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NCT04174703
Compassion-focused therapy (CFT) seeks to lower shame and help people develop compassion for personal distress and shortcomings. There is increasing evidence to support the benefits of incorporating CFT-based interventions into the treatment of eating disorders (EDs). Building on the investigators' prior research, this study will examine the effects of a two-week CFT-based self-compassion letter-writing intervention on patients with eating disorders. Participants will be recruited from the wait-list of patients scheduled to begin treatment at the outpatient St. Joseph's Healthcare Hamilton Eating Disorders Program, and will be randomly assigned to the two-week letter-writing intervention or to a control group. Results will inform the integration of new empirically-derived interventions into ED treatments to improve the currently dismal rates of ED recovery.
NCT07319936
It is often difficult for people with eating disorders to get timely access to specialized treatment, as waitlists can be long. The present study examines whether or not providing educational materials by email could help individuals with eating disorders while they wait for specialized care. The investigators hypothesize that a low-intensity self-guided intervention will lead to a reduction in eating-disorder attitudes and cognitions, and an increase in motivation to change and body satisfaction. Sixty-two adults (primarily women) are randomly assigned to one of two groups while being on the waitlist for specialized eating-disorder services. One group receives weekly emails for four weeks with psychoeducational materials about eating disorders; the other group does not receive any materials. The content was adapted from a validated eating-disorder workbook developed by the Centre for Clinical Interventions in Australia and translated into French. Each week, as well as one week after the intervention period, all participants complete brief questionnaires assessing eating-disorder thoughts, body satisfaction, and readiness to make changes in eating behaviours. Participants who receive the materials also rate their level of satisfaction with the materials as well as how useful and engaging they find the content.
NCT06306586
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.
NCT07179068
Body image concerns have been linked to diverse mental health issues, including depression and disordered eating. Disordered eating can develop into clinically significant eating disorders, which are associated with serious negative impacts on psychological and physical well-being, and can adversely impact developmental trajectories in children and adolescents. Given limitations in the eating disorder intervention literature, it is important to invest in effective eating disorder prevention programs. Evidence suggests that children can recognize the existence of societal appearance ideals as early as age 3; thus, this study examines the acceptability and feasibility of a single-session, online, parent-focused intervention targeting predictors of body image disturbance in young children.
NCT04779216
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. In Phase 2, participants will receive a single infusion of open-label zoledronic acid (an intravenous bisphosphonate) 5 mg after the initial 12-month administration of romosozumab or placebo. The investigators hypothesize that 12 months of romosozumab followed by a single intravenous infusion of open-label zoledronic acid will result in a greater increase in BMD compared to 12 months of placebo followed by a single intravenous infusion of open-label zoledronic acid. Within the group of women who receive sequential therapy with 12 months of romosozumab followed by a single intravenous infusion of zoledronic acid, the investigators hypothesize BMD will be maintained between 12 and 24 months following administration of zoledronic acid.
NCT06659354
The investigators aim to conduct a feasibility randomized controlled trial (RCT) of an eating disorder prevention program (The Body Project, adapted for pregnancy) versus a health education control among pregnant individuals with histories of an ED. The investigators will test the feasibility, implementation outcomes, and its preliminary effectiveness in reducing the risk of elevated disordered eating and body dissatisfaction during pregnancy and postpartum.
NCT07178977
This randomized controlled trial will evaluate the effectiveness of a structured four-week psychoeducation program for parents of adolescents diagnosed with anorexia nervosa (AN). The program aims to improve parental coping and improve adolescent treatment outcomes. Seventy adolescents with AN (ages 11-19) and their parents will be recruited at the University Medical Centre Ljubljana, Slovenia. Families will be randomly assigned to either an intervention group, receiving immediate psychoeducation, or a waitlist control group, receiving the program after one month. The psychoeducation program consists of four weekly 90-minute sessions covering eating disorder characteristics, maintaining factors, strategies for normal eating, and approaches for supporting change. Primary outcomes include change in adolescent body mass index (BMI) from baseline to post-intervention and three-month follow-up. Secondary outcomes include adolescent symptoms of eating disorders, anxiety, and depression, as well as parental anxiety, depression, stress, social support, and self-efficacy. The study will test whether early, structured parental involvement through psychoeducation improves both adolescent clinical outcomes and parental coping.
NCT04815044
Women with the eating disorder bulimia nervosa (BN) have been found to have a higher risk of unplanned pregnancies than healthy women, and experience greater miscarriage, premature birth, birth complications, and postpartum depression. Other studies have found that women with eating disorders seem to find motivation to refrain from the eating disordered behavior for the sake of the fetus, but that it is highly different whether this gives sustained or only a temporary remission. Eating disorders are rarely detected in the primary health care service, nor during pregnancy or during follow-up in fertility clinics. Meeting a health care provider in the pregnancy care service who does not know about the eating disorder or who does not understand the disease well enough, can also make the management and experience of pregnancy and weight gain extra difficult. The aim of this study is to increase the knowledge on how women with a history of eating disorder experience their bodily changes, and how they experience the health service in pregnancy care and post-partum period.
NCT07131852
The goal of this observational study is to investigate the relationship between structural brain changes and psychiatric comorbidities in individuals diagnosed with eating disorders (EDs). The main question it aims to answer is: How are structural brain volumetric changes associated with psychiatric comorbidities in patients with eating disorders? Participants with a clinical diagnosis of an eating disorder will undergo brain MRI scans for volumetric analysis and structured psychiatric assessments to identify comorbid conditions. Data will be collected cross-sectionally from patients receiving routine clinical care, with the aim of identifying neurobiological and psychiatric patterns that could inform targeted treatment and prevention strategies.
NCT05539807
This prospective one-arm study aims to examine short and long-term changes in dysfunctional eating among individuals who signed up for an 8-week, group based, low threshold, mindfulness-based intervention. The study is an extension of a quality assurance project which was provided by a nation-wide self-help organization for people with self-identified eating problems. Eating disorder symptoms and the proposed predictors (self-kindness, self-judgment and mindfulness) were registered online at 12 measurement time points. In the current study we will invite the same participants to complete the same measures four years after the intervention.
NCT06359951
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.
NCT06602973
This pilot study is a first step in looking at the relationship between exercise and appetite in women with loss of control eating.
NCT05596799
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).
NCT06790030
The goal of this clinical trial is to contribute to the improvement of treatment for eating disorders, by identifying factors that might positively affect treatment outcome. The main questions it aims to answer are: 1. Do higher levels of self-efficacy positively predict a more positive treatment outcome? 2. Does self-efficacy in itself improve during treatment? 3. Do autonomous motivation, self-esteem and self-efficacy correlate? These factors will be measured in patients being treated for their eating disorders with Cognitive Behavior Therapy - Ten (CBT-T). Researchers will administer questionnaires at start, session four and end of treatment. Participants will: 1. Receive their treatment as usual. 2. fill in questionnaires at the start of treatment, session 4 and end of treatment.
NCT05605067
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.
NCT06537895
UK Eating Disorder services are facing unprecedented demand, with effective service delivery hampered by inadequate resources, fragmented services and variable care pathways. Individuals with eating disorders, families and clinicians all agree on the critical need to improve care pathways and treatment, leading to better outcomes. Eating disorders are serious, complex conditions influenced by a blend of biological, psychological, and environmental factors. The approach of this project is grounded in the "biopsychosocial" model. Recently, anorexia research confirms a genetic component, with biological, metabolic, and psychological mechanisms at play. Further biological research across eating disorders could allow a better understanding of the mechanisms underlying eating disorder development and better, more personalised treatments. This project will test the feasibility of establishing a UK-wide NHS research network spanning child and adult eating disorder services to enable a step change in the ability to conduct eating disorder research. It will help address fragmentation and facilitate novel biological, psychological, and social research collaborations. The data the investigators gather will be open to all researchers for data analyses, and the collaborations established will form a collaborative network to enable future clinical trials, experimental medicine and psychology. The study will be conducted at child and adult eating disorder services who opt to join the Network. Participants will be patients receiving treatment for an eating disorder at one of the participating services, and their parents/guardians if applicable. Participants will complete questionnaires and have blood and other physical tests as specified in the EDCRN dataset. The study will last until 29th October 2026 (the end of the current funding period) and/or when a participant is discharged from treatment, whichever is sooner. For participants discharged before the study ends, there will be an opportunity for patients to complete optional follow-up questionnaires on a periodic basis.
NCT05722470
The aim of the present study is to evaluate the prevalence of eating disorder among adolescents. Also, to evaluate psychiatric comorbidity, sleep problems, alexithymia and emotion dysregulation associated with patients had eating disorders. In addition, to identify possible risk factors associated with eating disorder among adolescents.
NCT06491069
the goal of this observational study is to Investigate and determine rate of occurrence and associated risk factors of depression , anxiety , eating disorder after bariatric surgery. participants will undergo psychometric tests.
NCT06488287
This research investigates the feasibility of undertaking a large, randomised control trial of transcranial direct current stimulation (tDCS) as a treatment modality for managing food cravings and emotional eating. This study explores how tDCS, a non-invasive brain stimulation technique, can influence brain activity and potentially impact appetite regulation, self-control, reward processing, and other factors related to weight management. All participants will receive 6 sessions of stimulation within three weeks. the investigators aim to implement a two-day interval between intervention sessions, providing participants with a two-day rest period between sessions. This scheduling approach is intended to mitigate potential side effects and promote participants' recovery.
NCT06345040
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.