The Effects of Heart Rate Variability Biofeedback on College Students With Disordered Eating
NCT Number: NCT06546163
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
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|BEHAVIORAL: Heart rate variability biofeedback|BEHAVIORAL: Educational materials
Sponsor: Arizona State University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 21
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-01-08
Completion Date: 2024-08-01
Locations: Arizona State University, Phoenix, Arizona, 85004, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Changes from Baseline Profile of Mood States (POMS) short version (Psychological Distress) at 2 weeks, Psychological distress will be measured using the Profile of Mood States (POMS) short version (15 items, 5-point Likert scale; 0=not at all, 4=extremely). The POMS is one of the most frequently used and validated scales in studies of psychosocial interventions for cancer patients. The POMS Total Mood Disturbance (TMD) score has been shown to be most sensitive to interventions designed to manage mood or reduce stress. The POMS consists of the TMD dimensions (tension-anxiety; depression-dejection; anger-hostility; and confusion-bewilderment) (Cronbach's a = .93) to be used in the current study as a secondary outcome measure; and two others (fatigue-inertia; vigor-activity) will be documented. Total of Mood Disturbance= (anxious+depression+anger+fatigue)- vigor (Range from 12 to 48). The higher values represent a worse emotional well-being., Baseline (T1), 2 weeks after (T2)|Changes from Baseline on Perceived Stress Scale, Perceived stress will be measured using the Perceived Stress Scale (PSS). (10 items, 5-point Likert scale; 0=never, 4=very often). The PSS is one of the most frequently used and validated scales for stress assessment. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. (Cronbach's a = .82) to be used in the current study as a secondary outcome measure. The higher values represent higher perceived stress., Baseline (T1), 2 weeks after (T2)|Changes from Baseline on Loss of Control eating brief (LOCES-B) Scale, Loss of control over eating will be measured using LOCES-B. It is a 7-item scale, with a 5-point Likert scale; 1= Never, 5=Always). It is a reliable and valid measure of loss of control over eating. (Cronbach's α = .92). Individual scores on LOCES-B can range between 5- 35 with higher scores indicating greater loss of control over eating. Higher scores on the LOCES-B total score indicate greater body image dissatisfaction, more internalizing symptoms, and lower trait effortful control., Baseline (T1), 2 weeks after (T2)|Change from baseline on Eating Disorder Examination Questionnaire, The Eating Disorder Examination Questionnaire (EDE-QS) is a 12-item self-report questionnaire used for the assessment of eating disorder pathology. The EDE-QS has a response scale ranging from 0 to 3 that captures essential symptoms of Anorexia Nervosa, Bulimia Nervosa, and Binge Eating Disorder. The possible range of scores on the scale ranges from 0 to 36 and higher scores indicate greater ED symptoms. ED symptoms are reported for the preceding seven days. Cronbach's alpha obtained in this sample was .91 indicating excellent internal consistency. It is a reliable and valid measure to assess eating disorder pathology., Baseline (T1), 2 weeks after (T2)|Change from baseline on Brief Resilience Scale (BRS), The Brief Resilience Scale is a six-item scale used to measure resilience. The respondents were asked to indicate how well each statement described their behavior and actions on a 5-point Likert-type scale, ranging from "1" = does not describe me at all to "5" = describes me very well. The range of possible scores on BRS is from 6-30. There are three positively worded items and three negatively worded items. The three negative items will be reverse-coded during scoring It is a valid and reliable measure of resilience. (Cronbach's α = .85)., Baseline (T1), 2 weeks after (T2)