App-based Breathing Program for Migraine Relief

Arizona State University (ASU)

Status: Invitation-only

Conditions: Headache (Migraine); Breathing; Chronic Pain; Migraine; Autonomic Nervous System; mHealth; Heart Rate Variability (HRV); Headache

Treatments: Behavioral: Heart rate variability biofeedback; Behavioral: Sham Control Group; Behavioral: Baseline Survey

Study type: Interventional

Funder types: Other

Identifiers

NCT07297901

STUDY00023014

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 more times per week) during the past 3 months.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

30 participants in 2 patient groups

Baseline and HRVB

Experimental group

Description:

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.

Treatment:

Behavioral: Baseline Survey

Behavioral: Heart rate variability biofeedback

Baseline and Sham Control Group

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Baseline Survey

Behavioral: Sham Control Group