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Anorexia Nervosa clinical trials

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NCT ID: NCT05756530 Recruiting - Anorexia Nervosa Clinical Trials

The Experience of Affective Touch in Anorexia Nervosa

AffTouch_AN
Start date: October 6, 2021
Phase:
Study type: Observational

The aim of the present research will be to verify if the pleasantness of affective touch is comparable between women with AN and healthy women while measuring the level of social anhedonia and the lifespan experience of affective touch.

NCT ID: NCT05753410 Recruiting - Anorexia Nervosa Clinical Trials

App-Based Mindfulness Training for Individuals With Anorexia Nervosa and Bulimia Nervosa

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

We will evaluate the acceptability and feasibility of a 8-week long digital mindfulness-based intervention for anorexia nervosa and bulimia nervosa. This study is a prospective single-arm trial during the intervention development phase. Following this phase, after the intervention has been further developed, a subsequent study (with a different clinicaltrials.gov identification #) will utilize a randomized control trial design.

NCT ID: NCT05682417 Recruiting - Anorexia Nervosa Clinical Trials

Impact of Body Schema Distortion on Remission and Weight Regain in Anorexia Nervosa

SCAM
Start date: September 2024
Phase: N/A
Study type: Interventional

Anorexia nervosa is a predominantly female eating disorder that most often appears in adolescence. The latter leads to strict and voluntary food deprivation for several months or even years. The lifetime prevalence of anorexia is 1.4% in women and 0.2% in men. Ultimately, only half of people treated for anorexia nervosa in adolescence recover, 30% simply improve, 21% suffer from chronic disorders and 5 to 6% die. At the same time, between a quarter and half of patients abandon their current treatment, including during hospitalization. Relapses occur during the evolution of anorexia nervosa. Even more worrying, mortality is highest the year following the patient's discharge from hospital. This appears to be due to somatic complications in more than half of cases (most often cardiac arrest), to suicide in 27% of cases. Researchers are still trying to clarify the mechanisms involved in the emergence and persistence of this disorder. The objective is to obtain more verified and faster cures. However, the obstacles to successful treatment are mainly due to the denial of disorders and thinness. From a neurocognitive perspective, the representation one has of one's body is underpinned by two types of representations, i.e. body image and body schema. It has long been shown that body image is altered in anorexia nervosa. More recently, authors have shown that the distortion of the body representation was however more extensive and also affected the body schema. Patients find themselves too fat despite obvious thinness and move through space as if this were really the case. Worryingly, these distortions in bodyschema seem to persist after therapeutic management. Despite the potential role of body-scheme distortions in maintaining the disorder, as well as the risk of relapse, the difficulties in assessing body-scheme are significant. Indeed, recovery in these pathologies is often determined according to the Body Mass Index, self-declaration and questionnaires evaluating body image, again limiting the verification of the resorption of distortions in the body schema. Investigators have therefore developed the systematic, ergonomic and simplified evaluation of the body schema in patients suffering from anorexia nervosa at the time of diagnosis in an expert center, but also during follow-up evaluations thanks to the use of an evaluation platform of the body schema, i.e. the body in brain platform, developed by the LIP/PC2S laboratory and the SATT Linksium which allows the evaluation of the body schema.

NCT ID: NCT05674266 Recruiting - Clinical trials for Anorexia in Adolescence

New Treatment Perspectives in Adolescents With Anorexia Nervosa: the Efficacy of Non-invasive Brain-directed Treatment

Start date: June 30, 2020
Phase: N/A
Study type: Interventional

The present randomized, double blind, placebo-controlled trial aims at evaluating the efficacy of a tDCS treatment in improving the clinical outcome of adolescents with AN and investigate brain mechanisms acting in AN.

NCT ID: NCT05632497 Recruiting - Anorexia Nervosa Clinical Trials

Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa

INT-METAVOSA
Start date: May 23, 2024
Phase:
Study type: Observational

The purpose of this study will be to study the association between the level of psychic symptomatic of anorexia nervosa (AN) (intensity of food restriction, symptoms of anxiety and depression) and alteration of host environment symbiosis and the mechanism (dysbiosis of intestinal microbiota, increase of intestinal permeability, immunity alteration and low-grade inflammation).

NCT ID: NCT05627583 Recruiting - Anorexia Nervosa Clinical Trials

Nutritional Rehabilitation and Markers of Severity in Anorexia Nervosa

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

The design of this project is a longitudinal trial in patients with Anorexia Nervosa (AN) during in-hospital rehabilitation. Τhe structure of the study, the questionnaires and data protection policy prepared exclusively for our study, have been reviewed and standardised at Institutional Review Boards (Ethics Committees, IRBs,) in Harokopio University of Athens (HUA), Eginition Hospital (EH), Attiko Hospital (AH) and Sismanoglio Hospital (SG). AN is a psychiatric disorder followed by a psychopathologic concerning of body image and very low body weight due to extreme self-starvation. The exact pathogenesis of AN remains unknown with neurobiological, gastrointestinal, neuroendocrinological, immunological, and genetic factors suspected to be implicated. Furthermore, many metabolic traits, biochemical, biological or/and anthropometrical, are manifested during the maintaining effort of patients to achieve lower body weight. Self-inflicted starvation is the primary and essential causation of the pathological outcomes of the disorder. These outcomes involve all biological systems and organs. The role of the immune system in AN is critical as levels of pro-inflammatory cytokines are increased and the immune system is dysregulated. Other contributors to AN pathogenesis have been proposed, such as increased oxidative stress, dysbiosis of the gut microbiota and altered metabolomic profiles. Treatment options for patients with AN constitutes outpatient and inpatient care accordingly with the severity of the disorder. So far, no biomarker has been strongly proposed as an indicator of the disorder's severity or for assessing the progression of the treatment. The purpose of this study is to assess and monitor the nutritional rehabilitation of patients with AN during hospitalization treatment. Throughout the treatment's course, nutrition and feeding process, vital signs, psychopathology and biological samples will be gathered and statistical analysis of these data is expected to reveal potential biomarker/s for monitoring the progression of recovery.

NCT ID: NCT05596799 Recruiting - Anorexia Nervosa Clinical Trials

Facing Eating Disorder Fears for Anorexia Nervosa

FED-F
Start date: December 8, 2022
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT05575466 Recruiting - Anorexia Nervosa Clinical Trials

Thromboembolism in Anorexia Nervosa

TEAN
Start date: November 15, 2022
Phase:
Study type: Observational [Patient Registry]

BACKGROUND: Sudden death due to thromboembolic (TE) events in patients with anorexia nervosa (AN) is well known. However, the incidence of TE events and the hemostatic balance in patients with AN are sparsely investigated. Also, associations between re-nutrition and the hemostatic balance have not been studied. OBJECTIVE: To describe the incidence of TE events in patients with AN compared to the background population, to characterize the hemostatic balance in AN compared to normal-weight women, and to assess the associations between the hemostatic balance and nutritional status, insulin sensitivity and cortisol level in women with AN. METHODS: The incidence of TE will be described using a Danish cohort of AN patients (n=10,049) with follow-up in national registries. A comprehensive battery of hemostatic biomarkers will be compared in a case-control study of 40 patients with AN and associations between hemostasis and nutritional status will be studied.

NCT ID: NCT05563649 Recruiting - Anorexia Nervosa Clinical Trials

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

Start date: March 17, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05554172 Recruiting - Anorexia Nervosa Clinical Trials

Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders

Start date: December 13, 2022
Phase: N/A
Study type: Interventional

This project includes a 4-week randomized trial comparing pre-meal vagal nerve stimulation (taVNS) to pre-meal sham stimulation. The aims will assess if taVNS results in greater satisfaction, greater calorie consumption, less self-reported fullness, decrease in eating disorder symptoms, and less anxiety than sham stimulation. Gastric parameters (rhythm, motility, and pH level) will also be measured to assess stimulation as a mediator of autonomous eating