DRKS00023706招募中3 期
i-BEAT: Binge-Eating Adolescent And Young Adults Treatment – a training program for youth and young adults with binge-eating - i-BEAT
niversität Fribourg0 个研究点目标入组 700 人开始时间: 2020年11月27日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 14 Years 至 24 Years（—）
- 性别
- All
入选标准
- •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).
排除标准
- •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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