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

NCT06546163 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Arizona State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-08
Primary Completion
2024-06-16
Completion
2024-08-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06546163 on ClinicalTrials.gov