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

NCT06546163 | Completed

• 1 other identifier: STUDY00018977
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Psychosocial health; Heart rate variability biofeedback; Eating disorder; College students

Outcome Measures

Primary Outcomes (1)

• Changes from Baseline Heart Rate Variability (HRV and coherence scores) at 2 weeks

  The Emwave Pro Plus device from HeartMath will be used to collect HRV data and heart rate using a 3-minutes "neutral" protocol (we call "waiting at the bus stop" implying that no particular intent for breath or mindful state is to be evoked) to understand the benefits of HRVB. In addition, HRV measures will be obtained for the 1-minute paced breathing period to understand the effects of paced breathing on HRV. The following precautions will be provided as instructions to participants prior to data collection: no coffee, tea, or caffeinated drinks such as energizing drinks in the 2 hours before the data collection, and no alcohol consumption during 24 hours prior to the data collection.

  Baseline (T1), 2 weeks after (T2)

Secondary Outcomes (5)

• Changes from Baseline Profile of Mood States (POMS) short version (Psychological Distress) at 2 weeks

  Baseline (T1), 2 weeks after (T2)

• Changes from Baseline on Perceived Stress Scale

  Baseline (T1), 2 weeks after (T2)

• Changes from Baseline on Loss of Control eating brief (LOCES-B) Scale

  Baseline (T1), 2 weeks after (T2)

• Change from baseline on Eating Disorder Examination Questionnaire

  Baseline (T1), 2 weeks after (T2)

• Change from baseline on Brief Resilience Scale (BRS)

  Baseline (T1), 2 weeks after (T2)

Study Arms (2)

Baseline and HRVB group

EXPERIMENTAL

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.

Behavioral: Baseline survey; Behavioral: Heart rate variability biofeedback

Baseline and HRVB waitlist

OTHER

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.

Behavioral: Baseline survey; Behavioral: Educational materials

Interventions

Baseline survey 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

Also known as: Baseline questionnaire

Baseline and HRVB group; Baseline and HRVB waitlist

Heart rate variability biofeedback 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 group

Educational materials 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.

Baseline and HRVB waitlist

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: self-identify as female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders; Bulimia; Anorexia Nervosa; Binge-Eating Disorder; Emotional Regulation

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Hyperphagia; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: January 8, 2024
• Primary Completion: June 16, 2024
• Study Completion: August 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)