The Effects of Heart Rate Variability Biofeedback on College Students With Disordered Eating

NCT ID: NCT06546163

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2024-08-01

Brief Summary

The goal of this clinical trial study is to test the heart rate variability biofeedback training in female college students with eating disorders and compare the results between intervention and control group. The main questions it aims to answer are:

• How does heart rate variability biofeedback (HRVB) training impact behaviors related to eating disorders (EDs) and the perceived stress associated with these behaviors?
• What difference are observed in the quality of life and stress responses between individuals trained in HRVB protocol and those in the wait list condition?
• Does HRVB training enhance heart resilience and improve the ability to cope with psychosocial stressors in young women with eating disorders, compared to those in the wait list condition?

Participants will be asked to do the following steps:

• Baseline heart rate variability assessment and completion of the baseline questionnaire
• HRVB training session and two weeks of at-home HRVB practice-10 minutes daily, (intervention group)
• Post-intervention questionnaire completion and heart rate variability assessment
• Optional interview (for intervention group) and HRVB training session (for control group)

Researchers will compare the results of intervention group with control group to see if the participants improve in levels of emotional health, quality of life, and resilience.

Detailed Description

This study is a randomized controlled trial aimed at examining the effect of Heart Rate Variability Biofeedback (HRVB) in female college students with eating disorders. The primary objective of the study is to determine whether HRVB can positively impact the psychosocial health and well-being.

Participants are the female college students aged 18 and above. The number of 30 female college students will participate in the study and they will be randomly assigned to either the HRVB intervention group or the control group (15 for each group). Total Duration of the study will be 2 weeks from the time of enrollment to completion.

Participants are required to visit the lab twice - for baseline and final data collection. They undergo initial assessments before any intervention, including a 3- minute baseline HRV assessment (Using the HeartMath Pro Plus device equipped with an ear or finger sensor), and questionnaires about mood states, stress levels, and eating behaviors. The intervention group will receive instructions to practice HRVB and practice it at home for 10 minutes daily over a two-week period, totaling approximately 140 minutes. They will receive a routine calls/texts/email from the research team as a reminder to practice HRVB sessions as well. Final Data Collection will be done at the end of the two-week intervention period for both groups. Participants from the intervention group will have the option to participate in a brief interview to provide feedback on their experiences with the HRVB intervention, and those in control group will receive HRVB training.

All procedure is designed to prioritize participant comfort and privacy, with informed consent being a crucial part of the enrollment process.

Conditions

Eating Disorders; Eating, Binge; Anorexia Nervosa/Bulimia; Eating Disorder Binge; Heart Rate Variability; Psychological Distress; Emotion Regulation; Autonomic Nervous System

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Baseline and HRVB group

In-person baseline surveys (using paper and pen survey) before the random assignment to HRVB arm. This group will receive a standardized HeartMath© Inner balance device and HRV biofeedback training session at the start of the two-week intervention period. They will be asked to attend one-on-one 30-minute HRVB training session and asked to practice their HRV biofeedback skills at home for 10 minutes each day for a two-week period. Participants will receive a weekly email notification and reminder phone call to complete their at-home practice of HRVB.

Group Type: EXPERIMENTAL

Baseline survey

Intervention Type: BEHAVIORAL

Baseline surveys contains a series of scaled questions, including sociodemographic variable (age, sex, etc), profile of mood states, perceived stress scale, Eating Loss of Control scale, Eating Disorder Examination Questionnaire, Brief Resilience Scale- BRS,Heart Rate Variability and coherence measures

Heart rate variability biofeedback

Intervention Type: BEHAVIORAL

Participants randomized to the intervention arm will receive a standardized HRV sensor and accompanying smartphone app, and a 30-minute HRVB training to use the biofeedback signals to generate a resonant frequency pattern of HRV (coherence) after collecting data at baseline in person. Participants will be asked to practice their HRVB skills at home for 10 minutes for two weeks.

Baseline and HRVB waitlist

In-person baseline surveys (using paper and pen surveys) before the random assignment to HRVB waitlist group. After the baseline data collection, for two weeks, they will be provided educational material regarding education materials and coping with stress and they will be encouraged to read them during the two weeks. At the end of the two-week period, participants will be scheduled for a final in-person session including T2 survey and HRV assessment. They will be also provided HRVB training session at T2.

Group Type: OTHER

Baseline survey

Intervention Type: BEHAVIORAL

Baseline surveys contains a series of scaled questions, including sociodemographic variable (age, sex, etc), profile of mood states, perceived stress scale, Eating Loss of Control scale, Eating Disorder Examination Questionnaire, Brief Resilience Scale- BRS,Heart Rate Variability and coherence measures

Educational materials

Intervention Type: BEHAVIORAL

Participants randomized to the waitlist control arm will receive educational materials on eating disorders and stress management and will be sent home with these materials after completing the baseline survey. They will be encouraged to read the materials over the next two weeks before coming in for T2 survey.

Interventions

Baseline survey

Baseline surveys contains a series of scaled questions, including sociodemographic variable (age, sex, etc), profile of mood states, perceived stress scale, Eating Loss of Control scale, Eating Disorder Examination Questionnaire, Brief Resilience Scale- BRS,Heart Rate Variability and coherence measures

Intervention Type: BEHAVIORAL

Heart rate variability biofeedback

Participants randomized to the intervention arm will receive a standardized HRV sensor and accompanying smartphone app, and a 30-minute HRVB training to use the biofeedback signals to generate a resonant frequency pattern of HRV (coherence) after collecting data at baseline in person. Participants will be asked to practice their HRVB skills at home for 10 minutes for two weeks.

Intervention Type: BEHAVIORAL

Educational materials

Participants randomized to the waitlist control arm will receive educational materials on eating disorders and stress management and will be sent home with these materials after completing the baseline survey. They will be encouraged to read the materials over the next two weeks before coming in for T2 survey.

Intervention Type: BEHAVIORAL

Other Intervention Names

Baseline questionnaire

Eligibility Criteria

Inclusion Criteria

• self-identify as female
• be 18 years of age or older
• be currently enrolled as a college student at ASU
• have experienced or are currently experiencing an eating problem.

Exclusion Criteria

• have major medical or psychiatric illness
• have conditions that could interfere with HRV data accuracy, such as medications affecting heart rhythm, those with a pacemaker or heart transplant
• use of medications affecting eating

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Sunny Wonsun Kim, Ph.D

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Arizona State University

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

STUDY00018977

Identifier Type: -

Identifier Source: org_study_id