App-based Breathing Program for Migraine Relief

Official title

Headache Calm: App-based Breathing Program for Migraine Relief

Overview

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.

Detailed 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.

Interventions

• Behavioral Baseline Survey
  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.
• Behavioral Heart rate variability biofeedback
  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.
• Behavioral Sham Control Group
  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.

Primary outcome measures

• Changes from Baseline Migraine Frequency at 28 days [Time frame: One month after baseline (T2), 8 weeks after baseline (4 weeks after T2) (T3)]

Secondary outcome measures (6)

• Pain Catastrophizing Scale [Time frame: Baseline (T1) and 8 weeks after baseline (T3)]
• Emotional Regulation Questionnaire [Time frame: Basline (T1) and 8 weeks after baseline (T3)]
• Changes from 1-month after baseline (T2) Heart Rate Variability measurement at T3 [Time frame: One month after baseline (T2), 8 weeks after baseline (4 weeks after T2) (T3)]
• Depression Anxiety Stress Scale - Short Form (DASS-21) [Time frame: Baseline (T1) and 8 weeks after baseline (T3)]
• Insomnia Severity Index (ISI) [Time frame: Baseline (T1) and 8 weeks after baseline (T3)]
• Graded Chronic Pain Scale-Revised (GCPS-R) [Time frame: Baseline (T1) and 8 weeks after baseline (T3)]

Eligibility criteria

Inclusion criteria

• Individuals aged 18 years or older
• Chronic migraine as determined by the Identify Chronic Migraine (ID-CM) assessment
• Access to a smartphone and Wi-Fi
• Fluent in English.

Exclusion criteria

• Major medical (e.g., cancer, HIV/AIDS) or psychiatric illness (e.g., schizophrenia)
• 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)
• Any form of mind-body intervention (3 or more times per week) during the past 3 months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• Arizona State University — Phoenix

Identifiers

NCT: NCT07297901 · STUDY00023014

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗