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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Binge-Eating Disorder; Bulimia Nervosa; Binge Eating; Bulimia; Atypical; Binge-Eating and Purging Type Anorexia Nervosa
• Intervention / Treatment: Behavioral: Behavioral Therapy for Eating Disorders; Behavioral: MABT: Distress Tolerance; Behavioral: MABT: Emotion Modulation; Behavioral: MABT: Mindful Awareness; Behavioral: MABT: Values

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Coordinator; Phone Number: 215-553-7130; Email: EDresearch@drexel.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Drexel University, Stratton Hall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Base BT; 16 weekly sessions of behavioral therapy.	Behavioral: Behavioral Therapy for Eating Disorders; Change behaviors that maintain binge eating (e.g. rigid dietary restriction outside of binge episodes, irregular or chaotic eating patterns).
Experimental: Base BT + Distress Tolerance; 16 weekly sessions of behavioral therapy with distress tolerance components of MABTs.	Behavioral: MABT: Distress Tolerance; 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.
Experimental: Base BT + Emotion Regulation; 16 weekly sessions of behavioral therapy with emotion regulation components of MABTs.	Behavioral: MABT: Emotion Modulation; 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.
Experimental: Base BT + Mindful Awareness; 16 weekly sessions of behavioral therapy with mindful awareness components of MABTs.	Behavioral: MABT: Mindful Awareness; 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.
Experimental: Base BT + Values; 16 weekly sessions of behavioral therapy with values components of MABTs.	Behavioral: MABT: Values; 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.
Experimental: Base BT + Distress Tolerance and Emotion Modulation; 16 weekly sessions of behavioral therapy with emotion regulation and distress tolerance components of MABTs.	Behavioral: MABT: Distress Tolerance; 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.; Behavioral: MABT: Emotion Modulation; 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.
Experimental: Base BT + Distress Tolerance and Mindful Awareness; 16 weekly sessions of behavioral therapy with distress tolerance and mindful awareness components of MABTs.	Behavioral: MABT: Distress Tolerance; 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.; Behavioral: MABT: Mindful Awareness; 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.
Experimental: Base BT + Distress Tolerance and Values; 16 weekly sessions of behavioral therapy with distress tolerance and values components of MABTs.	Behavioral: MABT: Distress Tolerance; 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.; Behavioral: MABT: Values; 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.
Experimental: Base BT + Emotion Modulation and Mindful Awareness; 16 weekly sessions of behavioral therapy with emotion regulation and mindful awareness components of MABTs.	Behavioral: MABT: Emotion Modulation; 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.; Behavioral: MABT: Mindful Awareness; 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.
Experimental: Base BT + Mindful Awareness and Values; 16 weekly sessions of behavioral therapy with values and mindful awareness components of MABTs.	Behavioral: MABT: Mindful Awareness; 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.; Behavioral: MABT: Values; 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.
Experimental: Base BT + Emotion Modulation and Values; 16 weekly sessions of behavioral therapy with emotion regulation and values components of MABTs.	Behavioral: MABT: Emotion Modulation; 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.; Behavioral: MABT: Values; 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.
Experimental: Base BT + EM, DT, MA; 16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and distress tolerance components of MABTs.	Behavioral: MABT: Distress Tolerance; 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.; Behavioral: MABT: Emotion Modulation; 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.; Behavioral: MABT: Mindful Awareness; 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.
Experimental: Base BT + DT, ER, and V; 16 weekly sessions of behavioral therapy with emotion regulation, distress tolerance, and values components of MABTs.	Behavioral: MABT: Distress Tolerance; 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.; Behavioral: MABT: Emotion Modulation; 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.; Behavioral: MABT: Values; 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.
Experimental: Base BT + DT, MA, and V; 16 weekly sessions of behavioral therapy with distress tolerance, mindful awareness, and values components of MABTs.	Behavioral: MABT: Distress Tolerance; 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.; Behavioral: MABT: Mindful Awareness; 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.; Behavioral: MABT: Values; 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.
Experimental: Base BT + ER, MA, and V; 16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and values components of MABTs.	Behavioral: MABT: Emotion Modulation; 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.; Behavioral: MABT: Mindful Awareness; 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.; Behavioral: MABT: Values; 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.
Experimental: Base BT + ER, MA, V, DT; 16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, distress tolerance, and values components of MABTs.	Behavioral: MABT: Distress Tolerance; 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.; Behavioral: MABT: Emotion Modulation; 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.; Behavioral: MABT: Mindful Awareness; 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.; Behavioral: MABT: Values; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	kilogram/(meters^2), this is an outcome measure for participants with anorexia nervosa, binge/purge type	Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment

Collaborators and Investigators

• Sponsor: Drexel University
• Collaborators: National Institute of Mental Health (NIMH)

Publications and helpful links

Helpful Links

• For more information, send an email to EDresearch@drexel.edu or call (215) 553-7130

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2020
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Bulimia Nervosa; Binge Eating; Eating Disorders; Binge Eating Disorder; Mindfulness and Acceptance Based Behavioral Treatments; Anorexia Nervosa Binge/Purge Type
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Anorexia; Anorexia Nervosa; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa
• Other Study ID Numbers: 2001007570

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No