Arizona State University
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…
Inclusion Criteria: 1. Individuals aged 18 years or older 2. Chronic migraine as determined by the Identify Chronic Migraine (ID-CM) assessment 3. Access to a smartphone and Wi-Fi 4. Fluent in English. Exclusion Criteria: 1. Major medical (e.g., cancer, HIV/AIDS) or psychiatric illness (e.g., schizophrenia) 2. Conditions that would potentially interfere with accurate detection of HRV data (i.e., medications that alter heart rhythms, indications of cardiac conduction abnormalities \[e.g., heart arrhythmias\], having a pacemaker or heart transplant) 3. Any form of mind-body intervention (3 or…
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.