobiological interventions, implicating a circadian system dysfunction in its pathophysiology. What remains lacking, however, is comprehensive knowledge of the characteristics of circadian system dysfunction in BED, and whether this dysfunction represents a therapeutic target in BED. There is therefore a critical need to characterize circadian system dysfunction in BED, and evaluate it as a potential therapeutic target. Without such information, the understanding on the role of the circadian system in BED and its potential as a new therapeutic target will remain limited.

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### Self-Control in Bulimia Nervosa **

**Study Type:** Interventional**Start Date:** September 18, 2020**Eligibility:** Females, 18 Years to 35 Years, Accepts Healthy Volunteers**Location(s):** Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai, New York, New York, United States    

This study examines the influence of acute fasting and eating on self-control in adult females with and without bulimia nervosa (BN). Specifically, the study team is investigating whether differences in behavior and brain activation in response to computer tasks after fasting and after eating a meal could help to explain the symptoms of bulimia nervosa. Data will be collected using questionnaires and a technology called magnetic resonance imaging (MRI).

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### Target Engagement of a Novel Dissonance-Based Treatment for DSM-5 Eating Disorders **

**Study Type:** Interventional**Start Date:** July 10, 2017**Eligibility:** Females, 18 Years to 34 Years, Does Not Accept Healthy Volunteers**Location(s):** Stanford University, Stanford, California, United States    

Most people with an eating disorder (ED) do not receive good treatment. The investigators have developed a new brief group treatment that is supposed to work by reducing how much women with an ED value the impossible thinness standard promoted by the media and how much they value/crave binge foods. The investigators want to test whether the treatment actually changes those two mechanisms using brain scan data, which is more objective than completing questionnaires and even interviews.

In the first phase of the study (R61), the investigators will compare women in the treatment versus those on a wait-list. If the investigators can show that the treatment "works" (does what the investigators think it does) compared to no active treatment (women will be allowed to seek and receive outside help but investigators will not provide it until after the wait-list), investigators will conduct the second phase of study (R33),where they will randomly assign women with an ED to either the new treatment or to a group treatment that represents what many college mental health clinics provide to their clients with ED.