Trials / Completed

CompletedNCT06546163

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

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 21 (actual)

Sponsor: Arizona State University · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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
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.
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.

Timeline

Start date: 2024-01-08
Primary completion: 2024-06-16
Completion: 2024-08-01
First posted: 2024-08-09
Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06546163. Inclusion in this directory is not an endorsement.