Clinical Research Directory

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.

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.

Diabetes Body Project 2

The purpose of this study is to test the feasibility and effectiveness of an eating disorder prevention program specifically targeted for women with type 2 diabetes (T2D) called the Diabetes Body Project 2 (DBP2). The Diabetes Body Project 2 (DBP2) will be adapted from the Diabetes Body Project, which is an eating disorder prevention program developed to improve satisfaction with body image and diabetes management for young women with type 1 diabetes (DBP). The study is looking to see if the DBP is effective in improving body image concerns, reducing disordered eating behaviors and improving glycemic control in women with T2D.

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.

Neurostimulation Versus Therapy for Problems With Emotions

The primary goal of this clinical trial is to evaluate the unique neural and behavioral effects of a one-session training combining emotion regulation skills training, with excitatory repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC). The secondary aim is to identify key changes in the emotion regulation neural network following the combined intervention versus each of the components alone. The third aim is to explore personalized biomarkers for response to emotion regulation training. Participants will undergo brain imaging while engaging in an emotional regulation task. Participants will be randomly assigned to learn one of two emotion regulation skills. Participants will be reminded of recent stressors and will undergo different types of neurostimulation, targeted using fMRI (functional MRI) results. Participants who may practice their emotion regulation skills during neurostimulation in a one-time session. Following this training, participants will undergo another fMRI and an exit interview to assess for immediate neural and behavioral changes. Measures of emotion regulation will be assessed at a one week and a one month follow up visit.

Disordered Eating and Recurrent Weight Gain After MBS

Obesity represents an increasingly serious public health problem worldwide. According to the World Health Organization, one in eight individuals globally is affected by obesity. Bariatric surgery (BS) is recognized as the most effective treatment for severe obesity and has been shown to significantly improve obesity-related comorbidities. However, despite initially successful surgical outcomes, a substantial proportion of patients experience insufficient weight loss (IWL) or weight regain (WR) after surgery. Previous studies have identified multiple factors associated with post-bariatric IWL and WR, including older age, low socioeconomic status, higher baseline body mass index (particularly preoperative BMI \>50 kg/m²), type of surgical procedure, hormonal mechanisms, poor adherence to postoperative dietary recommendations, maladaptive eating behaviors, insufficient physical activity, and the presence of psychiatric comorbidities. Among these, behavioral factors appear to play a particularly critical role. Irregular eating patterns such as loss of control eating, maladaptive behaviors such as grazing, non-adherence to dietary guidelines, and a return to preoperative eating habits are frequently associated with weight regain. Additionally, physiological mechanisms, including increased appetite, food cravings, and altered hormonal regulation of energy intake, may further contribute to this process. Grazing behavior-defined as repetitive consumption of small amounts of food accompanied by a sense of loss of control-has been consistently associated with poorer weight outcomes after bariatric surgery. A large meta-analysis reported grazing prevalence rates between 16.6% and 46.6%, with weight regain observed in nearly half of post-bariatric patients. Moreover, lack of structured nutritional follow-up has been shown to significantly increase the risk of weight regain. Neurobehavioral changes also occur after surgery: while appetite and responsiveness to palatable foods typically decrease during the first postoperative year, these effects often diminish over time, with hunger, cravings, and portion sizes gradually increasing in some individuals. Long-term weight regain has been closely linked to disordered eating behaviors, including emotional eating, binge eating, compulsive eating, food addiction, and loss of control eating. Recent studies have demonstrated significant associations between weight regain and binge eating disorder, eating disinhibition, and impulsivity. Qualitative research further highlights that many patients struggle to manage emotional eating and require ongoing psychological and dietary support following surgery. Despite growing evidence emphasizing the behavioral and psychological components of post-bariatric outcomes, comprehensive studies that simultaneously evaluate nutritional status, eating disorders, and emotional factors in individuals experiencing IWL or WR remain limited. Therefore, the present study aims to assess nutritional status, eating disorder symptoms, and emotional factors in individuals who experience insufficient weight loss or weight regain after bariatric surgery. By integrating anthropometric, nutritional, behavioral, and emotional assessments within the same sample, this study seeks to provide a multidimensional perspective and contribute to the development of more effective multidisciplinary follow-up and psychodietetic interventions.

Study Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and a Waitlist Control for Eating Disorders in Type 1 Diabetes

The goal of this clinical trial is to test whether a new intervention works to treat eating disorders in type 1 diabetes. Participants are assigned to one of the following: (1) Acceptance and Commitment Therapy (ACT), (2) Supportive Diabetes Counseling, or (3) a 6-month Waitlist Control. Participants in the ACT and Supportive Diabetes Counseling conditions complete 12 sessions over 12-16 weeks and use their mobile phone between sessions to increase engagement and reinforce learning. The main questions are: Does treatment improve glycemic levels, eating disorder symptoms, diabetes management and diabetes distress? Does one treatment do better than the other? How do the treatments work, if they work, and for whom? Participants complete assessments that include wearing a continuous glucose sensor and activity watch, and get a blood draw to determine HbA1c. They also complete diagnostic interviews, surveys and computer tests of attention and things like heart rate and reaction time. These assessments help us better understand the types of changes that are happening and how they might influence health and well-being.

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.

Cognitive-Behavioral and Digital Therapy for Suicide Risk in Eating Disorders

The purpose of this study is to determine if adding a digital intervention to standard cognitive-behavioral therapy (CBT) is more effective in preventing suicide risk and reducing eating disorder symptoms. Participants will be women between 18 and 65 years old who have recently experienced suicidal ideation or attempts. One group will receive standard group therapy, while the other will receive group therapy plus a mobile application and digital monitoring devices. The goal is to see if digital tools can improve clinical outcomes and safety for patients.

Study of the Effectiveness of a Systematic Minimal Early Intervention on Care Engagement in Adults With Eating Disorders Requesting Specialized Treatment.

Eating disorders (EDs) are complex psychiatric conditions-such as anorexia nervosa and bulimia nervosa-often emerging in young adulthood and associated with high morbidity and mortality. Despite their severity, access to specialized care remains difficult, delayed by shame, stigma, and a lack of insight among patients, as well as long waiting times and limited specialized resources. The AGIS-TCA pilot study aims to evaluate the effectiveness of a systematic minimal early intervention designed to reduce the number of patients lost to follow-up between their request for specialized care and the actual start of treatment. This monocentric, low-risk interventional study will be conducted at the Clinique des Maladies Mentales et de l'Encéphale (CMME), GHU Paris Psychiatrie \& Neurosciences. The intervention includes three early, structured telephone calls and five online support group sessions offered during the waiting period for care. The main objective is to determine whether this proactive approach decreases attrition rates ("lost to follow-up") compared with a historical cohort. Secondary objectives include assessing the acceptability of early phone contact, adherence to support groups, and describing the clinical and sociodemographic profiles of patients requesting care or lost to follow-up. The expected benefit is to facilitate timely access to care for vulnerable patients, prevent symptom worsening, and strengthen engagement in treatment pathways. Risks and constraints are minimal, as participation involves only remote interactions without any invasive procedures.

Targeting Transdiagnostic Self-regulatory Factors and Eating Disorder Pathology Among Adults With BInge-spectrum Eating disOrders: A mHEALTH Interoceptive Exposure Intervention (the Bio-HEALTH Study)

The present study will be fully remote (virtual) and include observational design features (assessments) plus a clinical trial. All assessments will be completed using HIPAA-approved platforms (e.g., Qualtrics, MindLogger EMA platform). After screening via Qualtrics to determine eligibility (described below), participants will complete a cross-sectional survey via Qualtrics, followed by a baseline EMA period. During the baseline EMA period, participants will receive brief (3-5 minutes) surveys on their mobile devices 6 times per day for 7-days via the MindLogger app. During the baseline EMA period, participants will also be asked to wear non-invasive chest-worn Holter monitors (Polar H10 Holter monitors) that will capture their heartrate variability data. They will then complete the 4-week intervention (HRV bio or ED-JITAI treatment arms; see below), followed by a post-intervention 7-day EMA assessment period while they also wear the Holter monitors. Recruitment is expected to last for 1.5 years. In HRV-bio, participants will also complete a HRV biofeedback task via the Elite HRV app. In this intervention, participants will learn how to use their HRV data that they will see in real-time via the Elite HRV app to improve their HRV by engaging in an app-guided diaphragmatic breathing exercise. They will complete this exercise twice daily (morning, night). In ED-JITAI, participants will be prompted to complete focused, guided body scan tasks that will be sent to them via the MindLogger app. These guided tasks will be sent to them in the form of 1 of 3 brief (3-5 minute) videos via the MindLogger app. The body scans will be designed to promote participants' connection with, vs. distancing/distraction from, feared ED sensations (e.g., hunger, satiety, bloating). Participants will receive prompts to complete the body scans at times when they report via EMA that they are experiencing worse interoception than usual. "Worse interoception than usual" will be defined as participants' EMA-reported interoception scores during the intervention period that fall 1 SD or more above their baseline EMA-reported interoception levels.

A Study to Evaluate Primary Care Treatment for Adolescent Eating Disorders

The purpose of this study is to test the feasibility of a RCT of a new treatment for children and adolescents with eating disorders characterized by dietary restriction and/or weight loss or failure to gain expected weight. The treatment, which is called Family-Based Treatment for Primary Care (or FBT-PC for short), is based on Family-Based Treatment, the gold standard outpatient eating disorder treatment for children and adolescents.

A Brief Cannabis Use Psychoeducation Intervention for Eating Disorder Patients

The goal of this clinical trial is to learn if providing eating disorder patients with education about the consequences of cannabis (marijuana) use on mental health, gastrointestinal symptoms, eating disorder symptoms, and eating disorder treatment effectiveness increases their knowledge about the cannabis use consequences, intention to reduce cannabis use, and motivation to seek treatment for their cannabis use. The main questions this study aims to answer are: 1. Does education about consequences of cannabis use increase eating disorder patients' knowledge about the risks of cannabis use? 2. Does education about the consequences of cannabis use increase intention to reduce cannabis use and seek cannabis use treatment among those with eating disorders? 3. Does cannabis use interfere with how successful eating disorder treatment is for eating disorder patients? All participants will receive 20 weeks of eating disorder treatment. In week 1 of treatment, participants will either be assigned to receive education about cannabis use consequences, or be assigned to a control condition where they receive education about consequences of poor sleep. Participants will be asked to complete a number of questionnaires that measure knowledge about cannabis use consequences, intention to reduce use and seek cannabis use treatment, eating disorder symptoms, and cannabis use habits. Researchers will assess how effective providing education about cannabis use consequences is on changing knowledge about cannabis use risks, intention to reduce use, and intention to seek cannabis use treatment. It will also be examined if effectiveness of eating disorder treatment is related to cannabis use habits.

Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing

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.

Inpatient Care of Patients With Difficult to Treat Anorexia Nervosa - Factors Affecting Treatment Outcome.

The overall aim of the project is to investigate factors that may influence treatment outcomes in people with difficult-to-treat anorexia nervosa who are enrolled in inpatient care at the Region Skåne Eating Disorders Centre in Lund. Treatment expectations, sense of autonomy, and patient participation, will be investigated, as well as caregivers' attitudes towards, and experiences of working with, autonomy and patient participation in the inpatient setting. The research project is expected to contribute to increased knowledge about the treatment of difficult-to-treat anorexia nervosa, and what part patient participation and autonomy may play when treating severe eating disorders. The overall objectives of the research program are: 1. To contribute to increased knowledge about factors that influence the treatment of people with difficult-to-treat anorexia nervosa 2. To highlight the role of autonomy and patient participation in inpatient care of severe eating disorders 3. To use the research results for clinical improvement work at Region Skåne Eating Disorders Center

Overview of Knowledge and Practices Among Healthcare Professionals Treating Eating Disorders

Perinatal psychiatry is a psychiatric specialty that has been developing for several years. This perinatal period is crucial for bio-psycho-affective development. Eating disorders are among the most common disorders in psychiatry. Women who have experienced or currently experience eating disorders may exhibit a relapse, stabilization, or improvement in these behaviors, with direct consequences for their baby's development. Although eating disorders have been extensively studied in adolescents and adults, the perinatal period remains less explored.

Detection of Eating Disorders in Pregnant Women

Eating disorders (ED) are insufficiently detected and belatedly or not treated during pregnancy. There are many screening questionnaires for eating disorders in the literature, but we note the absence of a specific and validated tool for their screening during pregnancy, which would make it possible to differentiate maternal dietary concerns related to pregnancy from symptoms linked to a proven eating disorder. The main objective of the study is to evaluate which items of the Sick Control One stone Fat Food (SCOFF-F) and Eating disorders examination questionnaire (EDE-Q) questionnaires could be specific to an ED during pregnancy and not related to the simple state of pregnancy, by comparing the answers of pregnant women, for whom the diagnosis of ED has been made, to those of pregnant women without an ED.

A Digital Treatment for Adolescents With Eating Disorders

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.

Oral Indicators for ED Screening

The main objective of this research project is to explore the capability of a standardized, evidence-based study tool (the OHEDs Checklist) in the early identification of oro-dental manifestations potentially indicative of an eating disorder. The secondary objective is to evaluate the sensitivity and specificity of the OHEDs Checklist in comparison with validated screening instruments for eating disorders, namely the ESP, SCOFF and DEQ questionnaires.

Sleep and Activity For Eating Disorders

The SAFE (i.e., Sleep and Activity For Eating disorders) study aims to investigate the characteristics of sleep, daytime activity, and circadian rhythms in a sample of patients with eating disorders-specifically anorexia nervosa, bulimia nervosa, and binge-eating disorder-as well as the relationship between these variables and physiological parameters (i.e., body mass index, hormone levels, blood chemistry parameters) and psychological parameters (i.e., levels of depression and anxiety, body image, eating-disorder symptoms).

Acceptability and Feasibility of a Single-Session Online Parent-Focused Intervention Targeting Child Body Image Development

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.

Virtual Body Project Groups Led by Peers Versus Clinicians

Eating disorders (EDs) are a group of illnesses associated with significant psychological and physiological consequences. Overall, only 20% of individuals with EDs receive treatment and treatment is effective for only about 25-35% for those who receive care. The development and implementation of effective prevention approaches for those at risk is therefore pivotal. The Body Project is the most effective ED prevention program for at-risk females according to meta-analyses, but reach has been limited since delivery has traditionally been in-person. Further research is warranted to examine cost-effective and easily accessible approaches to increase scalability and potential for broad implementation. With this application, the investigators therefore propose to examine the effectiveness of the Body Project in young females, a high-risk group, with the following main novel aspects: i) virtually-delivered Body Project groups to maximize reach; ii) peer-led versus clinician-led virtually-delivered Body Project groups; iii) the inclusion of objective measures to assess engagement of intervention targets (i.e., mediator).

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