An interventional study of Baseline Survey and Heart rate variability biofeedback in Migraine, Heart Rate Variability (HRV) and Autonomic Nervous System, sponsored by Arizona State University. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Arizona State University · Not applicable, Interventional, and Supportive care
Migraine is one of the most common neurological disorders, characterized by recurrent headaches, sensitivity to light and movement, nausea, and autonomic dysregulation. Although mind-body interventions like biofeedback have shown their efficacy, they remain underutilized due to barriers such as transportation, time constraints, lack of awareness, stigma, and cost. A targeted approach to enhancing HRV is HRV biofeedback (HRVB), a technique using visual or auditory feedback to help people regulate HRV through slow-paced breathing and positive emotional regulation to promote ANS balance and emotional resilience. Investigators will conduct a remotely delivered pilot RCT of an 8-week, 10 min/day, novel app-based HRVB intervention compared to a sham control intervention (matching intervention time and attention with no biofeedback component) in adult with chronic migraine. Investigators hypothesize data collected from the study will: a) support the feasibility and acceptability of the remotely delivered app-based HRVB intervention among adults with chronic migraine, and b) provide insights into refining the intervention by examining patterns of change in migraine and psychological outcomes from pre- to post-intervention.
This study is a randomized controlled trial aimed at examining the effect of Heart Rate Variability Biofeedback (HRVB) among people with chronic migraine. The primary objective of the study is to determine whether HRVB can positively impact the psychosocial health and well-being of those living with chronic migraines. Building upon our prior pilot RCT (IRB study ID: STUDY00018977; ClinicalTrials.gov ID: NCT06546163), which demonstrated the feasibility and acceptability of HRVB in college-aged women with disordered eating, investigators propose to examine the feasibility of a HRVB intervention using the device investigators have successfully implemented remotely, incorporating video guides and Zoom-based coaching for smartphone app set-up and use. Investigators will conduct a remotely delivered pilot RCT of an 8-week, 10 min/day, novel app-based HRVB intervention compared to a sham control intervention (matching intervention time and attention with no biofeedback component) in adult with chronic migraines. There will be 30 participants who experience chronic migraines that 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). Participants will first attend a baseline orientation meeting during which they complete baseline measures and will be asked to complete 28 days of a 5-10 minute daily diary survey about their migraine-related experiences. After the 28 days, participants will attend a zoom training meeting during which they complete a 5-minute heart rate measurement using a small earlobe sensor device that investigators will mail to participants , will be randomly assigned to the HRVB group or sham control group, and be asked to complete the daily diary assessments for another 28 days. After 8 weeks since the baseline and 4 weeks since group assignment, participants will attend a final zoom meeting to complete follow-up measures and the heart rate measurement. Investigators hypothesize data collected from the study will: a) support the feasibility and acceptability of the remotely delivered app-based HRVB intervention among adults with chronic migraines, and b) provide insights into refining the intervention by examining patterns of change in migraine and psychological outcomes from pre- to post-intervention.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Arizona State University is the lead sponsor of 238 studies on the registry; 42 are open to participants now.
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Participants will complete an online baseline survey and 28 days of baseline daily headache diary assessments prior to random assignment to the HRVB arm. This group will receive a standardized HeartMath© Inner Balance device by mail. Participants will attend a 30-40-minute one-on-one HRVB training session via Zoom prior to initiating the HRVB intervention and will be asked to practice HRV biofeedback at home for 10 minutes per day over an eight-week period. Participants will receive an email or phone notification as a weekly reminder to complete their at-home HRVB practice. At the end of the 8-week intervention period, participants will be scheduled for a follow-up Zoom meeting to collect a 5-minute post-intervention resting HRV measurement and will complete the T2 online survey.
Behavioral: Baseline Survey · Behavioral: Heart rate variability biofeedback
Participants will complete an online baseline survey and 28 days of baseline daily headache diary assessments prior to randomization to the sham control arm. Participants will receive a standardized HeartMath© Inner Balance device by mail and will attend a 30-40-minute one-on-one sham training session via Zoom before initiating the sham intervention. They will be instructed to engage in normal breathing at home for 10 minutes per day over an eight-week period, without receiving HRV biofeedback or real-time visualization. Weekly email or phone reminders will be provided to support adherence. At the end of the 8-week intervention period, participants will attend a follow-up Zoom visit to complete a 5-minute post-intervention resting HRV measurement and the T2 online survey.
Behavioral: Baseline Survey · Behavioral: Sham Control Group
Baseline surveys contain a series of scaled questions, including sociodemographic variables (age, sex, etc), information about migraine frequency and intensity, Insomnia Severity Index (ISI), Grade Chronic Pain Scale Revised (GCPS-R), Pain Catastrophizing Scale (PCS), Emotional Regulation Questionnaire (ERQ), Depression Anxiety Stress Scale-21 (DASS-21), and treatment expectations.
Participants randomized to the intervention arm will receive a standardized HRV sensor and accompanying smartphone application, along with a 30-40-minute HRVB training session focused on using biofeedback signals to generate a resonant frequency pattern of HRV (coherence) following baseline data collection. Participants will be asked to practice their HRVB skills at home for 10 minutes per day over a 8-week period.
Participants randomized to the sham control arm will receive a standardized HRV sensor and accompanying smartphone application, along with a 30-40-minute sham breathing training session following baseline data collection. Participants will be asked to practice their sham breathing exercises at home for 10 minutes per day over an 8-week period.
Recruitment, retention, and adherence rates (Feasibility)
Feasibility will be assessed using recruitment, retention, and intervention adherence, with benchmarks specified a priori. Recruitment is defined as the proportion of eligible individuals who enrolled in the study and was considered feasible if at least 60% enrolled. Retention is defined as the proportion of randomized participants who completed the post-intervention assessment at the end of the 12-week study and is considered feasible if at least 70% were retained. Intervention adherence is considered feasible if participants completed at least 70% of the prescribed intervention practice.
Time frame: From enrollment through completion of the 12-week study.
Changes from Baseline Migraine Frequency at 28 days
Migraine frequency will be assessed by the change from baseline in monthly (28-day) migraine days or moderate/severe headache days, assessed by the end of day headache daily diary .
Time frame: One month after baseline (T2), 8 weeks after baseline (4 weeks after T2) (T3)
Changes from Baseline Migraine Intensity at 28 days
Migraine intensity will be assessed using an 11-point rating scale.
Time frame: One month after baseline (T2), 8 weeks after baseline (4 weeks after T2) (T3)
Qualitative Acceptability Feedback (Acceptability)
Qualitative acceptability will be assessed using open-ended questions examining perceived benefits, challenges, and recommendations for improvement of the HRVB intervention. Metric: Thematic saturation and frequency of key themes Unit of Measure: Narrative themes categorized as benefits, barriers, and recommendations Benchmark: Identification of actionable themes supporting feasibility and refinement of implementation.
Time frame: At the post-intervention
Pain Catastrophizing Scale
An individual's pain experience will be measured using the Pain Catastrophizing Scale (PCS) (13 items, 5-point Likert scale; 0=not at all, 4= all the time ). The PCS has three subscales: rumination, magnification, and helplessness. The PCS has been used and validated in studies of psychosocial interventions for migraine patients. Individual scores on the PCS can range from 0 to 52 with higher scores indicating a worse pain experience . (Cronbach's a = .87).
Time frame: Baseline (T1) and 8 weeks after baseline (T3)
Emotional Regulation Questionnaire
Emotional regulation strategies will be measured using the Pain Catastrophizing Scale (ERQ) (10 items, 7-point Likert scale; 1= strongly disagree, 7= strongly agree). The ERQ has two subscales: cognitive reappraisal and expressive suppression. The ERQ has been used and validated in studies of psychosocial interventions for migraine patients. Individual scores on the PCS can range from 10 to 70 with higher scores indicating a greater frequency of use of emotional regulation strategies (Cronbach's a = 0.76-0.83).
Time frame: Basline (T1) and 8 weeks after baseline (T3)
Changes from 1-month after baseline (T2) Heart Rate Variability measurement at T3
The InnerBalance from HeartMath will be used to collect HRV data using a 5-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 10-minute paced breathing period per day to understand the effects of paced breathing on migraine during the intervention period. 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.
Time frame: One month after baseline (T2), 8 weeks after baseline (4 weeks after T2) (T3)
Depression Anxiety Stress Scale - Short Form (DASS-21)
General psychological distress will be measured using the Depression Anxiety Stress Scale (DASS-21) (21 items, 4-point Likert scale; 0= Did not apply to me at all, 3= Applied to me very much). The ERQ has three subscales: depression, anxiety, and stress. The ERQ has been used and validated in studies of psychosocial interventions for migraine patients. Individual scores on the DASS-21 can range from 0 to 63 with higher scores indicating greater levels of general psychological distress (Cronbach's a = 0.74).
Time frame: Baseline (T1) and 8 weeks after baseline (T3)
Insomnia Severity Index (ISI)
Severity of insomnia will be measured using the Insomnia Severity Index (ISI) (7 items, 5-point Likert scale; 0=None, 4=Very severe). The ISI has been used and validated in studies of psychosocial interventions for migraine patients. Individual scores on the DASS-21 can range from 0 to 28 with higher scores indicating more sever insomnia (Cronbach's a = 0.74).
Time frame: Baseline (T1) and 8 weeks after baseline (T3)
Graded Chronic Pain Scale-Revised (GCPS-R)
Chronic pain severity will be measured using the Graded Chronic Pain Scale-Revised (GCPS-R) (5 items, 5-point Likert scale; 0 = Not at all, 4 = Extremely). The GCPS-R is one of the most frequently used and validated scales in studies of psychosocial interventions for migraine patients.The scores on the GCPS-R can can be classfied form Grade 0 (no chronic pain) to Grade 3 (high impact chronic pain) (Cronbach's a = 0.87-0.94).
Time frame: Baseline (T1) and 8 weeks after baseline (T3)
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