Clinical trial NCT06546163: The Effects of Heart Rate Variability Biofeedback on College Students With Disordered Eating
Official title: The Effects of Heart Rate Variability Biofeedback on College Students With Disordered Eating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Changes from Baseline Heart Rate Variability (HRV and coherence scores) at 2 weeks
timeFrame: Baseline (T1), 2 weeks after (T2)
Secondary outcomes:
measure: Changes from Baseline Profile of Mood States (POMS) short version (Psychological Distress) at 2 weeks
timeFrame: Baseline (T1), 2 weeks after (T2)
measure: Changes from Baseline on Perceived Stress Scale
timeFrame: Baseline (T1), 2 weeks after (T2)
measure: Changes from Baseline on Loss of Control eating brief (LOCES-B) Scale
timeFrame: Baseline (T1), 2 weeks after (T2)
measure: Change from baseline on Eating Disorder Examination Questionnaire
timeFrame: Baseline (T1), 2 weeks after (T2)
measure: Change from baseline on Brief Resilience Scale (BRS)
timeFrame: Baseline (T1), 2 weeks after (T2)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References: