Clinical Research Directory

Development, Implementation, and Evaluation of the HADAS Program for the Prevention of Eating Disorders in Adolescent Female Athletes, Coaches, and Families.

Adolescent female athletes in aesthetic sports disciplines (such as rhythmic gymnastics, artistic gymnastics, synchronized swimming, and figure skating) face a complex interaction between general sociocultural beauty pressures and sport-specific aesthetic demands (e.g., the 'slim to win' culture and weight-focused performance expectations). These combined pressures significantly increase their risk of developing body dissatisfaction and eating disorders (EDs). To address these systemic vulnerabilities, the HADAS Program (Habits, Eating, Sports, Adolescents, and Health) was developed as a multi-level, synchronized psychoeducational intervention designed to target the complete "sports triangle": adolescent female athletes, their technical coaches, and their immediate family members. The primary objective of this cluster randomized controlled trial (cluster RCT) is to evaluate the efficacy of the HADAS Program in reducing eating disorder risk (EAT-26) and body image dissatisfaction (BSQ-34) among competitive adolescent female athletes aged 12 to 16 years. Sports clubs are randomly assigned to either the Experimental Group (receiving the HADAS intervention) or a Waitlist Control Group (maintaining standard training). The program includes 5 interactive group sessions for athletes, 4 reflective workshops for coaches, and 2 structured sessions for family members, all supported by cohort-specific workbooks. Outcomes are evaluated across four longitudinal time points: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).

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.

Exploratory Study of Sensory Profile and Coping Strategies in Eating Disorders

This descriptive study aims primarily to characterize the sensory profile of patients with eating disorders (divided into three diagnostic groups: anorexia nervosa, boulimia nervosa and hyperphagia), controlling for possible autistic traits in this population. The study involves measuring characteristics associated with eating disorders (diagnosis, BMI, anxiety), assessing the sensory profile (AASP), and coping strategies in patients with eating disorders who are hospitalised or followed up in consultation.

Evaluation of National Highly Specialized Care for Children and Adolescents With Severe Self-Harm or Eating Disorders

National Highly Specialized Care (NHV) is provided in Sweden to children and adolescents with severe and treatment-resistant self-harm or eating disorders when previous treatment has not led to sufficient improvement. NHV offers intensive, individualized care delivered by multidisciplinary teams with specialized expertise. This observational study aims to evaluate NHV provided at two specialized psychiatric services in Region Stockholm: Child and Adolescent Psychiatry Stockholm (BUP Stockholm), for severe self-harm, and the Stockholm Centre for Eating Disorders (SCÄ), for children with severe eating disorders. The primary aim is to explore patients' and their parents' or legal guardians' experiences of NHV and their perceptions of its effects through qualitative interviews conducted at treatment completion and one year later. Secondary aims are to evaluate treatment feasibility, adherence, and changes in psychiatric symptoms, functioning, and skills during and after treatment. Data are collected through questionnaires completed by patients and their parents or legal guardians, clinical assessments, and medical records. Assessments are conducted 1) at baseline, which is defined as the first treatment week, 2) after six weeks of treatment, 3) at regular treatment completion (approximately 12-13 weeks), 4) if the treatment is extended by 4-6 weeks due to, for example, severe comorbidity, an additional assessment is conducted at the end of this treatment extension, 5) at six-month follow-up, and 6) at twelve-month follow-up after treatment completion. The study aims to improve understanding of the benefits and limitations of NHV and contribute to the further development of specialized psychiatric care for children and adolescents with complex treatment needs.

Expand Your Horizon-Spanish

The goal of this clinical trial is to evaluate whether Expand Your Horizon (EYH), a brief writing intervention focused on body functionality, can improve body image in university students aged 18 to 30 years in Spain and Argentina. The main questions it aims to answer are: Does EYH improve body appreciation and appreciation of body functionality compared with an active control condition? Are changes in body image flexibility, self-compassion, and mentalization potential mechanisms underlying improvements in body image? Researchers will compare EYH with an active control program involving creative writing exercises to evaluate the effects of the intervention. Participants will: Complete online questionnaires before the intervention, immediately after it, and one month later. Complete three writing exercises over approximately five days. Participants in the EYH group will write about their body's functions and their personal meaning, while those in the control group will complete creative writing exercises. Answer questions about their experience of the intervention, including satisfaction and acceptability. Have their written responses to the EYH exercises analyzed qualitatively to explore how they describe and understand their bodies and body functionality.

Evaluation of National Highly Specialized Care for Adults With Treatment-Resistant Self-Harm and Eating Disorders: Substudy 1

This study aims to evaluate National Highly Specialized Care (NHV) for adults with severe and treatment-resistant self-harm or eating disorders in Sweden. The study examines patients' and their significant others' experiences of care, the feasibility of the treatment programs, and changes in patients' symptoms and functioning during and after treatment. Participants receive specialized inpatient care or a combination of inpatient and intensive outpatient treatment, based on their individual clinical needs. Treatment typically lasts approximately 12 weeks but may vary depending on the patient's circumstances. Additional interventions may be provided to address co-occurring psychiatric conditions. Information is collected through self-report questionnaires, qualitative interviews, and clinical records. Patients and their significant others are invited to complete assessments during treatment and at follow-up, including up to five years after treatment. The findings are expected to contribute to improving specialized care for people with severe self-harm and eating disorders.

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.

Mealtime Anxiety in Eating Disorders

The goal of this observational study is to assess mealtime anxiety in patients with eating disorders receiving treatment at an in-patient unit. Anxiety wil be assessed using ecological momentary assessment (EMA). The main research question is: • Does post meal activity reduce anxiety in patients with eating disorders? Study participation will last for two weeks. Participants will be reporting current levels of anxiety/distress on an EMA mobile app during treatment as usual. During one of the two study participation weeks, the participants will perform post mealtime activity.

Preventing Disordered Eating and Body Dissatisfaction Among High-risk Pregnant Individuals

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.

Naltrexone Neuroimaging in Teens With Eating Disorders

Using a randomized, placebo-controlled, crossover study, this study will evaluate functional magnetic resonance imaging (fMRI) as a pharmacodynamic biomarker of opioid antagonism in adolescents with eating disorders. The hypothesis is that fMRI will be able to detect acute reward pathway modulation by naltrexone (an opioid antagonist) in pre-defined regions of interest (anterior cingulate cortex, nucleus accumbens, dorsolateral prefrontal cortex).

Triggers of Eating Disorders in Athletes

Over the past 30 years, a high prevalence of eating disorders in sports has been repeatedly documented, yet few preventive measures have been implemented. While most studies explore risk factors through quantitative means, few have investigated how athletes themselves experience the triggering elements in sports and how they perceive these triggers could be better managed. Another persistent question is why some athletes from a given sport and environment develop eating disorders while others do not. This study explore the experienced triggers reported by athletes who have struggled with eating disorders and compare them to the perspectives of athletes without eating disorders from the same environment. The study also aim to gather perceptions from both groups on how eating disorders and body dissatisfaction could be better addressed and prevented in sports.

FlexED: National Substudy

The purpose of this study is to test the feasibility of disseminating an intervention broadly. "FlexED" is a digital gamified intervention targeting eating disorder symptoms in young women and girls at risk by changing how they experience thoughts and feelings about their body. The digital intervention is based on Acceptance and Commitment Therapy (ACT). Participants complete seven 20-minute sessions of the intervention using their smartphone over about 8 weeks. Participants also complete questionnaires bi-weekly as they go through the intervention. A final measurement is taken one month after the last digital intervention session. These surveys are all conducted online. Participants are in the study for up to 12 weeks.

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.

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.

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).

Open vs. Blind Weighing Study In Adolescents and Young Adult With Eating Disorders

Current treatments for adolescents and young adults (AYAs) with eating disorders (EDs) do not effectively address a central ED symptom - anxiety about weight gain - which contributes to poor outcomes. The proposed study evaluates the feasibility, acceptability, efficacy, and underlying mechanisms of an enhanced version of "open weighing," a cognitive-behavioral intervention designed to target anxiety about weight gain in AYAs with EDs. Understanding how to better treat AYAs with EDs, and identifying the mechanisms by which interventions lead to improvement, will aid in the development of more effective and personalized treatments, ultimately improving the lives of AYAs with EDs.

FlexED: A Digital, Gamified Early Intervention for Eating Disorders

The goal of this clinical trial is to test a new intervention for body-image distress to reduce eating disorder symptoms in young women and girls between the ages of 15-25 years old. Participants complete up to 8 digital sessions using their mobile phone that include a character, story line and interactive exercises, games and digital rewards. Everyone in the study completes the intervention after different periods of time (2, 4 or 6 weeks) of completing assessments. Researchers will examine the impact of the intervention on participants ability to respond flexibly to body-image distress or triggers, measuring things like heart rate, eye gaze, and reaction time to body-image related words and images, and test how long it takes to see change.

Biobehavioral Mechanisms of Activity and Loss of Control Eating in Children

Loss of control eating in children and adolescents is associated with a host of negative physical and psychological health outcomes and a prognostic marker for development of eating disorders. However, there is a lack of longitudinal research investigating the developmental processes contributing to loss of control eating in youth. While physical activity, sedentary behavior, and self-regulation have been linked to the regulation of eating, no research has examined the mechanistic processes by which these domains may together impact loss of control eating during childhood and adolescence. Furthermore, given that these factors (i.e., activity, self-regulation, and eating behavior) vary considerably from moment-to-moment, it is imperative to utilize methodology that can capture momentary, real-time fluctuations in these domains. Therefore, the current study proposes to use a biobehavioral, multi-method approach integrating neuroimaging, accelerometry, neurocognitive assessments, and ecological momentary assessment (EMA) to study how physical activity and sedentary behavior patterns and self-regulation influence loss of control eating and related eating disorder psychopathology from late childhood to adolescence, which is a critical transitional developmental period. Male and female children aged 10-12 at baseline (N=200) will be recruited to complete annual assessments for 3 years. Aim 1 (momentary) - Examine momentary associations between physical activity patterns, self-regulatory mechanisms (i.e., inhibitory control, emotion functioning, and food-related reward anticipation) and loss of control eating in daily life using multi-method ambulatory assessment. Hypothesis 1a: Momentary decreases in physical activity and increases in sedentary behavior, compared to one's usual level, will be associated with increases in loss of control eating. Hypothesis 1b: Momentary decreases in self-regulatory mechanisms (i.e., decreases in inhibitory control, emotion regulation, and positive affect, and increases in negative affect and food-related reward anticipation) will explain (i.e., mediate) associations between decreases in physical activity/increases in sedentary behavior and subsequent increases in loss of control eating. Aim 2 (longitudinal) - Examine longitudinal associations between physical activity patterns, self-regulatory mechanisms, and binge eating and related eating pathology (i.e., loss of control eating, binge episodes, eating disorder onset, global eating psychopathology) using multimethod ambulatory assessment and functional magnetic resonance imaging (fMRI). Hypothesis 2: Across a three-year follow-up, children who show greater decreases in physical activity and increases in sedentary behavior, compared to other children, will demonstrate greater decreases in self-regulatory capacity (i.e., decreases in inhibitory control, emotion regulation, and positive affect, and increases in negative affect and food-related reward anticipation), which in turn will predict increases in binge eating and related eating pathology by year three. The hypothesis will be evaluated using self-regulation indices measured via EMA (Hypothesis 2a) and via task-evoked neural activations during fMRI (Hypothesis 2b).

Eating Disorder Prevention Program for Women With T1D

This study aims to test the effectiveness of an evidence-based eating- disorder prevention program specifically targeted for individuals with Type 1 Diabetes (T1D) compared to an educational control group. The Diabetes Body Project (DBP), is an adaptation of the Body Project which is the only eating disorder prevention program to have repeatedly produced effects when evaluated by independent researchers, produced stronger effects than credible alternative interventions, and affected objective outcomes. DBP has been adapted slightly for individuals with T1D who are at ultra-high risk for eating disorders. The study aims to test the effectiveness of the DBP of reducing body image concerns and reducing eating pathology and improving glycemic control.

Screening and Monitoring of Mental Health in Educational Settings: Programme for Detection, Psychoeducation and Self-help

Adolescence is a critical developmental stage during which many mental health problems first emerge. However, a large proportion of these issues go undetected and untreated. Globally, approximately one in seven adolescents experiences mental health difficulties, with increasing trends observed in recent years. Schools offer an important setting for early detection and intervention, yet existing programmes often lack structure or scalability. The MENTOR programme (MENtal Health Tracking, Outreach and Referral) was designed to identify adolescents under psychological distress in educational settings and offer tiered support including psychoeducation, self-help tools, and referral to mental health services when needed. This is a prospective, longitudinal, multicentre study that will be implemented in eight educational centres in Spain, including secondary schools, sixth-form colleges, and vocational training centres. Adolescents and young adults will be invited to participate voluntarily. At baseline and at each trimester, participants will complete validated mental health screening tools assessing common conditions such as anxiety, depression, and emotional dysregulation. Based on results, participants will be assigned to one of several support pathways: access to digital self-help materials, small-group interventions, or referral to school-based or external mental health professionals. Follow-up assessments will measure changes in symptomatology, engagement with self-care tools, and help-seeking behaviour. Quantitative data will be analysed to assess feasibility, adherence, and effectiveness of the intervention over time, and conduct a cost-effectiveness analysis This protocol aims to improve adolescent mental health through a school-based, digitally delivered screening and intervention programme. By evaluating feasibility and acceptance across eight educational centres, the study seeks to generate real-time data on prevalent mental health issues, promote awareness and self-care, and facilitate early professional intervention. If effective, the programme could support scalable, tiered prevention strategies in educational settings, contributing to reduced rates of anxiety, depression, suicidal ideation, eating disorders, and addictions. Its implementation may also improve resource allocation, reduce wait times, and inform future health policies for longitudinal mental health monitoring from childhood. Findings will contribute to the development of accessible, evidence-based models for adolescent mental health promotion and early intervention.

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.

FlexED: Full Threshold ED Substudy

The purpose of this study is to test whether a new digital intervention decreases eating disorder symptoms in young women with eating disorders by changing how they experience thoughts and feelings about their body. The digital intervention is based on Acceptance and Commitment Therapy (ACT). Participants complete up to 7 digital intervention sessions using their mobile phone that include a character, story line and interactive exercises, games and digital rewards. Researchers will examine the impact of the intervention on participants' ability to respond flexibly to body-image distress or triggers, measuring things like heart rate, eye movements, and reaction time to body-image related words and images, and examine changes in eating disorder symptoms before and after intervention.

Pilot Trial of the Body Image Program to Prevent Eating Disorders in Female University Students in Mexico

The goal of this clinical trial is to examine whether the Body Image Program (BIP), a group workshop, is feasible and acceptable to deliver to young women in Mexico. The program is designed to help participants critically evaluate social pressures to be thin and to support healthier body attitudes. The main questions are: * Can the investigators successfully recruit, retain, and engage university students in the program? * Do participants find the program useful and clear? * Does the program show early indications of lowering body dissatisfaction and unhealthy eating attitudes? Participants will: * Attend 2 group sessions, one per week, each lasting approximately 2 hours (120 minutes). * Complete short activities and homework exercises between sessions, such as reflective writing or self-affirmation tasks. * Complete questionnaires at baseline (T1), 2 weeks (T2), and 6 weeks (T3).

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).