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临床试验/NCT06107387
NCT06107387已完成不适用

Binge Eating Self-help for Teens (BEST): A Pilot and Feasibility Test of an Online Behavioral Intervention for Adolescents With Binge Eating and Elevated Weight

Yale University2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2024年2月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Attendance

研究概览

简要总结

This study is a pilot clinical trial of a new guided self-help CBT for binge eating. Participants will complete an intake assessment; following determination of eligibility, participants will then complete four months of treatment (weekly guided self-help sessions). At the end of treatment, participants will complete an interview with a research clinician to assess outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • To be included, adolescents must:
  • Be in the age range ≥12 years old and ≤17 years old;
  • Have a BMI that places them above the 85th percentile based on their age and sex;
  • Report 2 episodes of binge/LOC eating (feeling a loss of control while eating) per month for the past 3 months;
  • Be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions);
  • Read, comprehend, and write English at a sufficient level to complete study-related materials;
  • Provide a signed and dated written assent prior to study participation;
  • Provide a signed and dated written consent from one parent prior to study participant; and
  • Be available for participation in the study for 4 months.

排除标准

  • Prospective participants will be excluded if the adolescent:
  • Has a medical or psychiatric condition that would require hospitalization or intensive care (e.g., neurological disorder, psychotic disorders, suicidality);
  • Has a medical or psychiatric condition that would prohibit them from engaging in behavioral treatment or moderate physical activity (e.g., cardiovascular problems);
  • Has uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension);
  • Is pregnant or breastfeeding;
  • Is taking medication(s) or participating in treatment(s) that could influence weight or appetite;
  • Began taking hormonal contraceptives less than 3 months prior;
  • Has a developmental or cognitive disorder (e.g., autism spectrum disorder);
  • Has a concurrent feeding/eating disorder (e.g., bulimia nervosa); or
  • Is participating in another clinical research study.

研究组 & 干预措施

Binge Eating Self-help for Teens

Experimental

Participants will have 16 guided self-help sessions (4 months; weekly sessions for adolescents with parents joining monthly). Participants will complete daily self-monitoring of eating behaviors (timing of meals and snacks; whether or not a binge occurred) throughout treatment. Treatment sessions involve a self-help component, which includes brief videos that participants watch at home. Treatment sessions also involve a guidance component (brief consultation), which is 15-30 minutes on a secure videoconferencing platform (e.g., Zoom) between the therapist and the participant. These sessions focus on clarifying material, reviewing self-monitoring and looking for patterns, and problem-solving maladaptive thinking patterns and binge behaviors.

干预措施: Binge Eating Self-help for Teens (Behavioral)

结局指标

主要结局

Attendance

时间窗: 4 months

Number of participants attending \>75% of sessions

Retention

时间窗: 4 months

Number of participants who attend through the end of treatment

次要结局

  • Treatment Credibility(1 week)
  • Treatment Satisfaction(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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