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i-BEAT: Binge-Eating Adolescent And Young Adults Treatment – a training program for youth and young adults with binge-eating

i-BEAT: Binge-Eating Adolescent And Young Adults Treatment – a training program for youth and young adults with binge-eating - i-BEAT

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
DRKS
Registry ID
DRKS00023706
Enrollment
700
Registered
2020-11-27
Start date
2021-04-19
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge Eating Disorder Loss of Control Eating Binge Eating Episodes F50.8

Interventions

Group 1: 20-week therapy program for the treatment of adolescents and young adults with Binge Eating and/or Loss of Control Eating (LOC). The program includes treatment according to the current treatm
conducted during study 2), a healthy control group is included. The number of participants for App-based daily life study 1 and study 2 is n=30 BES/LOS and n=30 healthy control group. Thus, a total of

Sponsors

Universität Fribourg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 24 Years

Inclusion criteria

Inclusion criteria: Youth suffering from LOC: Participants fulfilling inclusion criteria are eligible for the study: - Willingness and self-reported motivation to participate - Gender: males, females and others - Age: 14-24 years (according to the term youth defined e.g. by the UN) - Full diagnosis of BED according to DSM-5 - Subclinical BED or LOC (loss of control eating over a subjective amount of food, which does not fulfil the criteria of an objective large amount of food of a fully developed BED (subjective binges): 3 episodes of objective binge episodes or LOC during the last 3 months accompanied by at least 3 out of 5 behavioural indicators (according to DSM-5) and/ or some degree of distress. - Informed Consent as documented by signature: Patients need to give informed consent about the procedure (study 1: questionnaire-base and/or App-based study, and/or study 2: VR Cyberball game and/or epigenetics, and/ or study 3: i-BEAT trial) and confirm their willingness to participate in the full research program (study 1 – 3) or single studies (questionnaire based and/or App-based study 1, study 2 (Cyberball and/or epigenetics) and/or treatment study 3 or combinations of studies. Youth participating in the HCG: Participants fulfilling all of the following inclusion criteria are eligible for the study: - Willingness and self-reported motivation to participate - Gender: males, females and others - Age: 14-24 years (according to the term youth defined e.g. by the UN) - Healthy body weight (BMI 18.5-24.9) - No past or present eating disorder and absence of any present mental disorder - Informed Consent as documented by signature: Patients need to give informed consent about the procedure (study 1: questionnaire-base and App-based study, and/or study 2: Cyberball and epigenetics) and confirm their willingness to participate in the full research program (questionnaire-based and App-based study 1 and 2 (Cyberball and epigenetics) or only in study 1 (questionnaire-based and/or App-based study 1) or study 2 (Cyberball and/or epigenetics: participants in the HCG will not attend i-BEAT study 3 and therefore study 3 will not be part of the informed consent of the HCG).

Exclusion criteria

Exclusion criteria: The presence of any of the following exclusion criteria will lead to exclusion of the participant: - Language/ skills: Patients will be excluded if they do not have self-reported sufficient German language skills - Current or past mental disorder - Pregnancy (App-based study 1, study 2 and 3) - Previous enrolment in the study Additional in- and exclusion criteria apply for study 2, where youth must have intact or corrected vision capacity and are excluded if they report nausea in VR.

Design outcomes

Primary

MeasureTime frame
Study 1: The overall goal of study 1 is to examine cross-sectional and longitudinal associations between adverse social experiences such as social exclusion, rejection sensitivity, emotion regulation problems, mood, LOC and eating disorder pathology in youth. Study 1 consists of two substudies: a questionnaire-based study and an App-based daily-life study. Primary outcome of the questionnaire-based study: - Association of rejection sensitivity with eating disorder pathology (eat, weight and shape concern, restraint eating, and emotional eating; drive for muscularity and excessive exercising; urge to eat), with the number or severity of weekly LOC episodes and with problems of emotion regulation at baseline. - Association of rejection sensitivity with the number or severity of LOC episodes, with problems of emotion regulation and with eating disorder pathology at year 2 - Influence of increasing rejection sensitivity values on primary outcome effects - To examine these associations, we will assess questionnaire-based data of LOC, eating disorder pathology and rejection sensitivity at baseline and one year later. Primary outcome of the App-based daily-life study 1: - Association of self-reported rejection experiences in daily life with negative affect, emotional eating and LOC episodes and dysfunctional emotion regulation across both groups LOC and the HCG - Influence of increasing rejection sensitivity values on primary outcome effects Study 2: The overall goal of study 2 is to examine psychological, physiological and epigenetic correlates of rejection sensitivity and effects of social exclusion in youth with LOC and healthy controls. The experimental induction of social exclusion and rejection sensitivity relies on the Cyberball paradigm (Hartgerink et al., 2015; Rosenbach & Renneberg, 2011; Williams & Jarvis, 2006), where the participant is excluded from a computerized ball-toss game by two avatars (Hartgerink et al., 2015). Primary outcome of study 2 (VR

Secondary

MeasureTime frame
Study 1: Secondary outcome of the questionnaire-based study: - Association of rejection experiences and determinants of rejection sensitivity (past and current); emotion regulation difficulties, negative mood, Body Mass Index (BMI), Thought Shape Fusion, urge to eat and perceived beauty ideal at baseline. Secondary outcome of the App-based daily-life study: - Short-term reduction of negative affect due to emotional eating, the use of dysfunctional emotion regulation strategies and/or LOC episodes - Contribution of emotional eating and/or LOC episodes to increased body dissatisfaction - Influence of increasing rejection sensitivity values on the secondary outcome effects Exploratory aims, epigenetic factors: - percentage of DNA methylation of FK506-binding protein 5 (FKBP5), glucocorticoid receptor gene (NR3C1), transmembrane serotonin transporter gene (SLC6A4) and oxytocin receptor gene (OXTR) between youth with LOC eating (prior to treatment) and a HCG Study 2: Secondary outcome of study 2 (VR Cyberball paradigm): - values of body dissatisfaction and of urge to engage in disinhibited eating after the task and during recovery in youth with LOC compared to HCG Correlates of a rejection sensitivity interpretation bias (underestimation of ball tosses while included, misinterpretation as being excluded during inclusion condition; negative evaluation of ambiguous social scenarios; and distress and estimated low probability of being contacted by peer- players of Cyberball task based on own photo) in youth with LOC compared to HCG - Influence of increasing rejection sensitivity values on the secondary outcome effects - Pupillary dilation response during the exclusion condition and hyperscanning (scan path length) during and after the exclusion in youth with LOC compared to the HCG - Hand posture during and after the exclusion in youth with LOC compared to the HCG - Effects of Cyberball ostracism on Igroup Presence Questionnaire, the social presence survey

Countries

Switzerland

Contacts

Public ContactAnna Rauen

Universität Fribourg/Freiburg

anna.rauen@unifr.ch+41 26 300 7632

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 13, 2026