Clinical Research Directory

Exploratory Study of Sensory Profile and Coping Strategies in Eating Disorders

This descriptive study aims primarily to characterize the sensory profile of patients with eating disorders (divided into three diagnostic groups: anorexia nervosa, boulimia nervosa and hyperphagia), controlling for possible autistic traits in this population. The study involves measuring characteristics associated with eating disorders (diagnosis, BMI, anxiety), assessing the sensory profile (AASP), and coping strategies in patients with eating disorders who are hospitalised or followed up in consultation.

Targeting Social Function in Anxiety and Eating Disorders

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.

Cerebellar tDCS Stimulation in Children and Adult Women With Anorexia Nervosa Disorder

Hypothesis: Will the use of tDCS brain modulation in the cerebellum assist in restricted behaviors, social cognition and cognitive flexibility in women with anorexia nervosa in addition to other therapies? Primary Outcomes: 1. To observe the impacts and outcomes of cerebellar transcranial direct current stimulation (tDCS) on social behaviors measured by Cyberball and Trust Game. 2. To observe the neuropsychological impacts of cerebellar tDCS through fMRI imaging as well as looking at the Region of Interest (ROI) of changes in the Default Mode Network and Cerebellum circuits and their activation levels in those networks. Secondary Outcomes: 1.To observe the impacts and outcome of cerebellar transcranial direct current stimulation (tDCS) measuring the differences between anodal and cathodal stimulation. To observe potential increases in responses to social stimuli, decreases in eating disorder/depressive symptomology via cathodal stimulation. To also observe potential little to no changes in social stimuli and eating disorder/depressive symptomology via anodal stimulation.

Severe Decrease of Growth Velocity in Children With Anorexia Nervosa.Therapeutic Trial of Growth Hormone

Anorexia nervosa may be responsible for a catch- down or even an interruption of growth, delayed puberty and osteopenia with failure of acquisition of bone mass. The recovery of normal nutrition usually leads to a resumption of growth and pubertal development. However, despite a therapeutic nutritional and psychotherapeutic satisfactory approach, some patients have a significant short stature with reduced adult final height and a deficit of bone mass. The main objective is to evaluate the effect of growth hormone (hGH) treatment on the growth velocity in prepubertal children or children in early puberty with anorexia nervosa and significant reduction of height velocity. This is a single-center, controlled, randomized and double-blind clinical trial evaluating the efficacy of hGH treatment for 1 year against a placebo, on the growth velocity of prepubertal or children in early puberty with Anorexia nervosa and major catch-down.This period is followed by the evaluation of the hGH treatment in children receiving placebo and continued hGH treatment in the treatment arm for 1 year, in total 2 years of study for each child. This second period corresponds to an ethical consideration giving secondarily access to treatment for patients in the placebo group.

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

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.

Specialist Supportive Clinical Management (SSCM) for Children and Adolescents With Anorexia Nervosa and Atypical Anorexia Nervosa

This study evaluates an adaptation of Specialist Supportive Clinical Management (SSCM) for children and adolescents aged 13-17 years with anorexia nervosa or atypical anorexia nervosa receiving outpatient treatment at the Stockholm Centre for Eating Disorders. SSCM may be offered when other recommended treatments, such as Family-Based Treatment (FBT) or Enhanced Cognitive Behavioral Therapy (CBT-E), are not considered suitable. The primary aim is to evaluate the feasibility and adherence of SSCM for children and adolescents, including treatment completion and attendance. The study will also explore preliminary treatment effects, including changes in eating disorder symptoms, weight, psychological symptoms, and functioning. Participants and their caregivers will complete assessments before, during, and after treatment, with a follow-up three months after treatment completion. Patients and caregivers will also be invited to participate in qualitative interviews at the end of treatment to explore their experiences of SSCM.

An Open Trial of a Novel Pharmacotherapy for Habit Modification in Anorexia Nervosa

The purpose of this study is to test the feasibility and tolerability of donepezil in a small group of patients with anorexia nervosa (AN). Study participants will be receiving care at the New York State Psychiatric Institute Eating Disorders Unit. Study medication will be increased from 1 mg per day to a maximum of 5 mg per day for up to 8 weeks. Participants will be closely monitored for side effects by a research psychiatrist every week, in addition to the regular clinical monitoring they receive during inpatient treatment. The study will also include assessments of habit strength to measure any changes in maladaptive eating habits over the course of the treatment.

tDCS and Cognitive Training for Restrictive Eating Disorders

This study looks at adults with restrictive eating disorders who are currently receiving outpatient treatment for their eating disorder to examine whether a new brain stimulation technique called non-invasive transcranial direct current stimulation (tDCS) can enhance brain training. Participation involves interviews, assessments, 10 sessions of brain stimulation (active or sham), and computerized brain training over a 3-4 week period, with one post-intervention visit, and one 1-month follow-up visit.

A Study on the Effects of Combined FMT on Gut Microbiota and Eating Disorder Symptoms in AN

The goal of this clinical trial is to determine if Fecal Microbiota Transplantation (FMT) is effective in treating Anorexia Nervosa (AN). The study will also explore how FMT works. The main questions it aims to answer are: 1. What is the efficacy of combined FMT treatment in patients with AN? 2. What is the relationship between treatment efficacy and changes in gut microbiota, and what mechanisms underlie the effects of FMT in treating AN? Researchers will compare FMT to a placebo (a look-alike substance that contains no active ingredients) to see if FMT is effective in treating AN. Participants will: * Be hospitalized * Take FMT or placebo daily for 6 days * Provide stool and blood samples before and after FMT * Visit the clinic every 4 weeks for check-ups and tests

Influence of Control Deprivation on the Use of the Analytical Cognitive Style in Anorexic Subjects

The use of an analytical cognitive style is a specific feature of anorexia nervosa and is thought to contribute to the maintenance of the disorder, in particular by encouraging fragmented body perception and a focus on certain parts of the body to the detriment of overall harmony and coherence. The need for control has also been described as an important element in the pathology. At the same time, some authors have shown that, outside of any pathology, recourse to the analytical cognitive style could respond to a need to restore control and, in turn, improve the feeling of control. However, at present, no causal relationship has been demonstrated between the feeling of loss of control and the analytical cognitive style in anorexia nervosa. However, such a relationship would enable us to gain a better understanding of the underlying mechanisms of the disorder and to better target the treatment of patients.

Contribution of a Virtual Reality Program in the Treatment of Dysmorphophobia for Adolescent Female With Anorexia Nervosa

Anorexia nervosa is an eating disorder that begins frequently in adolescence between the ages of 13 and 19, which affects girls with a sex ratio of 10:1, and the prevalence for females varies from 0,3% to 0,9%. The current therapeutic arsenal has a limited success in the treatment of anorexia nervosa with a long-term mortality rate and a 12-month relapse rate of up to 10% and 40%, respectively. One of the most difficult symptoms to treat is a body dysmorphic disorder, also called dysmorphophobia, the persistence of this symptom is a major negative prognostic factor. The main treatment of dysmorphophobia is currently cognitive behavioral therapy (CBT). In most protocols, the technique of progressive exposure face to the mirror is used with low efficiency. Adapted physical activity has recently been proposed in the literature as a tool to improve body perception. Face of complex management of this major symptom that is dysmorphophobia, some offer to use virtual reality. It is in this context that the study proposes to study the contribution of virtual reality in the treatment of the body dysmorphic disorder of adolescent patients hospitalized for anorexia nervosa in the department of Child and Adolescent Psychiatry Salvator Hospital in Marseille. It will be compare the importance and the evolution of the dysmorphophobia between two groups of teenagers hospitalized in Space Arthur for anorexia nervosa: an experimental group receiving the treatment with the contribution of the virtual reality, and a control group receiving the reference treatment of dysmorphophobia used in our unit. It will be recruit 30 adolescent females with anorexia nervosa according to the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM)-5. The subjects will be divided into 2 groups of 15 teenagers, according to a randomization list, a group with a classic protocol, a group with virtual reality. The subjects with virtual reality will have 5 exposure sessions where they will be able to model their body in view in 1st person and 3rd person, via an Oculus Rift. It will be compare the following parameters: the different scores related to dysmorphophobia according to different questionnaires, the self-evaluation of the Body Mass Index (BMI), in order to observe the evolution of the symptom, then the anxiety relative to the exposure of a BMI higher in order to work the fear of getting fat, the choice of the most pleasant BMI, to evaluate skinny body addiction. At the end of the study, we hope to highlight the effectiveness of virtual reality to fight against dysmorphophobia, in order to have a better estimate of its body aspect, and to impact the evolution towards the cure in anorexia nervosa in teenage girls. In addition to increasing our knowledge, this could allow to consider new strategies in the management of anorexia nervosa, and why not democratize more virtual reality with adolescents followed in child and adolescent psychiatry.

Adapting Exposure for Adolescent AN

This pilot study is evaluating Exposure Therapy (Exp-AN) as a virtual treatment for adolescents (ages 14 - 17 years) with anorexia nervosa (AN) recruited from eating disorder clinic waitlists and clinician referrals at the Penn State Milton S. Hershey Medical Center and the University of California, San Francisco (UCSF) (8 participants per site). Adolescents who agree to take part in this study will receive 20 free virtual 40-60 minute weekly Exp-AN sessions at an outpatient level of care. Exp-AN for adolescents will combine individual virtual session time (35-50 min) with parent involvement (10-25 min). Parents will serve as "collaborators," supporting skill development, exposure completion, and treatment goal achievement. Exp-AN sessions will focus on helping participants overcome anxiety about weight gain by encouraging them to do challenging things that increase anxiety in the short term but help them better tolerate anxiety over the long term. Participants will be asked to complete a clinical interview, questionnaires, and labs and vitals testing before they begin the study. Adolescents will also complete questionnaires and participate in 15-min semi-structured interviews, while parents/caregivers will complete separate parallel interviews, at: mid-treatment, end-of-treatment, and 3-month follow-up. To ensure that all participants are receiving the same type of therapy, they will not be able to have any concurrent psychotherapy while receiving this treatment (other forms of care including dieticians, nutritionists, and psychiatrists are allowed). Exp-AN is designed to target anxiety about weight gain. Exp-AN includes education about the effects of undereating; the importance of overcoming anxiety about weight gain; in-session weight exposures (e.g., stepping on a scale while reading a script describing fears about weight gain); creating a meal plan to help improve eating; reviewing eating behaviors over the past week; conducting in-session and between-session exposures that help participants face fears related to weight gain; and relapse prevention.

Fecal Microbiota Transplantation in Females With Anorexia Nervosa

The goal of this clinical trial is to learn whether fecal microbiota transplantation (FMT) can change the gut microbiome and improve health outcomes in females with anorexia nervosa. FMT involves transferring microorganisms from the stool of a carefully screened healthy donor to the intestine of another person. In this study, FMT will be given as capsules that are swallowed by the participants. The main questions the study aims to answer are: * Does repeated treatment with FMT change the gut microbiome in females with anorexia nervosa? * Does FMT improve symptoms and other health outcomes related to anorexia nervosa? * How does FMT affect gastrointestinal function, including bowel habits and gut transit time in females with anorexia nervosa? * What medical problems or side effects do the participants experience during the study? Researchers will compare FMT capsules with placebo capsules to see whether FMT affects the gut microbiome, gastrointestinal function, and symptoms related to anorexia nervosa. Placebo capsules are similar to the FMT capsules but do not contain donor fecal material. Participants will: * Receive five weekly FMT treatments and five weekly placebo treatments * Be randomly assigned to receive either FMT followed by placebo or placebo followed by FMT * Attend four study visits for clinical assessments and follow-up * Provide stool and blood samples at the study visits * Complete questionnaires about eating disorder symptoms, gastrointestinal symptoms, and general health * Provide information about bowel habits and other aspects of gastrointestinal function Neither the participants nor the study staff will know which treatment is being given during each treatment period. The study will include females aged 15 years or older with anorexia nervosa. The study will help researchers better understand the relationship between the gut microbiome and anorexia nervosa and whether changing the gut microbiome with FMT could potentially be a future treatment approach.

Treatment of Anorexia Nervosa in Children and Adolescents: An Integrated Family Based and Metacognitive Approach

The goal of this study is to evaluate the treatment effects of an integrated treatment called Family-based and Metacognitive therapy for patients with Anorexia Nervosa. In addition, we will evaluate if an active follow-up of the patients will reduce the number of relapses, which is common during the 1 year after discharge. Fifty patients aged 12-18 years old and their parents will be invited to participate in this study and all will receive the same treatment but be randomly allocated to different follow-up conditions. The active follow-up includes 3 sessions of Metacognitive therapy and the passive follow-up includes ordinary follow-up, with no booster sessions. The patients will be assessed at baseline, pre-treatment, post-treatment, and at 6 and 12 months follow-up.

Ketamine Effects on Learning In Eating Disorders

This is a single site, single dose clinical trial of intravenous (IV) ketamine for medically hospitalized adolescents and young adults with anorexia nervosa or atypical anorexia nervosa. Eating disorder symptoms will be measured pre- and post-ketamine infusion. Investigators hypothesize that ketamine will increase cognitive flexibility, making medical hospitalizations less distressing by improving the ability to learn new, positive associations with food.

Incorporating Narrative Into the Treatment of Youth With Anorexia Nervosa (Virtual)

The goal of this clinical trial is to evaluate whether a narrative medicine (NM) curriculum can enhance self-expression, reflection, and resilience in adolescents and young adults with anorexia nervosa. The main questions it aims to answer are: * Does participation in an NM curriculum improve self-expression and reflection in individuals with anorexia nervosa? * Does engaging in creative writing and group discussion promote resilience and emotional processing in this population? Participants will be 16-25 years old, medically stable for outpatient eating disorder therapy, and actively engaged in treatment. Those with active suicidal ideation, recent non-suicidal self-injury, or a co-occurring personality disorder will not be eligible. Participants will: * Attend six weekly workshops focused on themes such as self-definition, kindness, resilience, and possibility * Engage in close reading of visual or written texts * Complete creative writing exercises in response to prompts * Participate in group discussions and sharing An optional capstone reading event will provide a supportive space for participants to share their work with peers, loved ones, and providers, fostering connection and community. This study aims to explore the role of narrative medicine in eating disorder treatment and assess its potential benefits for psychological well-being and self-expression.

Circuit-Guided Neuromodulation for Anorexia Nervosa

The goal of this clinical trial is to find out whether personalized, non-invasive brain stimulation can temporarily change communication within brain networks related to restrictive eating in adults with anorexia nervosa. The main questions this study aims to answer are: * Does personalized transcranial magnetic stimulation (TMS) change functional connectivity within a brain network related to restrictive eating compared with sham stimulation? * Do different types of TMS affect measures related to inhibitory control, body image, eating-disorder symptoms, mood, and anxiety, and are they safe and well tolerated? Participants will: * Attend four study visits, separated by at least one week. * Complete clinical and psychological assessments and undergo brain magnetic resonance imaging (MRI). * Receive three stimulation conditions in random order at separate visits: intermittent theta-burst stimulation (iTBS), continuous theta-burst stimulation (cTBS), and sham stimulation. * Complete brain MRI scans and research tasks so that the effects of the three stimulation conditions can be compared. Researchers will compare the effects of iTBS and cTBS with sham stimulation on brain connectivity and other study measures. This is an exploratory proof-of-concept study designed to test whether personalized brain stimulation can engage the targeted brain circuit. It is not designed to determine whether TMS is an effective treatment for anorexia nervosa, and direct clinical benefit to participants is not expected.

Anorexia Nervosa, Evaluation and MOdification of Attention

Anorexia nervosa (AN), characterized by abnormally low weight, a significant fear of gaining weight, and impaired body perception, is a psychopathological disorder with a 1% prevalence. This disorder has particularly high relapse and mortality rates, highlighting the need for improved patient care. Indeed, patients are often hospitalized, which cuts them off from their environment and contributes to the high risk of post-hospitalization. It therefore seems essential to develop intervention tools that can be used in daily life, to continue treatment in a self-reliant way outside the hospital. Several factors contributing to the maintenance of AN were identified in the literature, including an attentional bias away from food cues. We can also mention a deficit of interoceptive awareness (i.e. low awareness of one's own bodily signals), as well as higher levels of anxiety than in the general population. Physiological dysfunction has also been observed, both at rest and when exposed to food stimuli. Acting on these aspects has led to clinical improvement in several disorders, including anxiety and alcohol use disorder. Given these elements, the investigators propose the implementation of attentional bias modification training in patients suffering from AN. Attentional bias modification training's first aim would be the reduction of food avoidance, while secondary hypotheses postulate that the intervention could have an effect on interoceptive abilities and physiological functioning. This intervention, which can be used by patients themselves, has also shown its effectiveness in reducing anxiety. A reduction in anorexic symptoms and prognosis improvement is expected.

Family Therapy and Anorexia Nervosa : Which is the Best Approach?

The aim of this study is to evaluate whether the implementation of Multiple Family Therapy (MFT) within a multi-disciplinary treatment program for Anorexia Nervosa (AN) in adolescence is at least as effective in terms of clinical Body Mass Index evolution as single Systemic Family Therapy (SyFT) after 12 months of treatment. We expect that these two techniques will not differ in terms of global efficacy, but that MFT could be more suitable for certain profiles who may be less responsive to SyFT.

Exposure Therapy Study In Adults With Eating Disorders

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).

Open vs. Blind Weighing Study In Adolescents and Young Adult With Eating Disorders

Current treatments for adolescents and young adults (AYAs) with eating disorders (EDs) do not effectively address a central ED symptom - anxiety about weight gain - which contributes to poor outcomes. The proposed study evaluates the feasibility, acceptability, efficacy, and underlying mechanisms of an enhanced version of "open weighing," a cognitive-behavioral intervention designed to target anxiety about weight gain in AYAs with EDs. Understanding how to better treat AYAs with EDs, and identifying the mechanisms by which interventions lead to improvement, will aid in the development of more effective and personalized treatments, ultimately improving the lives of AYAs with EDs.

Reestablishing Normal Gut-brain Interaction in Anorexia Nervose With Normal Gut Microbiota

In this pilot study 36 patients with anorexia nervosa (AN) will be randomized to either treatment with psychotherapy as usual (TAU) or TAU plus fecal microbiota transplantation (FMT). The transplantation will be performed when refeeding has started. Patients randomized to TAU+FMT will choose either capsules or gastroscopy as source of FMT. One week after FMT gut microbiota will be collected and analyzed and compared with microbiota composition at baseline. The two groups are then followed during psychotherapy to assess whether it is feasible to give FMT during psychotherapy to study the effects on outcome. In addition, this pilot study is aiming at paving the way for performing larger studies to assess whether FMT improves outcome from psychotherapy when given in combination with psychotherapy in patients with AN.

Impact of Fatty Stimuli on Cerebral Activity in Anorexia Nervosa: a Multi-sensory Approach

Lipid restriction is significant in anorexia nervosa and limits therapeutic management. The multisensory perception of fat is altered, creating an aversion to lipids. The investigators aim to characterize the impact of sensory stimulation (smells or images) associated with specific tastes using neuropsychological assessments and functional MRI. Some volatile aromas can enhance the perception of the associated taste. The investigators hypothesize that such associations are altered in anorexia nervosa for fatty foods but may be preserved for sweet tastes, and that this alteration contributes to the maintenance of the disease. The interdependence of different sensory perceptions of lipids could play a major role in the therapeutic approach, aiding in the deconditioning of this aversion and the restoration of positive food sensory associations.

Impairment of Central Coherence in Restrictive Anorexia Nervosa (CoCA)

The current etiological pathological model of anorexia nervosa is poly-factorial involving individual genetic and psychological factors, in close interaction with environmental, family and socio-cultural factors. Among these factors, this study focuses on the central coherence process (cognitive ability to integrate complex information into a comprehensive meaning), in the active phase of the disease. Therefore, patients followed in the addiction service of the Nantes University Hospital will perform neuropsychological tests assessing executive functions involved in the process of central coherence. Impairment of central coherence process could act as a maintenance factor of the disease, particularly in connection with body dysmorphic disorder. The therapeutic perspectives acting on the central coherence process like cognitive remediation deserve to deepen knowledge on the cognitive profile of patients with anorexia nervosa.