ClinicalTrials.Veeva

Menu

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

Drexel University logo

Drexel University

Status

Active, not recruiting

Conditions

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

Treatments

Behavioral: Behavioral Therapy for Eating Disorders
Behavioral: MABT: Emotion Modulation
Behavioral: MABT: Mindful Awareness
Behavioral: MABT: Distress Tolerance
Behavioral: MABT: Values

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04625959
2001007570

Details and patient eligibility

About

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).

Enrollment

256 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

256 participants in 16 patient groups

Base BT
Active Comparator group
Description:
16 weekly sessions of behavioral therapy.
Treatment:
Behavioral: Behavioral Therapy for Eating Disorders
Base BT + Distress Tolerance
Experimental group
Description:
16 weekly sessions of behavioral therapy with distress tolerance components of MABTs.
Treatment:
Behavioral: MABT: Distress Tolerance
Base BT + Emotion Regulation
Experimental group
Description:
16 weekly sessions of behavioral therapy with emotion regulation components of MABTs.
Treatment:
Behavioral: MABT: Emotion Modulation
Base BT + Mindful Awareness
Experimental group
Description:
16 weekly sessions of behavioral therapy with mindful awareness components of MABTs.
Treatment:
Behavioral: MABT: Mindful Awareness
Base BT + Values
Experimental group
Description:
16 weekly sessions of behavioral therapy with values components of MABTs.
Treatment:
Behavioral: MABT: Values
Base BT + Distress Tolerance and Emotion Modulation
Experimental group
Description:
16 weekly sessions of behavioral therapy with emotion regulation and distress tolerance components of MABTs.
Treatment:
Behavioral: MABT: Emotion Modulation
Behavioral: MABT: Distress Tolerance
Base BT + Distress Tolerance and Mindful Awareness
Experimental group
Description:
16 weekly sessions of behavioral therapy with distress tolerance and mindful awareness components of MABTs.
Treatment:
Behavioral: MABT: Mindful Awareness
Behavioral: MABT: Distress Tolerance
Base BT + Distress Tolerance and Values
Experimental group
Description:
16 weekly sessions of behavioral therapy with distress tolerance and values components of MABTs.
Treatment:
Behavioral: MABT: Values
Behavioral: MABT: Distress Tolerance
Base BT + Emotion Modulation and Mindful Awareness
Experimental group
Description:
16 weekly sessions of behavioral therapy with emotion regulation and mindful awareness components of MABTs.
Treatment:
Behavioral: MABT: Emotion Modulation
Behavioral: MABT: Mindful Awareness
Base BT + Mindful Awareness and Values
Experimental group
Description:
16 weekly sessions of behavioral therapy with values and mindful awareness components of MABTs.
Treatment:
Behavioral: MABT: Values
Behavioral: MABT: Mindful Awareness
Base BT + Emotion Modulation and Values
Experimental group
Description:
16 weekly sessions of behavioral therapy with emotion regulation and values components of MABTs.
Treatment:
Behavioral: MABT: Emotion Modulation
Behavioral: MABT: Values
Base BT + EM, DT, MA
Experimental group
Description:
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and distress tolerance components of MABTs.
Treatment:
Behavioral: MABT: Emotion Modulation
Behavioral: MABT: Mindful Awareness
Behavioral: MABT: Distress Tolerance
Base BT + DT, ER, and V
Experimental group
Description:
16 weekly sessions of behavioral therapy with emotion regulation, distress tolerance, and values components of MABTs.
Treatment:
Behavioral: MABT: Emotion Modulation
Behavioral: MABT: Values
Behavioral: MABT: Distress Tolerance
Base BT + DT, MA, and V
Experimental group
Description:
16 weekly sessions of behavioral therapy with distress tolerance, mindful awareness, and values components of MABTs.
Treatment:
Behavioral: MABT: Values
Behavioral: MABT: Mindful Awareness
Behavioral: MABT: Distress Tolerance
Base BT + ER, MA, and V
Experimental group
Description:
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and values components of MABTs.
Treatment:
Behavioral: MABT: Emotion Modulation
Behavioral: MABT: Values
Behavioral: MABT: Mindful Awareness
Base BT + ER, MA, V, DT
Experimental group
Description:
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, distress tolerance, and values components of MABTs.
Treatment:
Behavioral: MABT: Emotion Modulation
Behavioral: MABT: Values
Behavioral: MABT: Mindful Awareness
Behavioral: MABT: Distress Tolerance

Trial contacts and locations

1

Loading...

Central trial contact

Research Coordinator

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems