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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)

RecruitingNAAges 18 Years - 64 YearsAllUniversity of Minnesota
NCT06631729 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The present study will be fully remote (virtual) and include observational design features (assessments) plus a clinical trial. All assessments will be completed using HIPAA-approved platforms (e.g., Qualtrics, MindLogger EMA platform). After screening via Qualtrics to determine eligibility (described below), participants will complete a cross-sectional survey via Qualtrics, followed by a baseline EMA period. During the baseline EMA period, participants will receive brief (3-5 minutes) surveys on their mobile devices 6 times per day for 7-days via the MindLogger app. During the baseline EMA period, participants will also be asked to wear non-invasive chest-worn Holter monitors (Polar H10 Holter monitors) that will capture their heartrate variability data. They will then complete the 4-week intervention (HRV bio or ED-JITAI treatment arms; see below), followed by a post-intervention 7-da

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📋 Eligibility rules (as published)
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.
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What it tests

  • HRV-bio
  • ED-JITAI
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Where

1 site
University of Minnesota
Minneapolis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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