CClinicalTrials.gg
Active, not recruitingNCT04625959Updated Sep 25, 2023

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

An interventional study of Behavioral Therapy for Eating Disorders and MABT: Mindful Awareness in Bulimia Nervosa, Bulimia; Atypical and Binge-Eating Disorder, sponsored by Drexel University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-09-25.

Sponsored by Drexel University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as active, not recruiting.
  • Registered 3 months after the study started (first participant enrolled Jun 2020, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
256
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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).

02

Conditions studied

  • 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
03

In context

Anorexia

411 studies on the registry are indexed under Anorexia; 67 are open to participants now.

This study's enrollment of 256 is above the median of 41 across 287 interventional studies indexed under Anorexia.

Browse Anorexia studies →

Lead sponsor

Drexel University is the lead sponsor of 110 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
256 participants (actual)

Study arms

  • Active comparator
    Base BT

    16 weekly sessions of behavioral therapy.

    Behavioral: Behavioral Therapy for Eating Disorders

  • Experimental
    Base BT + Distress Tolerance

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

    Behavioral: MABT: Distress Tolerance

  • Experimental
    Base BT + Emotion Regulation

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

    Behavioral: MABT: Emotion Modulation

  • Experimental
    Base BT + Mindful Awareness

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

    Behavioral: MABT: Mindful Awareness

  • Experimental
    Base BT + Values

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

    Behavioral: MABT: Values

  • 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: Emotion Modulation · Behavioral: MABT: Distress Tolerance

  • 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: Mindful Awareness · Behavioral: MABT: Distress Tolerance

  • Experimental
    Base BT + Distress Tolerance and Values

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

    Behavioral: MABT: Values · Behavioral: MABT: Distress Tolerance

  • 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: Mindful Awareness · Behavioral: MABT: Emotion Modulation

  • 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 · Behavioral: MABT: Values

  • Experimental
    Base BT + Emotion Modulation and Values

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

    Behavioral: MABT: Values · Behavioral: MABT: Emotion Modulation

  • 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: Mindful Awareness · Behavioral: MABT: Emotion Modulation · Behavioral: MABT: Distress Tolerance

  • 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: Values · Behavioral: MABT: Emotion Modulation · Behavioral: MABT: Distress Tolerance

  • 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: Mindful Awareness · Behavioral: MABT: Values · Behavioral: MABT: Distress Tolerance

  • 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: Mindful Awareness · Behavioral: MABT: Values · Behavioral: MABT: Emotion Modulation

  • 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: Mindful Awareness · Behavioral: MABT: Values · Behavioral: MABT: Emotion Modulation · Behavioral: MABT: Distress Tolerance

Interventions

  • BehavioralBehavioral Therapy for Eating Disorders

    Change behaviors that maintain binge eating (e.g. rigid dietary restriction outside of binge episodes, irregular or chaotic eating patterns).

  • BehavioralMABT: 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.

  • BehavioralMABT: 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.

  • BehavioralMABT: 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.

  • BehavioralMABT: 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.

06

What researchers measure

Primary outcomes

  1. 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

    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

  2. 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.

    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

  3. Remission Status

    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 outcomes

  1. 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

    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

  2. BMI

    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

07

Study locations

1 site
  • Drexel University, Stratton Hall
    Philadelphia, Pennsylvania 19104, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04625959
Lead sponsor
Drexel University
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Nov 12, 2020
Start date
Jun 5, 2020
Primary completion
Apr 2024 (estimated)
Completion
Apr 2024 (estimated)
Last update
Sep 25, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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