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

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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

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.

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

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+

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.

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Rapid response in psychological treatments for binge eating disorder. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Biological therapies for eating disorders. [2021]

3. England 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. [2018]

4. England 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of eating disorders: A systematic meta-review of meta-analyses and network meta-analyses. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Is enhanced cognitive behavioral therapy an effective intervention in eating disorders? A review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for the Eating Disorders. [2022]

8. United States 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Effectiveness of enhanced cognitive behavior therapy for bulimia nervosa in Japan: a randomized controlled trial protocol. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Association between objective and subjective binge eating and psychopathology during a psychological treatment trial for bulimic symptoms. [2018]