Feasibility and Acceptability of an App-Based Mindfulness Training for Individuals With Anorexia Nervosa and Bulimia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Acceptability dimensions
研究概览
简要总结
We will evaluate the acceptability and feasibility of a 8-week long digital mindfulness-based intervention for anorexia nervosa and bulimia nervosa.
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) brief daily assessments for the first and last weeks of the study (4 times per day); (3) an initial baseline visit; (4) 8-week web-based intervention (3) a post-intervention assessment (8-weeks after baseline); and (4) a brief 8-week follow-up assessment.
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
- •18 years of age or older
- •Can read and write in English
- •Meet diagnostic DSM 5 diagnostic criteria for anorexia nervosa, bulimia nervosa, or atypical anorexia nervosa/bulimia nervosa
- •Owns a smartphone
- •Willing and able to participate in an eight-week long research study
- •Have a private quiet space at home or headphones to complete modules
- •Completed one month or more of eating disorder treatment
- •Currently enrolled in eating disorder treatment
排除标准
- •Fail to meet above-listed inclusion criteria
- •Current alcohol or drug dependence
- •Current untreated psychotic or bipolar disorder
- •Current suicidal intent
- •Significant cognitive impairment that would impair the ability to use Mindful Courage effectively
- •BMI <15 or medically unstable
- •Currently receiving residential/inpatient treatment
研究组 & 干预措施
Mindful Courage
Mindful Courage is a digital intervention including mindfulness and cognitive behavioral elements for individuals with anorexia nervosa or bulimia nervosa. Mindful Courage will consist of 8-weeks of self-guided modules which will be completed over the course of 8 weeks. Elements included in the intervention include psychoeducation, self-monitoring, regular eating, body image, values clarification, and mindful awareness and acceptance. Participants learn a range mindfulness skills and practice a range of mindfulness meditations. Participants will also receive phone coaching. Homework consists of meditation practices.
干预措施: Mindful Courage (Behavioral)
结局指标
主要结局
Acceptability dimensions
时间窗: 8-week treatment period
Single-items measuring ratings of acceptability dimensions, including usability, understandability, engage-ability, visual appeal, helpfulness, skill acquisition, and confidence implementing skills ratings. Scores for each item range from 1 to 5, , with higher scores indicating better acceptability.
Feasibility
时间窗: 8-week treatment period
Module completion, ranging from 0 to 100%
Feasibility of Module Completion
时间窗: 8-week treatment period
Module completion, ranging from 0 to 100%
Acceptability Dimensions
时间窗: 8-week treatment period
Single-items measuring ratings of acceptability dimensions, including usability, understandability, engage-ability, visual appeal, helpfulness, skill acquisition, and confidence implementing skills ratings. Scores for each item range from 1 to 5 and are averaged, with higher scores indicating better acceptability.
次要结局
- Savoring Beliefs(Baseline to post-treatment(8-weeks) and through 2-month follow-up)
- Change in Mindfulness(Baseline to post-treatment (8-weeks) and through 2-month follow-up)
- Change in Eating Disorder Symptoms(Baseline to post-treatment (8-weeks) and through 2-month follow-up)
- Psychosocial Impairment(Baseline to post-treatment (8-weeks) and through 2-month follow-up)
- Change in Emotion Dysregulation(Baseline to post-treatment (8-weeks) and through 2-month follow-up)
- Change in Body Dissatisfaction(Baseline to post-treatment (8-weeks) and through 2-month follow-up)
- Change in Eating Disorder Symptoms(Baseline through 2-month follow-up)
- Change in Emotion Dysregulation(Baseline through 2-month follow-up)
- Change in Body Dissatisfaction(Baseline through 2-month follow-up)
- Savoring Beliefs(Baseline through 2-month follow-up)
- Psychosocial Impairment(Baseline through 2-month follow-up)
- Change in Mindfulness(Baseline through 2-month follow-up)
研究者
Margaret Sala
Assistant Professor
Yeshiva University