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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to post-treatment(8-weeks) and through 2-month follow-up
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability dimensions
Feasibility
Secondary outcome measures
Change in Body Dissatisfaction
Change in Eating Disorder Symptoms
Change in Emotion Dysregulation
+3 more

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.

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Who is running the clinical trial?

Yale UniversityOTHER
1,848 Previous Clinical Trials
2,737,798 Total Patients Enrolled
1 Trials studying Anorexia Nervosa
7 Patients Enrolled for Anorexia Nervosa
Yeshiva UniversityLead Sponsor
7 Previous Clinical Trials
2,197 Total Patients Enrolled

Media Library

Mindful Courage (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05753410 — N/A
Anorexia Nervosa Research Study Groups: Mindful Courage
Anorexia Nervosa Clinical Trial 2023: Mindful Courage Highlights & Side Effects. Trial Name: NCT05753410 — N/A
Mindful Courage (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05753410 — N/A

Frequently Asked Questions

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

Are there still vacancies for participants in this experiment?

"According to the data housed on clinicaltrials.gov, this research trial is actively recruiting subjects. The project was first uploaded on March 1st 2023 and last revised two days later."

Answered by AI

How many individuals have volunteered for this clinical experiment?

"Affirmative. Evidence hosted on clinicaltrials.gov verifies this medical trial's active recruitment, which began on March 1st 2023 and was most recently updated on the 2nd of that month. The study requires twenty participants to be secured from one site."

Answered by AI

What outcomes is this clinical trial expecting to attain?

"During the 8-week treatment, Acceptability dimensions will be monitored as the primary outcome. Other objectives include tracking changes in Emotion Dysregulation (measured on Difficulties in Emotion Regulation Short Form with scores from 1 to 5), Body Dissatisfaction (measured on Body Shape Questionnaire ranging from 34 to 204), and Savoring Beliefs (assessed using Savoring Beliefs Inventory scoring -72 to 72)."

Answered by AI
~10 spots leftby Apr 2025