Interoceptive exposure intervention for 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 a fully remote intervention targeting self-regulatory factors and eating disorder pathology among adults with binge-spectrum eating disorders. Participants will complete a series of assessments using HIPAA-approved platforms and will engage in a 4-week intervention involving heart rate variability biofeedback or an eating disorder-specific intervention. The study includes a baseline and post-intervention assessment period where participants will provide data through mobile surveys and wear Holter monitors to track heart rate variability. The goal is to understand the effectiveness of these interventions in managing eating disorders.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ages 18-64;
* no changes to ED treatment in the past 4-weeks;
* agree not to access other eating disorder treatments throughout the studies (unless warranted by a worsening of participants' symptoms during the study period; see Monitoring Participant Safety for more information);
* no bariatric surgery (prior or planned during the study period);
* no pregnancy or lactation (current or planned during the study);
* own an Apple or Android-brand iOS smartphone (which is required for compatibility with the apps used in this study;
* reside in the continental U.S.;
* meet Diagnostic and Statistical Manual of Mental Disorders-5-TR (DSM-5-TR) criteria for binge eating disorder (BED) or bulimia nervosa (BN), both of which include objective binge eating (i.e., consuming a larger amount of food than most people would eat in a similar period of time under similar circumstances with loss of control over eating during the episode) ≥1x/week over the past 3 months (APA, 2022). Single-item questions will determine eligibility via criteria 1-7. Criterion 8 for will be determined via the Eating Disorder Diagnostic Scale for the DSM-5 (EDDS-5; Stice et al., 2000, 2004), which has exhibited good sensitivity (.88), specificity (.98), and positive predictive power (.74) for detecting EDs among community samples (Stice et al., 2000, 2004).

Exclusion Criteria:

* not between the ages of 18 and 64;
* had changes to ED treatment in the past 4 weeks;
* plan to access other eating disorder treatments throughout the study;
* received or are planning to undergo bariatric surgery during the study period;
* currently pregnant or lactating, or planning to become pregnant or lactate during the study period;
* no Apple or Android-brand iOS smartphone;
* do not live in the continental U.S.;
* do not currently experience BN or BED.

Where it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Carol Peterson, MD — University of Minnesota
• Study coordinator: Kelly Romano, PhD
• Email: kromano@umn.edu

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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.