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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:
Participants will be asked to do the following steps:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
self-identify as female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Phoenix | Arizona | 85004 | United States |
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| 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. |
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| 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. |
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| 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) |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D002032 | Bulimia |
| D000856 | Anorexia Nervosa |
| D056912 | Binge-Eating Disorder |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D006963 | Hyperphagia |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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