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

NCT04625959 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2023-09-25

No results posted yet for this 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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Drexel University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-05
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04625959 on ClinicalTrials.gov