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Optimizing Mindfulness and Acceptance Based Behavioral Treatment for Bulimia Nervosa and Binge Eating Disorder

Primary Purpose

Bulimia Nervosa, Bulimia; Atypical, Binge-Eating Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Therapy for Eating Disorders
MABT: Mindful Awareness
MABT: Values
MABT: Emotion Modulation
MABT: Distress Tolerance
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bulimia Nervosa focused on measuring Mindfulness and Acceptance Based Behavioral Treatments, Eating Disorders, Bulimia Nervosa, Binge Eating Disorder, Anorexia Nervosa Binge/Purge Type, Binge Eating

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Drexel University, Stratton Hall

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Base BT

Base BT + Distress Tolerance

Base BT + Emotion Regulation

Base BT + Mindful Awareness

Base BT + Values

Base BT + Distress Tolerance and Emotion Modulation

Base BT + Distress Tolerance and Mindful Awareness

Base BT + Distress Tolerance and Values

Base BT + Emotion Modulation and Mindful Awareness

Base BT + Mindful Awareness and Values

Base BT + Emotion Modulation and Values

Base BT + EM, DT, MA

Base BT + DT, ER, and V

Base BT + DT, MA, and V

Base BT + ER, MA, and V

Base BT + ER, MA, V, DT

Arm Description

16 weekly sessions of behavioral therapy.

16 weekly sessions of behavioral therapy with distress tolerance components of MABTs.

16 weekly sessions of behavioral therapy with emotion regulation components of MABTs.

16 weekly sessions of behavioral therapy with mindful awareness components of MABTs.

16 weekly sessions of behavioral therapy with values components of MABTs.

16 weekly sessions of behavioral therapy with emotion regulation and distress tolerance components of MABTs.

16 weekly sessions of behavioral therapy with distress tolerance and mindful awareness components of MABTs.

16 weekly sessions of behavioral therapy with distress tolerance and values components of MABTs.

16 weekly sessions of behavioral therapy with emotion regulation and mindful awareness components of MABTs.

16 weekly sessions of behavioral therapy with values and mindful awareness components of MABTs.

16 weekly sessions of behavioral therapy with emotion regulation and values components of MABTs.

16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and distress tolerance components of MABTs.

16 weekly sessions of behavioral therapy with emotion regulation, distress tolerance, and values components of MABTs.

16 weekly sessions of behavioral therapy with distress tolerance, mindful awareness, and values components of MABTs.

16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and values components of MABTs.

16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, distress tolerance, and values components of MABTs.

Outcomes

Primary Outcome Measures

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
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.
Remission Status
Presence or absence of eating disorder diagnosis. Not in remission; in partial remission; or in full remission.

Secondary Outcome Measures

Compensatory behavior frequency assessed by the Eating Disorder Examination (EDE)
Frequency (number of days and number of instances) of compensatory behaviors assessed by the Eating Disorder Examination
BMI
kilogram/(meters^2), this is an outcome measure for participants with anorexia nervosa, binge/purge type

Full Information

First Posted
September 16, 2020
Last Updated
September 21, 2023
Sponsor
Drexel University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04625959
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 5, 2020 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
MOST: multiphase optimization strategy
Masking
Participant
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Base BT
Arm Type
Active Comparator
Arm Description
16 weekly sessions of behavioral therapy.
Arm Title
Base BT + Distress Tolerance
Arm Type
Experimental
Arm Description
16 weekly sessions of behavioral therapy with distress tolerance components of MABTs.
Arm Title
Base BT + Emotion Regulation
Arm Type
Experimental
Arm Description
16 weekly sessions of behavioral therapy with emotion regulation components of MABTs.
Arm Title
Base BT + Mindful Awareness
Arm Type
Experimental
Arm Description
16 weekly sessions of behavioral therapy with mindful awareness components of MABTs.
Arm Title
Base BT + Values
Arm Type
Experimental
Arm Description
16 weekly sessions of behavioral therapy with values components of MABTs.
Arm Title
Base BT + Distress Tolerance and Emotion Modulation
Arm Type
Experimental
Arm Description
16 weekly sessions of behavioral therapy with emotion regulation and distress tolerance components of MABTs.
Arm Title
Base BT + Distress Tolerance and Mindful Awareness
Arm Type
Experimental
Arm Description
16 weekly sessions of behavioral therapy with distress tolerance and mindful awareness components of MABTs.
Arm Title
Base BT + Distress Tolerance and Values
Arm Type
Experimental
Arm Description
16 weekly sessions of behavioral therapy with distress tolerance and values components of MABTs.
Arm Title
Base BT + Emotion Modulation and Mindful Awareness
Arm Type
Experimental
Arm Description
16 weekly sessions of behavioral therapy with emotion regulation and mindful awareness components of MABTs.
Arm Title
Base BT + Mindful Awareness and Values
Arm Type
Experimental
Arm Description
16 weekly sessions of behavioral therapy with values and mindful awareness components of MABTs.
Arm Title
Base BT + Emotion Modulation and Values
Arm Type
Experimental
Arm Description
16 weekly sessions of behavioral therapy with emotion regulation and values components of MABTs.
Arm Title
Base BT + EM, DT, MA
Arm Type
Experimental
Arm Description
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and distress tolerance components of MABTs.
Arm Title
Base BT + DT, ER, and V
Arm Type
Experimental
Arm Description
16 weekly sessions of behavioral therapy with emotion regulation, distress tolerance, and values components of MABTs.
Arm Title
Base BT + DT, MA, and V
Arm Type
Experimental
Arm Description
16 weekly sessions of behavioral therapy with distress tolerance, mindful awareness, and values components of MABTs.
Arm Title
Base BT + ER, MA, and V
Arm Type
Experimental
Arm Description
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and values components of MABTs.
Arm Title
Base BT + ER, MA, V, DT
Arm Type
Experimental
Arm Description
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, distress tolerance, and values components of MABTs.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Therapy for Eating Disorders
Intervention Description
Change behaviors that maintain binge eating (e.g. rigid dietary restriction outside of binge episodes, irregular or chaotic eating patterns).
Intervention Type
Behavioral
Intervention Name(s)
MABT: Mindful Awareness
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MABT: Values
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MABT: Emotion Modulation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MABT: Distress Tolerance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Binge eating frequency assessed by the Eating Disorder Examination
Description
Frequency (number of days and number of instances) of binge eating over the past 28 days assessed by the Eating Disorder Examination
Time Frame
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6-month and 1 year post-treatment follow-up assessment
Title
Eating Disorder Examination
Description
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.
Time Frame
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment
Title
Remission Status
Description
Presence or absence of eating disorder diagnosis. Not in remission; in partial remission; or in full remission.
Time Frame
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 Outcome Measure Information:
Title
Compensatory behavior frequency assessed by the Eating Disorder Examination (EDE)
Description
Frequency (number of days and number of instances) of compensatory behaviors assessed by the Eating Disorder Examination
Time Frame
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment
Title
BMI
Description
kilogram/(meters^2), this is an outcome measure for participants with anorexia nervosa, binge/purge type
Time Frame
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Facility Information:
Facility Name
Drexel University, Stratton Hall
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Links:
URL
http://drexel.edu/coas/academics/departments-centers/well-center/research/current-research-projects/
Description
For more information, send an email to EDresearch@drexel.edu or call (215) 553-7130

Learn more about this trial

Optimizing Mindfulness and Acceptance Based Behavioral Treatment for Bulimia Nervosa and Binge Eating Disorder

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