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

Bulimia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04625959
• Other study ID #: 2001007570
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: April 2024

Study information

• Verified date: September 2023
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 256
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Binge Eating
• Binge-Eating and Purging Type Anorexia Nervosa
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Bulimia; Atypical
• Feeding and Eating Disorders

Intervention

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).
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Drexel University, Stratton Hall	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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

External Links

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