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

NCT ID: NCT04625959

Last Updated: 2023-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-05

Study Completion Date

2024-04-30

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

MOST: multiphase optimization strategy
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Base BT

16 weekly sessions of behavioral therapy.

Group Type ACTIVE_COMPARATOR

Behavioral Therapy for Eating Disorders

Intervention Type BEHAVIORAL

Change behaviors that maintain binge eating (e.g. rigid dietary restriction outside of binge episodes, irregular or chaotic eating patterns).

Base BT + Distress Tolerance

16 weekly sessions of behavioral therapy with distress tolerance components of MABTs.

Group Type EXPERIMENTAL

MABT: Distress Tolerance

Intervention Type BEHAVIORAL

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.

Base BT + Emotion Regulation

16 weekly sessions of behavioral therapy with emotion regulation components of MABTs.

Group Type EXPERIMENTAL

MABT: Emotion Modulation

Intervention Type BEHAVIORAL

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.

Base BT + Mindful Awareness

16 weekly sessions of behavioral therapy with mindful awareness components of MABTs.

Group Type EXPERIMENTAL

MABT: Mindful Awareness

Intervention Type BEHAVIORAL

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.

Base BT + Values

16 weekly sessions of behavioral therapy with values components of MABTs.

Group Type EXPERIMENTAL

MABT: Values

Intervention Type BEHAVIORAL

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.

Base BT + Distress Tolerance and Emotion Modulation

16 weekly sessions of behavioral therapy with emotion regulation and distress tolerance components of MABTs.

Group Type EXPERIMENTAL

MABT: Emotion Modulation

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Base BT + Distress Tolerance and Mindful Awareness

16 weekly sessions of behavioral therapy with distress tolerance and mindful awareness components of MABTs.

Group Type EXPERIMENTAL

MABT: Mindful Awareness

Intervention Type BEHAVIORAL

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: Distress Tolerance

Intervention Type BEHAVIORAL

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.

Base BT + Distress Tolerance and Values

16 weekly sessions of behavioral therapy with distress tolerance and values components of MABTs.

Group Type EXPERIMENTAL

MABT: Values

Intervention Type BEHAVIORAL

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: Distress Tolerance

Intervention Type BEHAVIORAL

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.

Base BT + Emotion Modulation and Mindful Awareness

16 weekly sessions of behavioral therapy with emotion regulation and mindful awareness components of MABTs.

Group Type EXPERIMENTAL

MABT: Mindful Awareness

Intervention Type BEHAVIORAL

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: Emotion Modulation

Intervention Type BEHAVIORAL

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.

Base BT + Mindful Awareness and Values

16 weekly sessions of behavioral therapy with values and mindful awareness components of MABTs.

Group Type EXPERIMENTAL

MABT: Mindful Awareness

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Base BT + Emotion Modulation and Values

16 weekly sessions of behavioral therapy with emotion regulation and values components of MABTs.

Group Type EXPERIMENTAL

MABT: Values

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Base BT + EM, DT, MA

16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and distress tolerance components of MABTs.

Group Type EXPERIMENTAL

MABT: Mindful Awareness

Intervention Type BEHAVIORAL

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: Emotion Modulation

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Base BT + DT, ER, and V

16 weekly sessions of behavioral therapy with emotion regulation, distress tolerance, and values components of MABTs.

Group Type EXPERIMENTAL

MABT: Values

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Base BT + DT, MA, and V

16 weekly sessions of behavioral therapy with distress tolerance, mindful awareness, and values components of MABTs.

Group Type EXPERIMENTAL

MABT: Mindful Awareness

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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: Distress Tolerance

Intervention Type BEHAVIORAL

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.

Base BT + ER, MA, and V

16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and values components of MABTs.

Group Type EXPERIMENTAL

MABT: Mindful Awareness

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Base BT + ER, MA, V, DT

16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, distress tolerance, and values components of MABTs.

Group Type EXPERIMENTAL

MABT: Mindful Awareness

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Interventions

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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).

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Drexel University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Drexel University, Stratton Hall

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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2001007570

Identifier Type: -

Identifier Source: org_study_id

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