We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
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 : September 22, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Drexel University

Tracking Information
First Submitted Date  ICMJE September 16, 2020
First Posted Date  ICMJE November 12, 2020
Last Update Posted Date September 22, 2021
Actual Study Start Date  ICMJE June 5, 2020
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2020)
  • 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
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2020)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimizing Mindfulness and Acceptance Based Behavioral Treatment for Bulimia Nervosa and Binge Eating Disorder
Official Title  ICMJE Optimizing Mindfulness and Acceptance Based Behavioral Treatment for Bulimia Nervosa and Binge Eating Disorder
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
MOST: multiphase optimization strategy
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Bulimia Nervosa
  • Bulimia; Atypical
  • Binge-Eating Disorder
  • Binge-Eating and Purging Type Anorexia Nervosa
  • Binge Eating
Intervention  ICMJE
  • 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).
  • 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.
Study Arms  ICMJE
  • Active Comparator: Base BT
    16 weekly sessions of behavioral therapy.
    Intervention: Behavioral: Behavioral Therapy for Eating Disorders
  • Experimental: Base BT + Distress Tolerance
    16 weekly sessions of behavioral therapy with distress tolerance components of MABTs.
    Intervention: Behavioral: MABT: Distress Tolerance
  • Experimental: Base BT + Emotion Regulation
    16 weekly sessions of behavioral therapy with emotion regulation components of MABTs.
    Intervention: Behavioral: MABT: Emotion Modulation
  • Experimental: Base BT + Mindful Awareness
    16 weekly sessions of behavioral therapy with mindful awareness components of MABTs.
    Intervention: Behavioral: MABT: Mindful Awareness
  • Experimental: Base BT + Values
    16 weekly sessions of behavioral therapy with values components of MABTs.
    Intervention: 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • Behavioral: MABT: Mindful Awareness
    • Behavioral: MABT: Values
    • Behavioral: MABT: Emotion Modulation
    • Behavioral: MABT: Distress Tolerance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 10, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2024
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Research Coordinator 215-553-7130 EDresearch@drexel.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04625959
Other Study ID Numbers  ICMJE 2001007570
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Drexel University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Drexel University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE Not Provided
PRS Account Drexel University
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP