Optimizing Mindfulness and Acceptance Based Behavioral Treatment for Bulimia Nervosa and Binge Eating Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Binge eating frequency assessed by the Eating Disorder Examination
研究概览
简要总结
The current study will use a full factorial design to identify the independent and combined effects of four core MABT components when combined with standard behavioral treatment for BN and BED. The primary aim of the study will be to evaluate the independent efficacy of Mindful Awareness, Distress Tolerance, Emotion Modulation, and Values-Based Decision Making on eating pathology (at posttreatment and at 6 and 12-month follow-ups). Secondary aims will be (1) to test target engagement of each MABT component, i.e., to confirm that each treatment component impacts both the variable which it targets and self-regulation and that improvements in these are associated with improvements in outcomes and (2) to test the hypotheses that the efficacy of each component is moderated by related baseline deficits in self-regulation (e.g. individuals with worse distress tolerance at baseline are most likely to benefit from conditions that include the Distress Tolerance component). A final exploratory aim will be to quantify the component interaction effects, which may be partially additive (because components overlap and/or there is diminishing return), fully additive, or synergistic (in that components may partially depend on each other).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have experienced 12 or more loss of control episodes within the previous 3 months
- •Have a BMI above 16
- •Are located in the US and wiling/able to participate in remote treatment and assessments
- •Are able to give consent
排除标准
- •Are unable to fluently speak, write and read English
- •Have a BMI below 16
- •Are receiving treatment for an eating disorder
- •Require immediate treatment for medical complications as a result of eating disorder symptoms
- •Have a mental handicap, or are experiencing other severe psychopathology that would limit the participants' ability to comply with the demands of the current study (e.g. severe depression with suicidal intent, active psychotic disorder)
研究组 & 干预措施
Base BT
16 weekly sessions of behavioral therapy.
干预措施: Behavioral Therapy for Eating Disorders (Behavioral)
Base BT + Distress Tolerance
16 weekly sessions of behavioral therapy with distress tolerance components of MABTs.
干预措施: MABT: Distress Tolerance (Behavioral)
Base BT + Emotion Regulation
16 weekly sessions of behavioral therapy with emotion regulation components of MABTs.
干预措施: MABT: Emotion Modulation (Behavioral)
Base BT + Mindful Awareness
16 weekly sessions of behavioral therapy with mindful awareness components of MABTs.
干预措施: MABT: Mindful Awareness (Behavioral)
Base BT + Values
16 weekly sessions of behavioral therapy with values components of MABTs.
干预措施: MABT: Values (Behavioral)
Base BT + Distress Tolerance and Emotion Modulation
16 weekly sessions of behavioral therapy with emotion regulation and distress tolerance components of MABTs.
干预措施: MABT: Emotion Modulation (Behavioral)
Base BT + Distress Tolerance and Emotion Modulation
16 weekly sessions of behavioral therapy with emotion regulation and distress tolerance components of MABTs.
干预措施: MABT: Distress Tolerance (Behavioral)
Base BT + Distress Tolerance and Mindful Awareness
16 weekly sessions of behavioral therapy with distress tolerance and mindful awareness components of MABTs.
干预措施: MABT: Mindful Awareness (Behavioral)
Base BT + Distress Tolerance and Mindful Awareness
16 weekly sessions of behavioral therapy with distress tolerance and mindful awareness components of MABTs.
干预措施: MABT: Distress Tolerance (Behavioral)
Base BT + Distress Tolerance and Values
16 weekly sessions of behavioral therapy with distress tolerance and values components of MABTs.
干预措施: MABT: Values (Behavioral)
Base BT + Distress Tolerance and Values
16 weekly sessions of behavioral therapy with distress tolerance and values components of MABTs.
干预措施: MABT: Distress Tolerance (Behavioral)
Base BT + Emotion Modulation and Mindful Awareness
16 weekly sessions of behavioral therapy with emotion regulation and mindful awareness components of MABTs.
干预措施: MABT: Mindful Awareness (Behavioral)
Base BT + Emotion Modulation and Mindful Awareness
16 weekly sessions of behavioral therapy with emotion regulation and mindful awareness components of MABTs.
干预措施: MABT: Emotion Modulation (Behavioral)
Base BT + Mindful Awareness and Values
16 weekly sessions of behavioral therapy with values and mindful awareness components of MABTs.
干预措施: MABT: Mindful Awareness (Behavioral)
Base BT + Mindful Awareness and Values
16 weekly sessions of behavioral therapy with values and mindful awareness components of MABTs.
干预措施: MABT: Values (Behavioral)
Base BT + Emotion Modulation and Values
16 weekly sessions of behavioral therapy with emotion regulation and values components of MABTs.
干预措施: MABT: Values (Behavioral)
Base BT + Emotion Modulation and Values
16 weekly sessions of behavioral therapy with emotion regulation and values components of MABTs.
干预措施: MABT: Emotion Modulation (Behavioral)
Base BT + EM, DT, MA
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and distress tolerance components of MABTs.
干预措施: MABT: Mindful Awareness (Behavioral)
Base BT + EM, DT, MA
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and distress tolerance components of MABTs.
干预措施: MABT: Emotion Modulation (Behavioral)
Base BT + EM, DT, MA
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and distress tolerance components of MABTs.
干预措施: MABT: Distress Tolerance (Behavioral)
Base BT + DT, ER, and V
16 weekly sessions of behavioral therapy with emotion regulation, distress tolerance, and values components of MABTs.
干预措施: MABT: Values (Behavioral)
Base BT + DT, ER, and V
16 weekly sessions of behavioral therapy with emotion regulation, distress tolerance, and values components of MABTs.
干预措施: MABT: Emotion Modulation (Behavioral)
Base BT + DT, ER, and V
16 weekly sessions of behavioral therapy with emotion regulation, distress tolerance, and values components of MABTs.
干预措施: MABT: Distress Tolerance (Behavioral)
Base BT + DT, MA, and V
16 weekly sessions of behavioral therapy with distress tolerance, mindful awareness, and values components of MABTs.
干预措施: MABT: Mindful Awareness (Behavioral)
Base BT + DT, MA, and V
16 weekly sessions of behavioral therapy with distress tolerance, mindful awareness, and values components of MABTs.
干预措施: MABT: Values (Behavioral)
Base BT + DT, MA, and V
16 weekly sessions of behavioral therapy with distress tolerance, mindful awareness, and values components of MABTs.
干预措施: MABT: Distress Tolerance (Behavioral)
Base BT + ER, MA, and V
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and values components of MABTs.
干预措施: MABT: Mindful Awareness (Behavioral)
Base BT + ER, MA, and V
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and values components of MABTs.
干预措施: MABT: Values (Behavioral)
Base BT + ER, MA, and V
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and values components of MABTs.
干预措施: MABT: Emotion Modulation (Behavioral)
Base BT + ER, MA, V, DT
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, distress tolerance, and values components of MABTs.
干预措施: MABT: Mindful Awareness (Behavioral)
Base BT + ER, MA, V, DT
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, distress tolerance, and values components of MABTs.
干预措施: MABT: Values (Behavioral)
Base BT + ER, MA, V, DT
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, distress tolerance, and values components of MABTs.
干预措施: MABT: Emotion Modulation (Behavioral)
Base BT + ER, MA, V, DT
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, distress tolerance, and values components of MABTs.
干预措施: MABT: Distress Tolerance (Behavioral)
结局指标
主要结局
Binge eating frequency assessed by the Eating Disorder Examination
时间窗: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6-month and 1 year post-treatment follow-up assessment
Frequency (number of days and number of instances) of binge eating over the past 28 days assessed by the Eating Disorder Examination
Eating Disorder Examination
时间窗: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment
The Eating Disorder Examination is a semi-structured interview that measures eating pathology. The EDE yields four subscale scores: Restraint, Eating Concern, Shape Concern, and Weight Concern. The possible score range for each subscale is 0 to 6. The total score may also be reported (determined by averaging the subscale scores); the score range for the total score is also 0 to 6. For subscale scores and total score, higher scores indicate more severe pathology. The restraint sub-scale of the EDE will be used to assess utilization of skills related to reducing dietary restraint.
Remission Status
时间窗: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment
Presence or absence of eating disorder diagnosis. Not in remission; in partial remission; or in full remission.
次要结局
- Compensatory behavior frequency assessed by the Eating Disorder Examination (EDE)(Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment)
- BMI(Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment)