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Anorexia Nervosa clinical trials

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NCT ID: NCT04786951 Completed - Anorexia Nervosa Clinical Trials

Virtual Reality-Based Attention Bias Modification Training for Anorexia Nervosa (AN-VR-ABM)

Start date: December 21, 2021
Phase: N/A
Study type: Interventional

Anorexia Nervosa (AN) is considered as one of the most severe subtypes of eating disorders (ED), with important medical complications, high mortality rates, and high comorbidity with other disorders, such as anxiety disorders. Likewise, to what happens in anxiety disorders, several studies have suggested the presence of dysfunctional body-related Attentional Bias (AB) in patients with ED and, specifically, in AN patients. Patients with AN tend to focus their attention on their body, in a dysfunctional way, by showing body checking behaviors, and scrutinizing their general appearance and weight-related body parts. This body-related AB has been associated with higher levels of body dissatisfaction, one of the most important risk factors for the development and maintenance of ED. In addition, body-related AB may be responsible for decreasing the effectiveness of body exposure-based treatments used in patients with AN. For this reason, it is necessary to develop new treatment techniques by adding specific components that aim to reduce body-related AB. It has been proposed to include AB modification techniques within the body exposure therapy, as an effective treatment to reduce body-related AB, body dissatisfaction, and body anxiety. To date, our group has been the first, to use a combination of virtual reality (VR) and eye-tracking (ET) techniques to assess the presence of a body-related AB in non-clinical samples. In order to improve AN-based treatments, this project aims to develop a new AB modification procedure, using ET and VR technologies. In addition, this project aims to integrate this AB modification procedure as a part of a body exposure-based treatment that aims to reduce the fear of weight gain experienced by patients with AN. Finally, this project aims to assess whether adding two separate components of body exposure-based therapy and AB modification training would result in a more effective intervention. It is expected that adding a specific component of VR body exposure procedure in the usual treatment for AN, enhanced through the illusion of ownership toward the virtual body, will result in more effective treatment. In addition, it is expected that adding an AB modification training in the body-exposure-based procedure, will result in a further increase the effectiveness of the treatment.

NCT ID: NCT04779216 Active, not recruiting - Anorexia Nervosa Clinical Trials

Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa

Start date: September 20, 2021
Phase: Phase 3
Study type: Interventional

This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to investigate the effect of romosozumab on BMD in women with anorexia nervosa. The investigators will also investigate the safety of romosozumab in women with anorexia nervosa. The investigators hypothesize that 12 months of romosozumab administration will result in an increase in bone mineral density, increase in markers of bone formation and decrease in markers of bone resorption, and improvement in bone microarchitecture in osteopenic women with anorexia nervosa compared with placebo. The extension study will offer subjects 12-month administration of open-label alendronate (an oral bisphosphonate) 70 mg once weekly after the initial 12 month administration of romosozumab or placebo. The investigators hypothesize that 12 months of romosozumab followed by 12 months of open-label alendronate will result in a greater increase in BMD compared to 12 months of placebo followed by 12 months of open-label alendronate. Within the group of women who receive sequential therapy with 12 months of romosozumab followed by 12 months of alendronate, the investigators hypothesize that BMD will be maintained between 12 and 24 months while on alendronate.

NCT ID: NCT04770662 Completed - Anorexia Nervosa Clinical Trials

Obsessive-compulsive Symptoms in Children and Adolescents With Anorexia Nervosa

Start date: November 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to determine obsessive-compulsive symptoms and BMI changes in children and adolescents with anorexia nervosa and find out whether there is a group-level correlation between the two. We also investigate a possible link between obsessive compulsive symptoms and the psychological features of eating disorders. It is a national, academic, interventional study. The data will be acquired through questionnaires.

NCT ID: NCT04714541 Completed - Anorexia Nervosa Clinical Trials

Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

Start date: April 12, 2021
Phase: Phase 1
Study type: Interventional

This Open-Label Pilot Study Aims to Determine Whether a Two-Part Sequenced Out Patient Procedure Utilizing a Modified Ketogenic Diet Followed by a Series of Titrated Ketamine Infusions Results in Improvement or Remission of Chronic Anorexia Nervosa in Adults with Symptoms of Anorexia for at Least 3 Years Despite Treatment Involving at Least 2 Different Modalities. The Hypothesis is That the Diet Addresses Core Metabolic Deficits in the "Anorexic Brain" and Primes the Response to Ketamine.

NCT ID: NCT04678843 Completed - Anorexia Nervosa Clinical Trials

Adapting and Adopting Highly Specialized Pediatric Eating Disorder Treatment to Virtual Care: Implementation Research for the COVID-19 Context and Beyond

vFBT
Start date: February 9, 2021
Phase: Early Phase 1
Study type: Interventional

The COVID-19 pandemic has had detrimental effects on mental health. Individuals with eating disorders (EDs) are no exception, exhibiting increased symptoms and exacerbated feelings of isolation and anxiety. Across Canada, in-person outpatient services have been quickly replaced with virtual care, yet practitioners and patients have noted substantial challenges in adapting ED-related care virtually. Given the success of our previous research on Family-Based Treatment (FBT) for EDs, as well as the rapid transition to virtual care during COVID-19, there is an urgent need to adapt FBT to virtual formats and adopt it in the ED network. Using a multi-site case study with a mixed method pre/post design, this study aims to examine the implementation of virtual FBT (vFBT) as well as its impact within six ED programs in Ontario, building on the investigator's previous work, and further developing capacity in the system. The investigator will develop implementation teams at each site and provide a virtual training workshop on vFBT, with ongoing consultation during initial implementation. The investigator proposes to examine implementation success by studying fidelity to vFBT, as well as team and patient/family experience with virtual care, and patient outcomes. These findings for virtual care will not only be important in the COVID-19 context but are also vital in the North, where access to specialized services is extremely limited.

NCT ID: NCT04666415 Recruiting - Anorexia Nervosa Clinical Trials

Impact of the Addition of a Specific and Personalized Body Approach by Osteopathic Treatment in the Care of Adolescents With Anorexia Nervosa.

ACAMTO
Start date: February 6, 2020
Phase: N/A
Study type: Interventional

Abstract: Background: Anorexia nervosa (AN) is a common pathology affecting mainly women (sex ratio 1/10), which starts most often during adolescence. The prognosis of the AN remains poor (10% of deaths and high risk of chronicity). Body dissatisfaction, disturbances in recognition and identification of body sensations are some of the key symptoms of AN. There is, however, a contrast between this consensual observation of the importance of troubles in body image in AN, and the relative deficit of specifically targeted body treatments. Our proposal for a body approach specifically dedicated to AN is based on the understanding that posture, breathing, muscle tension and body perception are closely linked to our psychological and emotional state, and are therefore disturbed in patients with AN. The purpose of this monocentric randomized controlled trial is to evaluate if a targeted osteopathic protocol treatment for AN in addition to as-usual care is significantly more effective compared to as-usual care. Methods: Seventy-two female patients meeting the inclusion criteria will be randomly assigned to one of the two treatment groups : one receiving the specific osteopathic treatment targeted for AN in addition to the as-usual care (group A) and the other one, the as-usual care (group B). The patients of group A will receive 5 sessions of osteopathic treatment for 25 minutes. Soft specific palpatory techniques on the diaphragm, digestive system and cervical region will be realized. The as-usual care is defined by the multidisciplinary approach recommended by the high authority of health. The primary outcome is the evaluation of interoceptive sensibility and secondary outcomes include clinical and psychopathology-related symptoms and assessment of somatic dysfonctions' evolution. A qualitative study will also be carried out, applying the Interpretative Phenomenological Analysis method. Patients will be included for a maximum of 14 weeks between the inclusion time and the last evaluation. Discussion: If the results of the study are positive (statistically significant effectiveness of this body approach in addition to as-usual care compared to as-usual treatment), patients with anorexia will be benefit from the possibility of additional treatment that is effective, relatively inexpensive, non-invasive and non-pharmacological.

NCT ID: NCT04663919 Completed - Anorexia Nervosa Clinical Trials

Comparison of the Effects of Weight Changes on Serum Adipokines in Patients Diagnosed With Anorexia Nervosa and Morbid Obesity

Start date: January 1, 2014
Phase: N/A
Study type: Interventional

In this study, when patients diagnosed with AN started treatment and their weight increased by 10%; On the other hand, it was aimed to compare the changes in serum adipokine levels observed in morbidly obese patients before bariatric surgery and when they lost 10% of their post-op weight with both anthropometric measurements, biochemical parameters, and values of healthy volunteers.

NCT ID: NCT04661514 Completed - Anorexia Nervosa Clinical Trials

Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy

Start date: May 1, 2021
Phase: Phase 2
Study type: Interventional

The primary aim of this study is to assess the safety and tolerability of one 25 mg dose of psilocybin in participants with anorexia nervosa based on adverse events (AEs), changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests. The secondary objectives are to explore the efficacy of a single 25 mg dose of psilocybin on eating disorder symptoms and behaviors, body image, anxiety, food related obsessions and rituals, and body weight.

NCT ID: NCT04626219 Completed - Anorexia Nervosa Clinical Trials

Neurobiology of Anorexia and Bulimia Nervosa

Start date: February 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate areas of the brain responsible for appetite regulation. More specifically, the investigators would like to study changes in brain activation, e.g., changes in blood flow and oxygen use of the brain, during two different states: Once when the participants are hungry, and once when the participants are not hungry. The aim is to find out more about the neurobiology of Anorexia and Bulimia Nervosa by comparing women who never had an eating disorder with women who have recovered from Anorexia or Bulimia Nervosa.

NCT ID: NCT04625959 Active, not recruiting - Bulimia Nervosa Clinical Trials

Optimizing Mindfulness and Acceptance Based Behavioral Treatment for Bulimia Nervosa and Binge Eating Disorder

Start date: June 5, 2020
Phase: N/A
Study type: Interventional

The current study will use a full factorial design to identify the independent and combined effects of four core MABT components when combined with standard behavioral treatment for BN and BED. The primary aim of the study will be to evaluate the independent efficacy of Mindful Awareness, Distress Tolerance, Emotion Modulation, and Values-Based Decision Making on eating pathology (at posttreatment and at 6 and 12-month follow-ups). Secondary aims will be (1) to test target engagement of each MABT component, i.e., to confirm that each treatment component impacts both the variable which it targets and self-regulation and that improvements in these are associated with improvements in outcomes and (2) to test the hypotheses that the efficacy of each component is moderated by related baseline deficits in self-regulation (e.g. individuals with worse distress tolerance at baseline are most likely to benefit from conditions that include the Distress Tolerance component). 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 components may partially depend on each other).