Interoceptive exposure intervention for binge eating disorders

Targeting Transdiagnostic Self-regulatory Factors and Eating Disorder Pathology Among Adults With BInge-spectrum Eating disOrders: A mHEALTH Interoceptive Exposure Intervention (the Bio-HEALTH Study)

This study is testing a new online program to help adults with binge eating disorders by using techniques to manage their emotions and eating habits over four weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: University of Minnesota (Academic / other)
• Locations: 1 site (Minneapolis, Minnesota)
• Trial ID: NCT06631729 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-64 who meet the DSM-5-TR criteria for binge eating disorder or bulimia nervosa and have not changed their eating disorder treatment in the past month.

Not a fit: Patients who are currently pregnant, lactating, or have undergone bariatric surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could provide a novel approach to managing binge eating disorders, potentially improving patients' self-regulation and overall mental health.

How similar studies have performed: While similar interventions targeting eating disorders have shown promise, this specific approach utilizing mobile health technology and interoceptive exposure is relatively novel.

Eligibility criteria

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 this trial is running

Minneapolis, Minnesota

• University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Carol Peterson, MD — University of Minnesota
• Study coordinator: Kelly Romano, PhD

Conditions Eating Disorders