Clinical Research Directory

The Role of Estrogen in the Neurobiology of Eating Disorders

This is a randomized, double blind, placebo-controlled study of the effects of transdermal estradiol versus placebo on cognitive flexibility, reward processing, and eating disorder pathology in hypoestrogenemic female adolescents and young adults (ages 14-35 years) with an eating disorder characterized by extreme dietary restriction and/or excessive exercise. Subjects will be randomized 1:1 to 12 weeks of transdermal estradiol with cyclic progesterone or placebo patches and cyclic placebo pills. Study visits include a screening visit to determine eligibility and visits at baseline, 8 weeks, and 12 weeks. Study procedures comprise behavioral, neuroimaging, and endocrine assessments.

Eating Disorders in Patients With IBD

Inflammatory bowel diseases (IBD) may influence eating habits and lead some patients to adopt restrictive dietary behaviours to control gastrointestinal symptoms. In some cases, these behaviours may become maladaptive and resemble eating disorders, including avoidant/restrictive food intake disorder (ARFID). This observational cross-sectional study assesses the prevalence of eating disorder risk and ARFID risk among adult patients with IBD. Participants complete validated questionnaires evaluating eating behaviours, nutritional status, and IBD-related disability. Clinical and demographic data are also collected.

Using Bilateral Stimulation (A Pre-existing Trauma Technique) After Eating to Reduce Anxiety in People Recovering From Eating Disorders

The goal of this clinical trial was to evaluate whether bilateral stimulation (BLS) could reduce anxiety and emotional distress after eating in people recovering from eating disorders in outpatient treatment with the primary researcher. The main question it aimed to answer were: Did bilateral stimulation reduce anxiety, depression, and/or eating disorder thoughts when used after eating a fear food? Researchers compared participants who received standard treatment alone to those who received standard treatment plus bilateral stimulation after meals to determine whether BLS reduced emotional distress and negative thoughts related to eating. Participants: * Completed surveys assessing anxiety, depression, and eating disorder symptoms at the beginning and end of 4 consecutive sessions (4-12 weeks in total depending on the frequency of client appointments). * Chose to participate in either a standard treatment group or an intervention group Participants in the intervention group also: * Ate 1 meal per week before or during session, including a "fear food" (defined as food avoided out of fear of what might happen, i.e., weight gain, vomiting, guilt/shame). * Completed brief questionnaires about their thoughts and feelings after eating * Participated in 3-5 minutes of bilateral stimulation (side-to-side tapping) guided by the researcher * Reported on changes in their thoughts and emotions following the intervention The intervention was delivered over 4 consecutive sessions alongside standard treatment.

Eating Disorder Dynamic Intervention

The goal of this study is to develop and test a digital program to help people with eating disorders in their everyday lives. The program uses brief surveys and sensor data collected by smartphones to understand when someone may be at higher risk for behaviors like restricting food, binge eating, or using unhealthy weight control behaviors.

Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns

The current study aims to explore the efficacy of a text message based safety behavior fading intervention compared to a progressive muscle relaxation intervention for appearance concerns.

MICBT for Non-underweight Adults With Eating Disorders

Eating disorders (ED) are severe but treatable conditions, but there are large margin for improvements in terms of efficacy and adherence. There is room to explore new treatment options who are either more capable to retain patients in therapy, more effective. Alternative their efficacy may match the ones of current available treatments but offer new options to ones that did not respond to available therapies. Here the investigators explored if a combination of CBT-focused plus Metacognitive Interpersonal Therapy (MIT) is an empirically supported therapy for personality disorders and could be a new viable treatment option for non-underweight ED. MIT targets some aspects of ED such as poor awareness of mental states and maladaptive interpersonal schemas that are not included in the transdiagnostic model underlying the most investigated empirically supported treatment for ED that is CBT-E. It is reasonable therefore that targeting these aspects of psychopathology can be a path to treatment adherence and effectiveness

Metacognitive Interpersonal Therapy Across Transdiagnostic Eating Disorders, Including Underweight

The goal of this clinical trial is to assess if Metacognitive Interpersonal Therapy for Eating Disorders (MIT-ED) is effective for treating various forms of Eating Disorders (ED) and reducing dropout rates. The trial will also evaluate its feasibility and outcomes in a patient group including also underweight participants. The main questions it aims to answer are: * Does MIT-ED improve eating disorder symptoms and reduce overall maintenance factors, as alexithymia, emotional dysregulation, maladaptive perfectionism, and self-esteem? * Is MIT-ED effective in reducing the severity of personality disorders and associated global psychiatric symptoms? * What are the dropout rates and adherence levels for patients receiving MIT-ED? Participants will: * Undergo an initial screening to confirm eligibility, including a comprehensive clinical interview and assessments based on inclusion and exclusion criteria for the study. * Receive up to 40 individual sessions of MIT-ED, each lasting 50-60 minutes, over a period of approximately 10-12 months. * Attend regular assessment focusing on eating disorder symptoms (Eating Disorder Examination Questionnaire, EDE-Q 6.0, and ED Interview, EDE), emotional dysregulation (Difficulties in Emotion Regulation Scale, DERS), alexithymia (Toronto Alexithymia Scale-20, TAS-20), and self-esteem (Rosenberg Self-Esteem Scale, RSES). Assessment will be conducted at baseline (before starting MIT-ED sessions), after 20 MIT-ED sessions (approximately after 5 months), post-treatment (approximately after 10 months), and at 3 months follow-up. A longer 12-months follow-up is planned. Researchers will evaluate the effectiveness of MIT-ED based on treatment adherence, symptom improvement, and the reduction of maintenance mechanisms associated with Eating Disorders. Positive results could support the design of a larger, controlled Randomized Clinical Trial (RCT).

PrevED MR. Improving Emotion Dysregulation Through Mixed Reality Based Dialectical Behavioral Therapy in Adolescents and Young Adults at Risk of Developing Eating Disorders.

The aim of this study is to evaluate the feasibility and preliminary effects of PrevED MR, a group-based preventive intervention for adolescents and young adults at risk of developing eating disorders. PrevED MR is based on dialectical behavior therapy skills and uses mixed reality and virtual reality activities to support emotion regulation, mindfulness, distress tolerance, and body-related acceptance. Participants will be randomly assigned to either the PrevED MR intervention group or a waiting-list control group. The intervention will be delivered over 6 weeks, with two sessions per week, for a total of 12 sessions. Assessments will be conducted at baseline and after the intervention to examine changes in eating disorder symptoms, body image acceptance, emotion regulation strategies, rumination, usability, sense of presence, cybersickness, satisfaction, and adherence.

Project HOME: Home-Based Treatment Options and Mechanisms for Eating Disorders

This randomized, controlled effectiveness trial will assess outcomes, implementation, and mechanisms of two psychological treatments for adolescent anorexia nervosa (AN) delivered in the home setting, in the context of community-based mental health. Adolescents with AN-spectrum disorders (n=50) and their caregivers will be randomly assigned to either family-based treatment or integrated family therapy delivered in the home. Caregivers and adolescents will provide data on weight, eating, and putative treatment mechanisms, including caregiver self-efficacy, adolescent distress, and generalizability of treatment skills. Treatment feasibility, acceptability, and appropriateness will be measured among providers and participating families. The proposed study has clear potential to advance scientific and clinical understanding of the real-world effectiveness of psychological treatments for AN, including whether adapting them for the home setting may improve accessibility and effects on treatment outcome

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).

Impact of a Mobile App-Based Waitlist Intervention on Readiness for Eating Disorder Treatment

The goal of this randomized controlled trial is to evaluate whether a mobile app-based motivational interviewing intervention (MI-Coach: ED) can improve motivation and readiness for treatment in adults with eating disorders who are currently on waitlists for provincially funded eating disorder services in British Columbia. The main questions it aims to answer are: * Does the use of MI-Coach: ED improve overall motivation, confidence, and readiness for treatment compared to treatment-as-usual (waitlist with no intervention)? * Does the app help mitigate declines in motivation over time among waitlisted individuals? Researchers will compare participants using the MI-Coach: ED app to a delayed treatment control group to assess differences in motivation, readiness for treatment, and associated clinical outcomes. Participants will: * Treatment group: Use the MI-Coach: ED app for four weeks, completing interactive modules focused on motivation and readiness for change, while also completing weekly brief assessments of motivation. * Delayed treatment group: Remain on the waitlist with no intervention for four weeks while completing weekly brief assessments of motivation. After this period, they will receive access to the MI-Coach: ED app and be integrated into the treatment group. * Complete pre-test and post-test questionnaires at 0, 4, 8, and 12 weeks assessing motivation, eating pathology, anxiety, and depressive symptoms. This study aims to inform evidence-based practices for reducing the adverse effects of long waitlist durations on individuals with eating disorders.

Guided Self Help for Eating Disorders Implementation Study

Eating disorders are amongst the most understudied illnesses affecting young women in Canada. Further, mortality rates are amongst the highest of all psychiatric illnesses. Despite their high prevalence and mortality rates, research into adolescent eating disorders is underfunded in Canada. In addition to the problem of research underfunding, healthcare system underfunding exists - creating long waiting lists and fragmented care for children and youth with eating disorders. More efficient treatments are urgently needed to reduce wait times and provide expedited care to adolescents on eating disorder waitlists. The current study aims to assess whether implementing a virtual parent-lead therapy, Guided Self Help Family-Based Therapy (GSH FBT) might alleviate wait times for eating disorder services and also reduce eating disorder symptomatology in young people with anorexia nervosa. This study also aims to determine the experiences of both families and medical teams of GSH FBT implementation as an intervention.

Comparing Neural Responses to Food Images in EDNOS Patients and Healthy Controls Using fMRI

Currently, there is not a robust, testable neural model available that sufficiently explains the development and maintenance of anorexia nervosa (AN) a severe, often fatal, adolescent-onset eating disorder. Using state of the art neuroimaging and neuropsychological techniques, our objective is to identify neural mechanisms in the adolescent brain underlying AN. This is of high clinical relevance in as much as it will provide a robust platform for a diagnostic battery so that physicians can identify those who are prone to develop AN at a very early stage of life. The aim of this research plan is: 1) To develop knowledge of cognitive dysfunction in adolescents who have recently been diagnosed with AN, with a battery of cognitive tests during a series of clinical visits. 2) To provide a scientific basis for our knowledge about how the brain of an adolescent with an eating disorder differs from that of a healthy adolescent, by conducting functional and structural magnetic resonance imaging on adolescent females with AN.

Study of the Impact on the Evolution of the Disease in the Medium Term of the Implementation of a System of Extended Follow-up by Telephone Interview of Patients With an Eating Disorder Organized by the Nurses of the Eating Disorder Referral Center

The referral center for eating disorders provides for a systematic many years follow-up of patients under care with an annual assessment at the center. The investigators have recently shown the frequency of relapse in the first 7 years after diagnosis, but the literature remains poor on this epidemiology and on the risk factors for relapse. The investigators would therefore like to extend this follow-up for an additional 3 years after remission with an annual telephone nursing interview for all cured patients.

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.

Facing Eating Disorder Fears for Anorexia Nervosa

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).

Treatment of Adolescent Anorexia Nervosa

VISAN is a naturalistic study of family based treatment of Anorexia nervosa in adolescnet girls.

Relationships Between Exercise and Appetite in Women With Loss of Control Eating

This pilot study is a first step in looking at the relationship between exercise and appetite in women with loss of control eating.

The STEP-MIED Trial: Digital Stepped-Care for Emotional Disorders

The goal of this clinical trial is to evaluate the effectiveness and cost-effectiveness of a digital mindfulness-based intervention in adults (aged 18-65) diagnosed with emotional disorders like depression or anxiety. The main questions it aims to answer are: * Does adding a digital mindfulness intervention to usual care help people recover from emotional disorders faster and more sustainably over two years? * Is this combined approach more cost-effective than usual care alone? Researchers will compare the group receiving the digital mindfulness intervention plus their usual treatment to the group receiving only their usual treatment to see if the intervention leads to better long-term recovery and represents good value for money. Participants in the intervention group will: * Attend eight weekly 2-hour online group mindfulness sessions. * Use a WeChat mini-program for 49 days of guided mindfulness exercises and daily tasks. * Patients who have not achieved reliable recovery after group retraining voluntarily participate in individual UP\&MIED counseling. * Complete regular questionnaires and interviews over two years to track their progress. All participants will continue to receive their usual medical care from their doctors throughout the study.

Developing an Artificial Intelligence (AI) Chatbot for Adolescents and Young Adults With Eating Disorders

The goal of this study is to develop and refine an artificial intelligence (AI)-powered Exposure Therapy for Eating Disorders chatbot web-app that effectively engages adolescents and young adults and decreases anxiety about weight gain. Participants will use the web-app as a supplemental therapeutic tool during their first six weeks of treatment in a Partial Hospitalization Program. Participants will complete assessments every two weeks, including: (1) semi-structured interviews about their experience with the chatbot web-app; (2) implementation outcome measures (e.g., feasibility, usability, acceptability); and (3) anxiety about weight gain.

Technology Exposure and Child Health: Wellness Impact and Social Effects: An Observational Product Registry Study

The goal of this study is to understand how children's mobile device usage (smartphones or tablets), including social media use and online games, are related to their mental wellness and mental health, as well as some aspects of their physical activity and sleep. This study is available to all children between the ages of 8 and 17 years and a parent/caregiver. Researchers will compare participant mobile device usage with their survey responses on sleep, stress, mental health, and physical activity, as well as their parent/caregiver's survey responses. Participants will: * run the Aura app with parental controls on their dedicated mobile device * complete monthly surveys * answer daily questions on mood, stress, sleep and physical activity The study is fully virtual. Duration is 3 months.

Impact of Peer Mentors on Individuals Transitioning to Adult Eating Disorder Treatment

Participants will be males and females aged 16-24 with an eating disorder (ED) diagnosis who are transitioning to adult-oriented ED treatment in Nova Scotia, New Brunswick, or Prince Edward Island. Youth participants will be recruited from community-based clinics, hospital programs, and private practices where ED treatment is delivered. Youth who are interested in participating and provide written consent will be invited to take part in a screening meeting to determine eligibility to participate. Eligible participants will be paired with a peer mentor for a 3-6 month intervention to guide them through the transition to adult-oriented ED treatment. Participants will be asked to complete questionnaire packages before beginning the intervention, after completing the intervention, and 12 months after beginning the intervention. Some youth participants, as well as some of their carers and the peer mentors, will be asked to participate in one-on-one interviews about their experiences with transitions in ED care and the peer mentor intervention. The investigators are conducting this study to determine whether the use of peer mentors is an effective and acceptable means of transition support for youth with EDs. The investigators are also interested in better understanding the experiences of carers and peer mentors who are supporting youth with EDs during their transition in care.

Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population

Electrocardiogram (ECG) Q-T prolongation is a cardiac electrophysiological disorder associated with the occurrence of arrhythmias potentially fatal. Several psychotropic drugs are associated with an increased risk of QT prolongation, which is why in clinical practice a baseline ECG is performed before a psychotropic drug is prescribed. However, there are no validated protocols establishing when to repeat this examination or describing clinical events when this examination should be repeated in clinical follow-up. The study aims to investigate the incidence of QTc prolongation events as a side effect of chronic psychotropic drug administration. For this purpose, ECGs will be recorded and confounding factors of patients at the beginning of psychotropic therapy and after 3, 6 and 12 months will be analyzed.

Lifestyle Intervention for Obesity and Eating Disorder Prevention in Transgender Adolescents

Transgender and gender-diverse adolescents are at increased risk for obesity, disordered eating behaviors, body dissatisfaction, and reduced quality of life due to minority stress and structural inequities. However, no structured lifestyle interventions specifically tailored to this population have been developed. This randomized controlled trial aims to evaluate the effectiveness of a 6-month interdisciplinary lifestyle intervention designed to prevent obesity and eating disorders in transgender and gender-diverse adolescents aged 10-14 years. Participants will be randomized (1:1) to either an intervention group receiving monthly group sessions (for adolescents and caregivers separately) and weekly supportive messages, or a control group receiving standard outpatient care and general health recommendations. The primary outcome is quality of life measured by the WHOQOL-BREF. Secondary outcomes include eating disorder symptoms, body image, diet quality, physical activity levels, sedentary behavior, body composition, and anthropometric measures.