Trial document




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  DRKS00023706

Trial Description

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Title

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

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Trial Acronym

i-BEAT

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URL of the Trial

http://unifr.ch/go/i-beat

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Brief Summary in Lay Language

Background and main purpose of the study:
The common theme to all the i-BEAT sub-studies in is that they help is to help us understand how loss of control eating occurs, why the problem is persists and how it can be treated most efficiently.

Procedures and aims of the sub-studies:
- "i-BEAT App": A smartphone app is used to learn more about social exclusion experiences and its effects on mood and eating behaviour in adolescents and young adults with Binge Eating Disorder (BED) and/or loss of control eating.
- "i-BEAT VR": In this laboratory study we aim to investigate the psychological and physiological effects of interpersonal interaction in virtual reality (VR).
- "i-BEAT Online": With this third study we investigate the effectiveness and efficacy of an internet-based treatment program for the therapy of Binge Eating and/or loss of control eating in adolescents and young adults.
- "i-BEAT Epigenetics": By means of saliva samples, it is investigated, how experiences in everyday life can affect the expression of genetic traits.

Participants:
This study is open to all adolescents/young adults between 14 and 24 years suffering from binge-eating disorder, regular binge eating and/or a feelings of loss of control when eating. People without these characteristics can participate as a comparison group. Participants also need a smartphone, an internet access to receive emails and a high level of German language skills to be able to participate in one of the studies. Adolescents/young adults who suffer from another serious mental illness that needs to be treated first or adolescents/young adults who are pregnant cannot participate.

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Brief Summary in Scientific Language

Based on the pilot study BEAT (primary register number: DRKS00014580), this research program will investigate aetiological factors of Loss of Control Eating (LOC) in youth applying a mixed longitudinal and cross-sectional questionnaire survey and experimental study with two waves (T0 + second assessment after one year and an App-based daily life assessment (study 1) as well as a VR study to assess social exclusion and social rejection sensitivity (study 2). VR increases the ecological validity of the assessment of social rejection sensitivity (increases feeling of reality and to be part of the Cyberball paradigm). VR furthermore allows assessing self-reported feelings immediately during the task as well as the assessment of eye-gaze, posture and physiological correlates (heart rate variability, HRV) in male and female youth with LOC. A gamified stop signal task (SST) procedure allows an engaging and objective approach to inhibition and thus impulsivity measures in the context of binge eating BE and LOC eating in youth. In addition, based on our experiences during the treatment pilot study including three age-adapted face-to-face group-workshops and 6 standardized email-guided self-help sessions (DRKS00014580), we improved treatment content by delivering treatment with 6 state of the art CBT-E treatement sessions for Binge Eating Disorder and LOC and 6 Interpersonal emotion regulation sessions. Accessibility of the treatment content which was previously delivered during the workshops is further improved by using a modified and streamlined version of our online-treatment platform (Munsch et al., 2019a) (i-BEAT, study 3). Morever, we reacted to our experience during the pilot trial BEAT by providing two optional treatment session in individual cases, where subclinical compensatory behaviours are present in youth with LOC eating or binge eating.

Sources: Munsch, S., Wyssen, A., Vanhulst, P., Lalanne, D., Steinemann, S., & Tuch, A. (2019a). Binge- Eating Disorder Treatment Goes Online - A Randomized Controlled Trial with a waitlist and a Placebo Control Group to Evaluate Feasibility, Usability and Treatment Outcome of an Internet-Based Treatment for Binge-Eating Disorder. Trials.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

Youths acceptance of the open data access will be evaluated in in study 1. As an exception, the SNSF accepts to allow youth in our study to decide whether or not they are willing to deposit their coded and anonymized data for other researchers on one of the suggested data repositories of the SNSF (http://www.snf/SiteCollectionDocuments/FAIR data repositories examples.pdf). We decided to use ZENODO (https://zenodo.org) as the public data repository for this study. Zenodo is a non-commercial data repository provided by the CERN with server location in Switzerland which ensures data to be treated by Swiss law and thus Swiss data security and privacy standards. Zenodo offers the possibility to make data files publicly available by providing a globally unique and persistent identifier, i.e. a DOI. Furthermore, data accessible by such DOIs is stored for years, which is guaranteed by a long-term preservation plan (https://about.zenodo.org/policies/). The company allows to publish data with different creative commons (CC) licenses and, thus, the data availability can be as open or restricted as we choose. Zenodo is provided and funded by CERN, a trustworthy, Swiss research institution: CERN - European Organization for Nuclear Research att: IT Department, Digital Repositories Section,1211 Genève 23, Switzerland.

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Organizational Data

  •   DRKS00023706
  •   2020/11/27
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  •   yes
  •   Approved
  •   2019-01277, Swissethics: Ethikkommission Bern
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F50.8 -  Other eating disorders
  •   Binge Eating Disorder
  •   Loss of Control Eating
  •   Binge Eating Episodes
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Interventions/Observational Groups

  •   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 treatment of choice for binge eating disorder: Cognitive Behavioural Therapy for Eating Disorders (CBT-E). In addition, all patients receive a therapy module that was developed in our work group: Interpersonal Emotional Regulation Therapy (INTER-E). The program comprises 6 CBT-E sessions and 6 INTER-E sessions. Optionally, patients with subclinical forms of compensatory behaviours similar to Bulimia Nervosa are treated with two respective sessions. Follow-up sessions are conducted 3 and 6 months after end of treatment. All patients participate in the 4-week waiting-control condition, the CBT-E module and the INTER-E module (wait-list-controlled-condition).
  •   Healthy control group: For the cross-sectional study 1 screening (n=600), we conduct a survey in the general population (respecting of course the described inclusion and exclusion criteria). For the investigation of social rejection sensitivity in the experimental study (laboratory based Study 2 comprising the Cyberball paradigm), the App-based daily life study (App-based daily life study 1), the investigation of impulsivity (Stop Signal Task, conducted during study 2) and for the investigation of underlying epigenetic factors (buccal swabs; 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 n = 60 participants take part in app-based daily life study 1 and study 2. Note, the study at hand allows participants to chose their preferred sub-studies. Thus e.g. some of the n = 60 participants in the app-based daily life study 1 do not take part in study 2 and vice versa. In general the healthy control group does not participate in the i-BEAT treatment program. In contrast, study 3 is controlled with a wait-list control condition completed by every patient before the actual treatment.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Other
  •   Treatment
  •   Parallel
  •   III
  •   N/A
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Primary Outcome

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 Cyberball game):
- social threat-related effects during (lower HRV) and after the exclusion (lower HRV; increased negative/reduced positive affect; impairment of basic needs, impaired subjective and objective inhibition) and a delayed recovery in youth with LOC compared to the HCG (lower HRV)
- Influence of increasing rejection sensitivity values on primary outcome effects

Study 3:
The overall goal of the i-BEAT study 3 is to examine the efficacy of a 6-sessions CBT-E and interpersonal emotion regulation (INTER-E) online intervention to treat LOC and interpersonal difficulties (such as rejection sensitivity and effects of social exclusion) in youth aged 14-24 years.

Primary outcomes of the study 3 i-BEAT trial:
- Reduction of the number or the severity of weekly LOC episodes, problems of emotion regulation, the eating disorder pathology and negative mood from pre- to post treatment and in comparison with a 4-weeks’ waiting period.
- Reduction of weekly rejection sensitivity experiences, instances of problematic emotion regulation and negative mood in the INTER-E module in comparison with the CBT-E module.
- Reduction of the number or the severity of weekly LOC episodes (wLOC) and urge to engage in disinhibited eating in comparison with the interpersonal emotion regulation module.
- Further improvement of rejection sensitivity experiences, emotion regulation capacities, number and severity of weekly LOC episodes and urge to engage in disinhibited eating of applying additional CBT-E or INTER-E module and leveling of initial treatment specific effects.

Sources:
Hartgerink, C. H. J., van Beest, I., Wicherts, J. M., & Williams, K. D. (2015). The Ordinal Effects of Ostracism: A Meta-Analysis of 120 Cyberball Studies. Plos One, 10(5). doi:10.1371/journal.pone.0127002
Rosenbach, C., & Renneberg, B. (2011). Rejected, Excluded, Ignored: The Perception of Social Rejection and Mental Disorders - a Review. Verhaltenstherapie, 21(2), 87-98. doi:10.1159/000328839
Williams, K. D., & Jarvis, B. (2006). Cyberball: A program for use in research on interpersonal ostracism and acceptance. Behavior Research Methods, 38(1), 174-180. doi:10.3758/Bf03192765

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Secondary Outcome

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, motion sickness measured by the Simulator Sickness Questionnaire and Virtual Body Ownership Questionnaire

Study 3:
Secondary outcome of the i-BEAT trial:
- Stability of the effects of the initial interpersonal emotion regulation (INTER-E) or the CBT-E module during a 3-weeks pause
- Therapist rating of the change of patient’s condition prior compared to after i-BEAT.

Exploratory aims, epigenetic factors:
- Predictive value and change of DNA methylation of FK506-binding protein 5 (FKBP5), glucocorticoid receptor gene (NR3C1), transmembrane serotonin transporter gene (SLC6A4) and oxytocin receptor gene (OXTR) in youth with LOC eating (prior and after i-BEAT)


Other Outcomes of Interest
Socio-demographic- and health-related behavioral variables, correlates of general psychopathology, thought shape fusion, gender identity, sexual orientation, immigration background, social media use and the beauty ideal will be explored as moderators and mediators of the treatment outcome and compared between youth with LOC and the HCG.
Feasibility (acceptance, suitability and adherence) to the treatment will be assessed weekly with the working alliance inventory and according to the therapists note on the CRF of the corresponding participant.

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2021/04/19
  •   700
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   14   Years
  •   24   Years
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Additional 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).

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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.

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Addresses

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    • Universität Fribourg
    • Ms.  Prof.  Simone  Munsch 
    • Rue P.A. de Faucigny 2
    • CH-1700  Fribourg
    • Switzerland
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    • Universität Fribourg/Freiburg
    • Ms.  Prof.  Simone  Munsch 
    • Rue P.A. de Faucigny 2
    • 1700  Fribourg/Freiburg
    • Switzerland
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    • Universität Fribourg/Freiburg
    • Mr.  M.Sc.  Adrian  Naas 
    • Rue P.A. de Faucigny 2
    • CH-1700  Fribourg
    • Switzerland
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    • Universität Fribourg
    • Ms.  M.Sc.  Verena  Müller 
    • Rue P.A. de Faucigny 2
    • CH-1700  Fribourg
    • Switzerland
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Sources of Monetary or Material Support

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    • Schweizer Nationalfonds (SNF)
    • Wildhainweg 3
    • CH-3001  Bern
    • Switzerland
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    • Universität Fribourg/Freiburg
    • Ms.  Prof.  Simone  Munsch 
    • Rue P.A. de Faucigny 2
    • 1700  Fribourg/Freiburg
    • Switzerland
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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