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Eating Disorders clinical trials

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NCT ID: NCT06371963 Recruiting - Eating Disorders Clinical Trials

Relative Energy Deficiency in Sports (REDs) in Swedish Athletes

REDs-Sweden
Start date: May 10, 2022
Phase:
Study type: Observational

Background: Relative Energy Deficiency in Sport (REDs) describes impairment of health and performance due to problematic (long-term/severe) low energy availability (LEA), with or without eating disorders. LEA is frequently reported in sports with high training volumes, especially in leanness demanding sports, and 20% of female and 9% of male Norwegian national team athletes have been reported to have eating disorders. Potential trigger factors are e.g., dieting, injuries, coaching behavior, and subculture aspects e.g., focus on low body weight. The main questions that will be addressed are: 1. What is the prevalence of eating disorders and REDs among Swedish elite athletes and controls? 2. What is the impact of problematic LEA on health and performance aspects in both male and female athletes? Methods: National team athletes and gender and matched controls will be invited to an anonymous on-line survey. Elite athletes who agree to participate, will be invited to assessment of eating disorders, nutritional and physiological status (e.g., metabolic and endocrine markers, bone health, microbiota, dietary intake, energy availability, and performance).

NCT ID: NCT06359951 Not yet recruiting - Depression Clinical Trials

Implementation of Project YES in Ambulatory Adolescent & Young Adult Medicine

Start date: April 29, 2024
Phase: N/A
Study type: Interventional

This study tests a suite of single-session intervention (SSI) targeting risk factors for depression and eating disorders among adolescents and young adults. Youth ages 13-25 who screen positive for depression or anxiety as a part of routine care will be offered one of three digital SSIs. Participants will complete questionnaires before the intervention, immediately after the intervention, and 3-months after completing the intervention so that the study team can investigate if Project YES leads to reductions in depression, anxiety and eating disorder symptoms.

NCT ID: NCT06345040 Recruiting - Anorexia Nervosa Clinical Trials

The Dialogue Study: A Virtual-reality Based Treatment for Eating Disorders

Start date: February 26, 2024
Phase: N/A
Study type: Interventional

The Dialogue Study is a randomized, assessor-blinded parallel-groups superiority clinical trial fulfilling the CONSORT criteria for non-pharmacological treatment. The aim of the trial is to investigate the effect of a new virtual reality based psychotherapy for eating disorders. A total of 96 participants with a diagnosis of anorexia nervosa or bulimia nervosa will be allocated to either Virtual-reality therapy plus treatment as usual or treatment as usual. All participants will be assessed at baseline and 12- and 24 months post baseline. A stratified block-randomisation with concealed randomisation sequence will be conducted. Independent assessors blinded to the treatment will evaluate outcome. Analysis of outcome will be carried out with the intention to treat principles.

NCT ID: NCT06306586 Not yet recruiting - Eating Disorders Clinical Trials

A Digital Treatment for Adolescents With Eating Disorders

Start date: April 5, 2024
Phase: N/A
Study type: Interventional

The goal of this feasibility study is to evaluate the feasibility and preliminary clinical outcomes of a personalized digital treatment for adolescents with eating disorders. The main objectives are to: i) Evaluate whether a personalized digital treatment for adolescents with eating disorders are feasible in a child and adolescent psychiatric outpatient clinic. ii) Evaluate who benefits from a personalized digital treatment for adolescents with eating disorders (what works for whom?) iii) Evaluate the cost-benefit of a personalized digital treatment for adolescents with eating disorders. Participants will be enrolled in a 10-week digital treatment including weekly therapist contact. They will be asked to complete self-report questionnaires at pre-, during, post- and 3- and 6-months follow-up.

NCT ID: NCT06294353 Recruiting - Eating Disorders Clinical Trials

Study of Efficacy and Safety of WELT-ED for Eating Disorder (WCTP-ED-B-01)

Start date: March 29, 2023
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to evaluate the safety and efficacy of a digital therapeutic device (WELT-ED) based on Cognitive Behavioral Therapy (CBT) for the treatment of eating disorders. The main questions it aims to answer are: - Is WELT-ED as effective as standard treatment in reducing the symptoms of eating disorders? - Is the WELT-ED safe for use in the target population without causing adverse effects? Participants will: - Undergo assessments to determine their baseline health status and severity of eating disorder symptoms. - Use WELT-ED or receive standard treatment as directed for the duration of the study period (8 weeks). - Participate in assessments to monitor changes in their eating disorder symptoms and any potential side effects.

NCT ID: NCT06252688 Not yet recruiting - Eating Disorders Clinical Trials

Conceptualisation of a Network Approach to Complete the Classification of Eating Disorders With the Aim of Better Personalising Their Management

CASCADE
Start date: February 15, 2024
Phase: N/A
Study type: Interventional

Eating disorders (EDBs) are mental disorders with a great impact on the lives of individuals as well as a great cost imposed on society. The treatments currently available rely on different forms of psychotherapies with an unsatisfactory response rate as well as a considerable relapse rate . One of the reasons underlying the low success of available therapeutic modalities would be the heterogeneity of the clinical presentation of EDs, making their classification and the personalization of their treatment more difficult.The investigators hypothesize that a secondarily dimensional classification approach (respecting the categorical classification currently in use) of EDs based on the different dimensions disturbed in these disorders as well as in their comorbidities, would better represent their nosographic reality, which could provide patients with more personalized and potentially more effective care.

NCT ID: NCT06230107 Completed - Eating Disorders Clinical Trials

The Effects of Nutritional Intervention in Participants With Eating Disorders.

Start date: October 18, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the effects of nutritional intervention in eating disorders. Participants underwent an intervention without a control group over 8 weeks. This study aims to provide the maximization of nutritional rehabilitation and support changes in the construction of food autonomy, through a food and nutritional intervention.

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: NCT06213883 Recruiting - Eating Disorders Clinical Trials

Response to Acute Exercise in Eating Disorders

Start date: November 2, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06208605 Recruiting - Eating Disorders Clinical Trials

Innovations in Personalizing Treatment Study

T-NIPT-ED
Start date: January 21, 2024
Phase: N/A
Study type: Interventional

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.