Digital Mindfulness Meditation-enhanced Cognitive Behavioral Therapy (CBT-MM) for Binge Eating Disorder User-Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
The investigators will evaluate the acceptability and feasibility of a 18-week long digital mindfulness-based and cognitive behavioral therapy intervention for binge eating disorder.
This study is a prospective single-arm trial during the intervention development phase. Following this phase, after the intervention has been further developed, a subsequent study (with a different clinicaltrials.gov identification #) will utilize a randomized control trial design.
详细描述
Procedures include completing: (1) pre-intervention screening assessment; (2) an initial baseline visit; (3) 18-week web-based intervention; and (4) a post-intervention assessment (18-weeks after baseline).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Meeting DSM-5 criteria for Binge Eating Disorder (BED)
- •English-speaking
排除标准
- •BMI < 18.5
- •Requiring immediate treatment for medical complications
- •Current anorexia or bulimia nervosa or purging behaviors within the past year
- •Already receiving treatment for an ED or participating in a weight loss program or psychotherapy focused on weight (psychotherapy for other conditions was allowed)
- •Currently pregnant or breast-feeding
- •Experiencing other severe psychopathology or medical illness that would limit the participants' ability to comply with the demands of the current study (e.g. active psychotic disorder, cancer)
研究组 & 干预措施
Digital CBT-MM
Digital CBT-MM is a digital intervention including mindfulness and cognitive behavioral elements for individuals with binge eating disorder. Mindful Courage will consist of 18-weeks of self-guided modules. Elements included in the intervention include psychoeducation, self-monitoring, regular eating, goal-setting, weekly weighing, eating a sufficient amount of food at each meal, eating a range of foods (including foods that patients may fear), reduction of overvaluation of weight and shape, addressing shape/body checking or avoidance, behavior chain analysis, problem solving, awareness and acceptance of binge eating urges, thoughts and emotions, values awareness, values clarification, values-based decision making, self-compassion, exploring needs underlying binge eating urges, mindful eating, hunger and fullness awareness, self-compassion, and self-care. Weekly mindfulness practice (at least 3x per week) is heavily emphasized.
干预措施: Meditation-enhanced Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Acceptability
时间窗: 18-week treatment period
Single-items measuring dimensions of acceptability, including overall satisfaction, engagement, visual appeal of content, understandability of program material, desire to continue the program, and overall helpfulness. Scores for each item range from 1 to 5, , with higher scores indicating better acceptability.
Feasibility/Completion
时间窗: 18-week treatment period
Module completion, ranging from 0 to 100%
次要结局
- Changes in Emotion Dysregulation(Baseline to post-treatment (18-weeks))
- Changes in Mindfulness(Baseline to post-treatment (18-weeks))
- Changes in Objective Binge Eating Episodes(Baseline to post-treatment (18-weeks))
- Change in Body Mass Index (BMI)(Baseline to post-treatment (18-weeks))
- Changes in Dietary Restraint(Baseline to post-treatment (18-weeks))
- Changes in Quality of Life(Baseline to post-treatment (18-weeks))
- Changes in Depression Symptoms(Baseline to post-treatment (18-weeks))