Optimizing Mindfulness and Acceptance Based Behavioral Treatment for Bulimia Nervosa and Binge Eating Disorder
1 other identifier
interventional
256
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 5, 2020
CompletedFirst Submitted
Initial submission to the registry
September 16, 2020
CompletedFirst Posted
Study publicly available on registry
November 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedSeptember 25, 2023
September 1, 2023
3.8 years
September 16, 2020
September 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Binge eating frequency assessed by the Eating Disorder Examination
Frequency (number of days and number of instances) of binge eating over the past 28 days assessed by the Eating Disorder Examination
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6-month and 1 year post-treatment follow-up assessment
Eating Disorder Examination
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.
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment
Remission Status
Presence or absence of eating disorder diagnosis. Not in remission; in partial remission; or in full remission.
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 (2)
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
Study Arms (16)
Base BT
ACTIVE COMPARATOR16 weekly sessions of behavioral therapy.
Base BT + Distress Tolerance
EXPERIMENTAL16 weekly sessions of behavioral therapy with distress tolerance components of MABTs.
Base BT + Emotion Regulation
EXPERIMENTAL16 weekly sessions of behavioral therapy with emotion regulation components of MABTs.
Base BT + Mindful Awareness
EXPERIMENTAL16 weekly sessions of behavioral therapy with mindful awareness components of MABTs.
Base BT + Values
EXPERIMENTAL16 weekly sessions of behavioral therapy with values components of MABTs.
Base BT + Distress Tolerance and Emotion Modulation
EXPERIMENTAL16 weekly sessions of behavioral therapy with emotion regulation and distress tolerance components of MABTs.
Base BT + Distress Tolerance and Mindful Awareness
EXPERIMENTAL16 weekly sessions of behavioral therapy with distress tolerance and mindful awareness components of MABTs.
Base BT + Distress Tolerance and Values
EXPERIMENTAL16 weekly sessions of behavioral therapy with distress tolerance and values components of MABTs.
Base BT + Emotion Modulation and Mindful Awareness
EXPERIMENTAL16 weekly sessions of behavioral therapy with emotion regulation and mindful awareness components of MABTs.
Base BT + Mindful Awareness and Values
EXPERIMENTAL16 weekly sessions of behavioral therapy with values and mindful awareness components of MABTs.
Base BT + Emotion Modulation and Values
EXPERIMENTAL16 weekly sessions of behavioral therapy with emotion regulation and values components of MABTs.
Base BT + EM, DT, MA
EXPERIMENTAL16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and distress tolerance components of MABTs.
Base BT + DT, ER, and V
EXPERIMENTAL16 weekly sessions of behavioral therapy with emotion regulation, distress tolerance, and values components of MABTs.
Base BT + DT, MA, and V
EXPERIMENTAL16 weekly sessions of behavioral therapy with distress tolerance, mindful awareness, and values components of MABTs.
Base BT + ER, MA, and V
EXPERIMENTAL16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and values components of MABTs.
Base BT + ER, MA, V, DT
EXPERIMENTAL16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, distress tolerance, and values components of MABTs.
Interventions
Change behaviors that maintain binge eating (e.g. rigid dietary restriction outside of binge episodes, irregular or chaotic eating patterns).
Integrates behavioral treatment for eating disorders with a set of psychological strategies, specifically mindful awareness, designed to enhance self-regulation. Mindful awareness strategies include developing inner and outer wisdom, formal meditation, and shifting awareness to the present moment. Mindful awareness skills also include increasing awareness of thoughts, feelings, physical sensations, and hunger and fullness cues.
Integrates behavioral treatment for eating disorders with a set of psychological strategies, specifically values, designed to enhance self-regulation. Values skills include identifying and clarifying values, living a values life, making values-consistent decisions, addressing competing values, values awareness, and using values to address negative moods.
Integrates behavioral treatment for eating disorders with a set of psychological strategies, specifically emotion modulation, designed to enhance self-regulation. Emotion modulation skills include long-term habits for emotion regulation, coping strategies, crisis management, and cognitive reappraisal.
Integrates behavioral treatment for eating disorders with a set of psychological strategies, specifically distress tolerance, designed to enhance self-regulation. Distress tolerance skills include psychological acceptance, uncoupling, willingness, and dealing with dirty distress.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Drexel Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Drexel University, Stratton Hall
Philadelphia, Pennsylvania, 19104, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2020
First Posted
November 12, 2020
Study Start
June 5, 2020
Primary Completion
April 1, 2024
Study Completion
April 1, 2024
Last Updated
September 25, 2023
Record last verified: 2023-09