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临床试验/NCT03777189
NCT03777189终止不适用

Cognitive-Behavioral and Physical Activity Interventions for Binge Eating and Overweight

Yale University2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2018年12月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
2
主要终点
Binge-eating frequency

研究概览

简要总结

This study aims to perform an open-series pilot trial to examine the efficacy of cognitive-behavioral therapy delivered in a guided self-help format (CBTgsh) with added content related to physical activity (PA), for the treatment of binge-eating disorder (BED), operationalized as BED full diagnostic criteria or BED with the full criteria except for the binge episode size criterion.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 to 65 years old;
  • Meet DSM-5 criteria for BED or BED but without the size criterion (LOC eating);
  • BMI 25-45 kg/m2;
  • Sedentary activity pattern (< 90 mins/week of moderate-to-vigorous intensity recreational physical activity);
  • Available for the duration of the treatment and follow-up (7 months);
  • Read, comprehend, and write English at a sufficient level to complete study-related materials.
  • Exclusion criteria:
  • Co-existing psychiatric condition that requires hospitalization or more intensive treatment (e.g., bipolar mood disorders, psychotic illnesses, severe depression).
  • Reports active suicidal or homicidal ideation.
  • Current anorexia or bulimia nervosa.
  • Contraindications to physical activity.
  • Blood pressure >140 systolic or >90 diastolic.
  • Breast-feeding or pregnant, or planning to become pregnant during the study.
  • History of stroke or myocardial infarction.
  • Current or recent (within 12 months) drug or alcohol dependence
  • Currently receiving effective treatment for eating or weight loss.
  • Currently participating in another clinical study.

排除标准

  • 未提供

研究组 & 干预措施

Cognitive-Behavioral Therapy

Experimental

Cognitive-behavioral therapy will be delivered in line with recommendations (e.g., NICE 2017). Format will be guided self help with added content related to physical activity.

干预措施: Cognitive-Behavioral Therapy (Behavioral)

结局指标

主要结局

Binge-eating frequency

时间窗: Post-treatment (4 months)

Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).

Body mass index

时间窗: Post-treatment (4 months)

BMI is calculated using measured height and weight (e.g., percent loss)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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