144 Participants Needed

HRV-bio + ED-JITAI for Eating Disorder

EF
KR
Overseen ByKelly Romano, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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

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.

Research Team

CP

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

I haven't changed my erectile dysfunction treatment in the last 4 weeks.
I agree not to seek other eating disorder treatments during the study, unless my condition worsens.
I have not had, nor do I plan to have, weight-loss surgery.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
Virtual screening via Qualtrics

Baseline EMA

Participants complete a cross-sectional survey and a 7-day EMA period with Holter monitor usage

1 week
6 daily surveys via MindLogger app

Treatment

Participants undergo a 4-week intervention with HRV biofeedback or ED-JITAI treatment

4 weeks
Daily app-guided exercises

Post-intervention EMA

Participants complete a 7-day EMA assessment period with Holter monitor usage

1 week
6 daily surveys via MindLogger app

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • ED-JITAI
  • HRV-bio
Trial Overview The study tests two remote interventions for eating disorders: HRV-biofeedback using an app to guide breathing exercises aimed at improving heart rate variability; and ED-JITAI which involves guided body scans via an app when experiencing intense sensations like hunger.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
Randomized to ED-JITAI treatment
Group II: Group 1Experimental Treatment1 Intervention
randomized to HRV bio

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Findings from Research

In a study of 205 adults with binge eating disorder, rapid response (≥70% reduction in binge eating by Week 4) was a strong predictor of long-term remission, particularly in those receiving cognitive-behavioral therapy guided self-help (CBTgsh).
While rapid responders in CBTgsh showed sustained remission and lower eating disorder psychopathology, interpersonal psychotherapy (IPT) was equally effective for both rapid and nonrapid responders, suggesting it could be a valuable second-line treatment for those who do not respond quickly to CBTgsh.
Rapid response in psychological treatments for binge eating disorder.Hilbert, A., Hildebrandt, T., Agras, WS., et al.[2022]
Antidepressants, especially SSRIs, are effective in reducing symptoms of bulimia nervosa, while various medications can help decrease binge eating frequency in binge eating disorder, though they have only modest effects on weight.
The treatment options for anorexia nervosa are limited, with few controlled trials showing disappointing results for atypical antipsychotics, highlighting the need for more research in pharmacological therapies for eating disorders.
Biological therapies for eating disorders.Mitchell, JE., Roerig, J., Steffen, K.[2021]
Remission rates for eating disorders varied significantly based on the definition used, ranging from 13.2% to 40.5% for anorexia nervosa (AN), 15.0% to 47.6% for bulimia nervosa (BN), and 24.2% to 53.1% for eating disorder not otherwise specified (EDNOS) among 195 women studied.
Patients who achieved remission reported a higher quality of life across various domains, suggesting that remission not only improves psychological well-being but also aligns quality of life scores with those of individuals without eating disorders.
What does remission tell us about women with eating disorders? Investigating applications of various remission definitions and their associations with quality of life.Ackard, DM., Richter, SA., Egan, AM., et al.[2018]

References

Rapid response in psychological treatments for binge eating disorder. [2022]
Biological therapies for eating disorders. [2021]
What does remission tell us about women with eating disorders? Investigating applications of various remission definitions and their associations with quality of life. [2018]
A case series evaluation of a modified version of interpersonal psychotherapy (IPT) for the treatment of bulimic eating disorders: a pilot study. [2022]
Treatment of eating disorders: A systematic meta-review of meta-analyses and network meta-analyses. [2023]
Is enhanced cognitive behavioral therapy an effective intervention in eating disorders? A review. [2022]
Cognitive Behavioral Therapy for the Eating Disorders. [2022]
Natural course of bulimia nervosa and of eating disorder not otherwise specified: 5-year prospective study of remissions, relapses, and the effects of personality disorder psychopathology. [2022]
Effectiveness of enhanced cognitive behavior therapy for bulimia nervosa in Japan: a randomized controlled trial protocol. [2022]
Association between objective and subjective binge eating and psychopathology during a psychological treatment trial for bulimic symptoms. [2018]
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