HRV-bio + ED-JITAI for Eating Disorder

Overseen By Kelly Romano, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Age, ED treatment changes, Bariatric, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 4 weeks

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore new ways to manage binge eating disorder (BED) and bulimia nervosa (BN) using smartphone apps. Participants will be divided into two groups: one group will use heart rate variability (HRV) biofeedback to practice breathing exercises, while the other will engage in ED-JITAI, which involves guided body scan tasks to help connect better with their bodily sensations. The study seeks individuals who have experienced BED or BN episodes at least once a week for the past three months and own a compatible smartphone.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that heart rate variability biofeedback (HRV-bio) is generally easy for people to handle. A small study found no serious side effects, and most participants found it helpful. This treatment uses a mobile app to guide breathing exercises, which can improve heart rate variability (HRV). Studies have linked HRV to various health conditions, including eating disorders.

For the ED-JITAI treatment, research suggests that just-in-time adaptive interventions (JITAI) offer a promising way to manage eating disorder symptoms. JITAI systems can help track triggers of disordered eating and provide timely support. Research on JITAI has not reported significant safety issues, indicating it is safe for most people.

Both HRV-bio and ED-JITAI use non-invasive methods that are generally safe. Participants in past studies handled these treatments well, with no major adverse effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the HRV-bio and ED-JITAI treatments for eating disorders because they offer innovative approaches compared to conventional therapies like cognitive-behavioral therapy and medication. HRV-bio utilizes heart rate variability biofeedback, which helps patients manage stress and emotional regulation by teaching them to control their physiological responses. On the other hand, ED-JITAI is a Just-In-Time Adaptive Intervention that delivers personalized support via digital technology precisely when the patient needs it. These treatments are promising because they provide real-time, personalized support and stress management techniques, potentially leading to more effective and timely interventions for individuals with eating disorders.

What evidence suggests that this trial's treatments could be effective for eating disorders?

This trial will compare two treatments for eating disorders: HRV biofeedback and ED-JITAI. Research has shown that heart rate variability (HRV) biofeedback, which participants in Group 1 will receive, can help with stress-related issues, including those linked to eating disorders. HRV biofeedback involves slow, calming breathing, which has shown promise in helping people manage their emotions better. Studies have found it effective in promoting relaxation and reducing anxiety in individuals with eating disorders.

Participants in Group 2 will receive Just-In-Time Adaptive Interventions (JITAI). JITAI uses timely reminders to help manage eating disorder symptoms. It has been shown to assist in real-time, improving how individuals respond to their needs and feelings. This method is particularly helpful for those who struggle to recognize hunger or fullness, making it a promising approach for treating eating disorders. ^{1 2 3 6 7}

Who Is on the Research Team?

Carol Peterson, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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 am not pregnant or breastfeeding, nor do I plan to be during the study.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Group 2 Experimental Treatment 1 Intervention

Randomized to ED-JITAI treatment

Group II: Group 1 Experimental Treatment 1 Intervention

randomized to HRV bio

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

This study is the first randomized controlled trial in Japan evaluating enhanced cognitive behavior therapy (CBT-E) for bulimia nervosa (BN), involving 140 adult outpatients and comparing CBT-E to treatment as usual (TAU) over 20 weeks.

If CBT-E proves more effective than TAU, it could lead to broader implementation of this therapy for BN in Japan, highlighting its potential adaptability to different cultures and increasing accessibility for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of enhanced cognitive behavior therapy for bulimia nervosa in Japan: a randomized controlled trial protocol. Ohara, C., Sekiguchi, A., Takakura, S., et al.[2022]

In a study of 80 adults undergoing psychological treatment for bulimia nervosa, objective binge eating (OBE) episodes decreased twice as quickly as subjective binge eating (SBE) episodes, indicating different trajectories in eating behaviors during treatment.

Reductions in the frequency of SBE were linked to improvements in eating-related psychopathology, depression, and anxiety, suggesting that addressing subjective binge eating may be crucial for enhancing overall mental health outcomes in bulimia nervosa treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between objective and subjective binge eating and psychopathology during a psychological treatment trial for bulimic symptoms. Goldschmidt, AB., Accurso, EC., Crosby, RD., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid response in psychological treatments for binge eating disorder. Hilbert, A., Hildebrandt, T., Agras, WS., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 92 female patients, the probability of remission after 5 years was high, with 74% for bulimia nervosa and 83% for EDNOS, indicating that both conditions have a favorable long-term outcome.

The presence of personality disorders did not significantly affect the likelihood of remission or relapse in patients with bulimia nervosa or EDNOS, suggesting that these eating disorders can be treated effectively regardless of co-occurring personality issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Grilo, CM., Pagano, ME., Skodol, AE., et al.[2022]

A modified form of interpersonal therapy (IPT-BNm) was effective in treating 59 patients with Bulimia Nervosa (BN) and Eating Disorders Not Otherwise Specified (EDNOS), showing significant improvements in eating disorder symptoms, interpersonal functioning, and depression levels by the middle of treatment.

Patients experienced notable reductions in bingeing and self-induced vomiting within the first eight sessions, indicating that IPT-BNm works quickly to alleviate symptoms of bulimia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case series evaluation of a modified version of interpersonal psychotherapy (IPT) for the treatment of bulimic eating disorders: a pilot study. Arcelus, J., Whight, D., Langham, C., et al.[2022]

Cognitive behavioral therapy for eating disorders (CBT-ED) is shown to be more effective than other treatments for bulimia nervosa (BN) and binge eating disorder (BED), while interpersonal psychotherapy is equally effective for BED.

Current evidence does not support the effectiveness of CBT-ED for adult anorexia nervosa (AN) and is lacking for adolescents, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for the Eating Disorders. Agras, WS., Bohon, C.[2022]

Enhanced Cognitive Behavioral Therapy (CBT-E) shows promise in treating a range of eating disorders, including anorexia nervosa and bulimia nervosa, based on a review of six studies, although the evidence is still considered tentative as CBT-E is in early testing phases.

CBT-E is unique because it tailors treatment to the specific symptoms of individual clients rather than applying a one-size-fits-all approach, making it a potentially effective option for those with chronic eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is enhanced cognitive behavioral therapy an effective intervention in eating disorders? A review. Groff, SE.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological therapies for eating disorders. Mitchell, JE., Roerig, J., Steffen, K.[2021]

Family-based therapy (FBT) is particularly effective for treating anorexia nervosa in both adults and adolescents, outperforming active control treatments.

Cognitive behavioral therapy for eating disorders (CBT-ED) shows the broadest efficacy for bulimia nervosa in adults, while antidepressants also demonstrate effectiveness, although with lower acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of eating disorders: A systematic meta-review of meta-analyses and network meta-analyses. Monteleone, AM., Pellegrino, F., Croatto, G., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6492029/

Just-in-time adaptive interventions: A novel approach for ... The current article discusses how novel JITAI systems that utilize machine learning or other predictive algorithms could be used to detect momentary risk for ...

2. formative.jmir.org formative.jmir.org/2021/5/e18261/

A Clinician-Controlled Just-in-time Adaptive Intervention ... We also present feasibility, acceptability, and preliminary outcomes data from a small proof-of-concept pilot trial (n=5 patients and n=3 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30051495/

Just-in-time adaptive interventions: A novel approach for ... The current article discusses how novel JITAI systems that utilize machine learning or other predictive algorithms could be used to detect momentary risk for ...

4. researchgate.net researchgate.net/publication/326651513_Just-in-time_adaptive_interventions_A_novel_approach_for_enhancing_skill_utilization_and_acquisition_in_cognitive_behavioral_therapy_for_eating_disorders

(PDF) Just‐in‐time adaptive interventions: A novel ... The current article discusses how novel JITAI systems that utilize machine learning or other predictive algorithms could be used to detect momentary risk for ...

5. researchprotocols.org researchprotocols.org/2025/1/e58917

Just-In-Time Adaptive Interventions to Promote Behavioral ... This study aims to systematically review the literature to describe the landscape of existing JITAIs for behavioral health at any stage of intervention ...

6. frontiersin.org frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2025.1460167/pdf?utm_source=consensus

Beyond the current state of just-in-time adaptive ... Results: Of the 1,419 records initially screened, 9 papers reporting on 5 JITAIs were included (sample size range: 5 to an expected 264). Two ...

7. mental.jmir.org mental.jmir.org/2024/1/e48974

Toward Tailoring Just-in-Time Adaptive Intervention Systems ... This study aims to identify key tailoring variables that influence momentary engagement in digital stress reduction microinterventions to inform the design of ...