Eating DisordersNCT06546163
The Effects of Heart Rate Variability Biofeedback on College Students With Disordered Eating
A study testing Baseline survey, Heart rate variability biofeedback and Educational materials in people with Eating Disorders and Eating, Binge, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Eating Disorders, Eating, Binge, Anorexia Nervosa/Bulimia
- What is being tested?
- Baseline survey, Heart rate variability biofeedback and Educational materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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.
Read the 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
- Eating Disorders, Eating, Binge, Anorexia Nervosa/Bulimia, Eating Disorder Binge, Heart Rate Variability, Psychological Distress
- Being tested
- Baseline survey, Heart rate variability biofeedback, Educational materials
- Keywords
- Psychosocial health, Heart rate variability biofeedback, Eating disorder, College students
- Medical subject headings
- Feeding and Eating Disorders, Bulimia, Anorexia Nervosa, Binge-Eating Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline surveyBehavioural
Also called Baseline questionnaire
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
Heart rate variability biofeedbackBehavioural
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.
Educational materialsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Baseline survey; Behavioral: Heart rate variability biofeedback |
| 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. Receives: Behavioral: Baseline survey; Behavioral: Educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T1), 2 weeks after (T2)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline (T1), 2 weeks after (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start8 Jan 2024
- Primary completion16 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunny Wonsun Kim, Ph.D, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546163
- Sponsor's protocol ID
- STUDY00018977
- Status last verified
- Sep 2024
- First submitted
- 7 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Heart Rate Variability Biofeedback on College Students With Disordered Eating
- ClinicalTrials.gov ID
- NCT06546163
- Acronym / sponsor ID
- STUDY00018977
- Conditions
- Eating Disorders, Eating, Binge, Anorexia Nervosa/Bulimia, Eating Disorder Binge, Heart Rate Variability, Psychological Distress
- Keywords
- Psychosocial health, Heart rate variability biofeedback, Eating disorder, College students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 16 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline and HRVB group | Experimental | Behavioral: Baseline survey, Behavioral: Heart rate variability biofeedbackIn-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. |
| Baseline and HRVB waitlist | Other | Behavioral: Baseline survey, Behavioral: Educational materialsIn-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline surveyAlso: Baseline questionnaireBaseline 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 | Behavioural | Baseline and HRVB group, Baseline and HRVB waitlist |
| Heart rate variability biofeedbackParticipants 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. | Behavioural | Baseline and HRVB group |
| Educational materialsParticipants 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. | Behavioural | Baseline and HRVB waitlist |
Primary outcome
Changes from Baseline Heart Rate Variability (HRV and coherence scores) at 2 weeks
Time frame: Baseline (T1), 2 weeks after (T2)
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.
5 secondary outcomes
Changes from Baseline Profile of Mood States (POMS) short version (Psychological Distress) at 2 weeks
Time frame: Baseline (T1), 2 weeks after (T2)
Changes from Baseline on Perceived Stress Scale
Time frame: Baseline (T1), 2 weeks after (T2)
Changes from Baseline on Loss of Control eating brief (LOCES-B) Scale
Time frame: Baseline (T1), 2 weeks after (T2)
Change from baseline on Eating Disorder Examination Questionnaire
Time frame: Baseline (T1), 2 weeks after (T2)
Change from baseline on Brief Resilience Scale (BRS)
Time frame: Baseline (T1), 2 weeks after (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline survey, Heart rate variability biofeedback and Educational materials in people with Eating Disorders and Eating, Binge, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline Heart Rate Variability (HRV and coherence scores) at 2 weeks (time frame: Baseline (T1), 2 weeks after (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.