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Behavioral Therapy for Eating Disorders

N/A
Waitlist Available
Research Sponsored by Drexel University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment
Awards & highlights

Study Summary

This trial is designed to study the independent and combined effects of four components of mindfulness-based behavioral therapy on eating pathology. The four components are Mindful Awareness, Distress Tolerance, Emotion Modulation, and Values-Based Decision Making. The trial will compare the efficacy of each component when used alone and in combination with standard behavioral treatment for bulimia nervosa and binge eating disorder. The primary aim of the study is to evaluate the independent efficacy of each treatment component on eating pathology. Secondary aims are to test the hypotheses that the efficacy of each component is moderated by related baseline deficits in self-regulation, and to quantify the component interaction

Who is the study for?
This trial is for US residents who can participate remotely and consent to treatment. Participants must have had 12 or more episodes of losing control over eating in the past 3 months and a BMI above 16. It's not for those with severe mental health issues, non-English speakers, anyone already receiving eating disorder treatment, or needing immediate medical care.Check my eligibility
What is being tested?
The study tests four behavioral therapy components—Mindful Awareness, Distress Tolerance, Emotion Modulation, Values-Based Decision Making—combined with standard treatment for Bulimia Nervosa (BN) and Binge Eating Disorder (BED). The goal is to see which parts help most with eating disorders by following participants up to one year.See study design
What are the potential side effects?
Behavioral therapies like MABT typically don't cause physical side effects but may bring emotional discomfort as individuals confront difficult emotions and behaviors related to their eating disorders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6-month and 1 year post-treatment follow-up assessment
This trial's timeline: 3 weeks for screening, Varies for treatment, and changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6-month and 1 year post-treatment follow-up assessment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Binge eating frequency assessed by the Eating Disorder Examination
Eating Disorder Examination
Remission Status
Secondary outcome measures
BMI
Compensatory behavior frequency assessed by the Eating Disorder Examination (EDE)

Trial Design

16Treatment groups
Experimental Treatment
Active Control
Group I: Base BT + ValuesExperimental Treatment1 Intervention
16 weekly sessions of behavioral therapy with values components of MABTs.
Group II: Base BT + Mindful Awareness and ValuesExperimental Treatment2 Interventions
16 weekly sessions of behavioral therapy with values and mindful awareness components of MABTs.
Group III: Base BT + Mindful AwarenessExperimental Treatment1 Intervention
16 weekly sessions of behavioral therapy with mindful awareness components of MABTs.
Group IV: Base BT + Emotion RegulationExperimental Treatment1 Intervention
16 weekly sessions of behavioral therapy with emotion regulation components of MABTs.
Group V: Base BT + Emotion Modulation and ValuesExperimental Treatment2 Interventions
16 weekly sessions of behavioral therapy with emotion regulation and values components of MABTs.
Group VI: Base BT + Emotion Modulation and Mindful AwarenessExperimental Treatment2 Interventions
16 weekly sessions of behavioral therapy with emotion regulation and mindful awareness components of MABTs.
Group VII: Base BT + ER, MA, and VExperimental Treatment3 Interventions
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and values components of MABTs.
Group VIII: Base BT + ER, MA, V, DTExperimental Treatment4 Interventions
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, distress tolerance, and values components of MABTs.
Group IX: Base BT + EM, DT, MAExperimental Treatment3 Interventions
16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and distress tolerance components of MABTs.
Group X: Base BT + Distress Tolerance and ValuesExperimental Treatment2 Interventions
16 weekly sessions of behavioral therapy with distress tolerance and values components of MABTs.
Group XI: Base BT + Distress Tolerance and Mindful AwarenessExperimental Treatment2 Interventions
16 weekly sessions of behavioral therapy with distress tolerance and mindful awareness components of MABTs.
Group XII: Base BT + Distress Tolerance and Emotion ModulationExperimental Treatment2 Interventions
16 weekly sessions of behavioral therapy with emotion regulation and distress tolerance components of MABTs.
Group XIII: Base BT + Distress ToleranceExperimental Treatment1 Intervention
16 weekly sessions of behavioral therapy with distress tolerance components of MABTs.
Group XIV: Base BT + DT, MA, and VExperimental Treatment3 Interventions
16 weekly sessions of behavioral therapy with distress tolerance, mindful awareness, and values components of MABTs.
Group XV: Base BT + DT, ER, and VExperimental Treatment3 Interventions
16 weekly sessions of behavioral therapy with emotion regulation, distress tolerance, and values components of MABTs.
Group XVI: Base BTActive Control1 Intervention
16 weekly sessions of behavioral therapy.

Find a Location

Who is running the clinical trial?

Drexel UniversityLead Sponsor
147 Previous Clinical Trials
47,124 Total Patients Enrolled
13 Trials studying Bulimia
958 Patients Enrolled for Bulimia
National Institute of Mental Health (NIMH)NIH
2,774 Previous Clinical Trials
2,674,143 Total Patients Enrolled
34 Trials studying Bulimia
21,917 Patients Enrolled for Bulimia

Media Library

Behavioral Therapy for Eating Disorders Clinical Trial Eligibility Overview. Trial Name: NCT04625959 — N/A
Bulimia Research Study Groups: Base BT, Base BT + Distress Tolerance, Base BT + Emotion Regulation, Base BT + Mindful Awareness, Base BT + Values, Base BT + Distress Tolerance and Emotion Modulation, Base BT + Distress Tolerance and Mindful Awareness, Base BT + Distress Tolerance and Values, Base BT + Emotion Modulation and Mindful Awareness, Base BT + Mindful Awareness and Values, Base BT + Emotion Modulation and Values, Base BT + EM, DT, MA, Base BT + DT, ER, and V, Base BT + DT, MA, and V, Base BT + ER, MA, and V, Base BT + ER, MA, V, DT
Bulimia Clinical Trial 2023: Behavioral Therapy for Eating Disorders Highlights & Side Effects. Trial Name: NCT04625959 — N/A
Behavioral Therapy for Eating Disorders 2023 Treatment Timeline for Medical Study. Trial Name: NCT04625959 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I satisfy the criteria to join this investigation?

"Prospective participants in this clinical trial should have been diagnosed with bulimia nervosa and must be between 18 to 70 years old. A total of 300 individuals will be selected for the trialling period."

Answered by AI

Is this medical trial entertaining applicants of advanced age?

"The minimum age for participation in this trial is 18, with a maximum of 70. However, there are 303 trials that cater to minors and 674 specifically designed for seniors."

Answered by AI

Is enrollment for this investigation still open?

"Affirmative. Clinicaltrials.gov states that this clinical trial, which was initially posted on June 5th 2020 and most recently updated on September 21st 2021, is actively seeking participants. Approximately 300 candidates are required to be recruited from a single location."

Answered by AI

What is the participant enrollment size for this research endeavor?

"Affirmative, the information provided by clinicaltrials.gov confirms that this study is still searching for participants. The trial was initially published on June 5th 2020 and updated recently on September 21st 2021 with a goal of recruiting 300 patients from 1 healthcare site."

Answered by AI

Who else is applying?

What state do they live in?
California
New Jersey
Delaware
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Drexel University, Stratton Hall
How many prior treatments have patients received?
0
~0 spots leftby Apr 2024