Improving digital health tools for treating bulimia and binge eating disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effects of different self-monitoring and micro-intervention strategies combined with cognitive behavioral therapy (CBT) for individuals with bulimia nervosa and binge eating disorder. Participants will be assigned to one of six treatment conditions that vary in the complexity of self-monitoring and micro-interventions. The study will assess the optimal complexity of these interventions on eating pathology at various follow-up points. Additionally, it will explore how these complexities interact with participants' baseline self-regulation deficits to influence treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Are 18 to 65 years old.
2. Have experienced 12 or more loss of control episodes within the previous 3 months.
3. Have a BMI above 18.5.
4. Are located in the US and willing/able to participate in remote treatment and assessments.
5. Have a smartphone.
6. Complete the three-day app trial after the baseline assessment (i.e., the participant shows that they can self-monitor their episodes of eating three times a day for three days).

Exclusion Criteria:

1. Are unable to fluently speak, write and read English.
2. Have a BMI below 18.5.
3. Are already receiving treatment for an eating disorder (e.g., research participants cannot be receiving concurrent eating disorder treatment in the clinical trial and from another provider). Participants willing to pause their existing eating disorder treatment for the duration of the clinical trial are eligible to participate.
4. Are already receiving pharmacological or behavioral treatment for weight loss.
5. If they meet the criteria for PCP clearance (see "Primary care physician clearance" section above) and are not deemed safe for outpatient treatment by a primary care physician.
6. If they meet the criteria for PCP clearance and are unwilling to receive medical clearance and/or medical monitoring as requested by the study to ensure they are medically safe to participate.
7. Have a mental handicap or are experiencing other severe psychopathology that would limit the research participants' ability to comply with the demands of the current study (e.g., imminent suicide risk, active psychotic disorder). Imminent suicide risk is assessed through the C-SSRS and a full risk assessment (see "Plan for assessing and/or intervening on suicidal ideation" above). Active psychotic disorder is assessed during the phone screen and with the standardized assessment checklist.
8. Are using a substance wherein the substance use is creating significant functional impairment that it is unlikely they can safely and effectively participate in an outpatient treatment study for eating pathology (i.e., the substance use: is interfering with day-to-day responsibilities and/or has gotten them in trouble with the law in the past year and/or has prevented them from attending/completing work and/or school within the past year) and/or if they are experiencing medical symptoms related to their substance use that requires immediate treatment and/or are unwilling or refrain from using the substances when it may interfere with treatment sessions and assessments (i.e., unwilling to not use the substances starting 2 hours prior to assessments and treatment sessions). Substance use is assessed during the phone screen and with the standardized assessment checklist.
9. Are pregnant or planning to become pregnant within the next year and a half.

Where it's running

• Nemours Children's Health, Wilmington
  Wilmington, Delaware, United States Recruiting

Study contacts

• Principal investigator: Stephanie Manasse, Ph.D. — Nemours Children's Health
• Study coordinator: Adarsh Javvaji, B.A.
• Email: projectacquire@nemours.org
• Phone: 302-433-1198

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.