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Behavioral Intervention

App-Based Mindfulness Training for Eating Disorders

N/A

Recruiting

Research Sponsored by Yeshiva University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Meet diagnostic DSM 5 diagnostic criteria for anorexia nervosa, bulimia nervosa, or atypical anorexia nervosa/bulimia nervosa

Must not have

Current untreated psychotic or bipolar disorder

BMI <15 or medically unstable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to post-treatment(8-weeks) and through 2-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess an 8-week digital mindfulness-based program to help people with anorexia and bulimia. It'll then measure its effectiveness in a randomized controlled trial. #clinicaltrial

Who is the study for?

This trial is for adults over 18 who have been diagnosed with anorexia nervosa or bulimia according to DSM 5 criteria. Participants must be able to read and write in English, own a smartphone, have completed at least one month of eating disorder treatment, and are currently receiving outpatient treatment. They cannot join if they have untreated psychotic or bipolar disorders, drug/alcohol dependence, severe underweight (BMI <15), are medically unstable or in residential/inpatient care.

What is being tested?

The study tests 'Mindful Courage', an app-based mindfulness training program lasting eight weeks designed for individuals with anorexia nervosa and bulimia nervosa. It's a single-arm trial aimed at assessing the acceptability and feasibility before moving on to a randomized control trial phase.

What are the potential side effects?

Since this intervention involves mindfulness training through an app, there may not be direct physical side effects like those associated with medication; however, participants might experience emotional discomfort or distress while engaging in self-reflection during the exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with anorexia, bulimia, or a related eating disorder.

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I have completed at least one month of treatment for an eating disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have untreated psychotic or bipolar disorder.

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My BMI is under 15 or I am medically unstable.

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I am currently in a hospital or residential treatment program.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to post-treatment(8-weeks) and through 2-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to post-treatment(8-weeks) and through 2-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to post-treatment(8-weeks) and through 2-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability dimensions

Feasibility

Secondary study objectives

Change in Body Dissatisfaction

Change in Eating Disorder Symptoms

Change in Emotion Dysregulation

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Mindful CourageExperimental Treatment1 Intervention

Mindful Courage is a digital intervention including mindfulness and cognitive behavioral elements for individuals with anorexia nervosa or bulimia nervosa. Mindful Courage will consist of 8-weeks of self-guided modules which will be completed over the course of 8 weeks. Elements included in the intervention include psychoeducation, self-monitoring, regular eating, body image, values clarification, and mindful awareness and acceptance. Participants learn a range mindfulness skills and practice a range of mindfulness meditations. Participants will also receive phone coaching. Homework consists of meditation practices.

0 / 6Eligibility criteria met