HRV-bio + ED-JITAI for Eating Disorder
Trial Summary
What is the purpose of this trial?
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-day EMA assessment period while they also wear the Holter monitors. Recruitment is expected to last for 1.5 years. In HRV-bio, participants will also complete a HRV biofeedback task via the Elite HRV app. In this intervention, participants will learn how to use their HRV data that they will see in real-time via the Elite HRV app to improve their HRV by engaging in an app-guided diaphragmatic breathing exercise. They will complete this exercise twice daily (morning, night). In ED-JITAI, participants will be prompted to complete focused, guided body scan tasks that will be sent to them via the MindLogger app. These guided tasks will be sent to them in the form of 1 of 3 brief (3-5 minute) videos via the MindLogger app. The body scans will be designed to promote participants' connection with, vs. distancing/distraction from, feared ED sensations (e.g., hunger, satiety, bloating). Participants will receive prompts to complete the body scans at times when they report via EMA that they are experiencing worse interoception than usual. "Worse interoception than usual" will be defined as participants' EMA-reported interoception scores during the intervention period that fall 1 SD or more above their baseline EMA-reported interoception levels.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must not change your eating disorder treatment during the study unless your symptoms worsen.
What data supports the effectiveness of the treatment HRV-bio + ED-JITAI for eating disorders?
The meta-review indicates that psychotherapy, which may include components similar to ED-JITAI, is effective for binge-eating disorder, and cognitive behavioral therapy (CBT) is effective for bulimia nervosa. These findings suggest that similar therapeutic approaches can be beneficial for eating disorders.12345
How does the HRV-bio + ED-JITAI treatment for eating disorders differ from other treatments?
The HRV-bio + ED-JITAI treatment is unique because it combines heart rate variability biofeedback (HRV-bio) with a just-in-time adaptive intervention (JITAI) specifically designed for eating disorders. This approach is novel as it uses real-time data to provide personalized support and interventions, which is different from traditional therapies like cognitive behavioral therapy that do not typically incorporate biofeedback or adaptive technology.678910
Research Team
Carol Peterson, MD
Principal Investigator
University of Minnesota
Eligibility Criteria
Adults aged 18-64 living in the continental U.S. with binge eating disorder or bulimia nervosa, as defined by DSM-5 criteria, who haven't had bariatric surgery or changes to their eating disorder treatment in the past month. Participants must own a compatible smartphone and not be pregnant, planning pregnancy, or lactating.Inclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline EMA
Participants complete a cross-sectional survey and a 7-day EMA period with Holter monitor usage
Treatment
Participants undergo a 4-week intervention with HRV biofeedback or ED-JITAI treatment
Post-intervention EMA
Participants complete a 7-day EMA assessment period with Holter monitor usage
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ED-JITAI (Behavioural Intervention)
- HRV-bio (Behavioural Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor