Clinical trial NCT04625959: Optimizing Mindfulness and Acceptance Based Behavioral Treatment for Bulimia Nervosa and Binge Eating Disorder
Official title: Optimizing Mindfulness and Acceptance Based Behavioral Treatment for Bulimia Nervosa and Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bulimia Nervosa
Bulimia; Atypical
Binge-Eating Disorder
Binge-Eating and Purging Type Anorexia Nervosa
Binge Eating
Keywords: Mindfulness and Acceptance Based Behavioral Treatments
Eating Disorders
Bulimia Nervosa
Binge Eating Disorder
Anorexia Nervosa Binge/Purge Type
Binge Eating
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-11-12
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: MOST: multiphase optimization strategy
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

1. Have experienced 12 or more loss of control episodes within the previous 3 months
2. Have a BMI above 16
3. Are located in the US and wiling/able to participate in remote treatment and assessments
4. Are able to give consent

Exclusion Criteria:

1. Are unable to fluently speak, write and read English
2. Have a BMI below 16
3. Are receiving treatment for an eating disorder
4. Require immediate treatment for medical complications as a result of eating disorder symptoms
5. 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)

Primary outcomes:
measure: Binge eating frequency assessed by the Eating Disorder Examination
timeFrame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6-month and 1 year post-treatment follow-up assessment
measure: Eating Disorder Examination
timeFrame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment
measure: Remission Status
timeFrame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment
Secondary outcomes:
measure: Compensatory behavior frequency assessed by the Eating Disorder Examination (EDE)
timeFrame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment
measure: BMI
timeFrame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University, Stratton Hall
state: Pennsylvania
Study officials:
References: