Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04625959
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : November 12, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Drexel University

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).

Condition or disease Intervention/treatment Phase
Bulimia Nervosa Bulimia; Atypical Binge-Eating Disorder Binge-Eating and Purging Type Anorexia Nervosa Binge Eating Behavioral: Behavioral Therapy for Eating Disorders Behavioral: MABT: Mindful Awareness Behavioral: MABT: Values Behavioral: MABT: Emotion Modulation Behavioral: MABT: Distress Tolerance Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: MOST: multiphase optimization strategy
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Optimizing Mindfulness and Acceptance Based Behavioral Treatment for Bulimia Nervosa and Binge Eating Disorder
Actual Study Start Date : June 5, 2020
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

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: 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: 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 + Distress Tolerance and Mindful Awareness
16 weekly sessions of behavioral therapy with distress tolerance 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: 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 + Distress Tolerance and Values
16 weekly sessions of behavioral therapy with distress tolerance and 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.

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 Modulation and Mindful Awareness
16 weekly sessions of behavioral therapy with emotion regulation 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: 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 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: 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.

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 + EM, DT, MA
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and distress tolerance 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: 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: 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 + DT, ER, and V
16 weekly sessions of behavioral therapy with emotion regulation, distress tolerance, and 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.

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: 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 + DT, MA, and V
16 weekly sessions of behavioral therapy with distress tolerance, mindful awareness, and values 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.

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 + ER, MA, and V
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and values 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.

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 + 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
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.

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: 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.




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04625959


Contacts
Layout table for location contacts
Contact: Research Coordinator 215-553-7130 EDresearch@drexel.edu

Locations
Layout table for location information
United States, Pennsylvania
Drexel University, Stratton Hall Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Research Coordinator    215-553-7130    EDresearch@drexel.edu   
Sponsors and Collaborators
Drexel University
National Institute of Mental Health (NIMH)
Additional Information:
Layout table for additonal information
Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT04625959    
Other Study ID Numbers: 2001007570
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Drexel University:
Mindfulness and Acceptance Based Behavioral Treatments
Eating Disorders
Bulimia Nervosa
Binge Eating Disorder
Anorexia Nervosa Binge/Purge Type
Binge Eating
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Anorexia
Bulimia
Feeding and Eating Disorders
Anorexia Nervosa
Binge-Eating Disorder
Bulimia Nervosa
Pathologic Processes
Mental Disorders
Signs and Symptoms, Digestive
Hyperphagia