Optimizing Mindfulness and Acceptance Based Behavioral Treatment for Bulimia Nervosa and Binge Eating Disorder
September 21, 2023 updated by: Drexel University
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
Study Type
Interventional
Enrollment (Actual)
256
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Drexel University, Stratton Hall
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Base BT
16 weekly sessions of behavioral therapy.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
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.
|
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.
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.
|
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.
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.
|
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 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.
|
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.
|
|
Experimental: Base BT + Emotion Modulation and Values
16 weekly sessions of behavioral therapy with emotion regulation and values components of MABTs.
|
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 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.
|
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.
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 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.
|
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.
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 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.
|
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.
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.
|
|
Experimental: Base BT + ER, MA, and V
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and values components of MABTs.
|
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 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.
|
|
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.
|
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.
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Binge eating frequency 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
|
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
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
|
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
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
|
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)
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
|
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
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
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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