Single arm feasibility trial of a mobile application for adolescent migraine management

Dear Editor,

Introduction

Treatment for migraine in adolescents includes pharmacological therapy, adherence to healthy habits (eg, sufficient sleep, adequate hydration, healthy diet, and exercise), and biobehavioral interventions, such as relaxation, biofeedback, and progressive muscle relaxation.¹ While the efficacy of pharmacological treatments for migraine in children and adolescents have been inconclusive, biobehavioral interventions have shown significant reductions in migraine frequency and disability as well as improvement in health-related quality of life (HRQOL).² Unfortunately, significant barriers to biobehavioral interventions exist for patients, including access to treatment.

Increased mobile device use suggests that mobile health (mHealth) platforms provide an ideal delivery mechanism for biobehavioral interventions to address treatment access barriers. Further, recent studies have provided evidence for the use of smartphone apps targeting migraine self-management behaviors including adherence to healthy habits and medication.³ In this study, we evaluated Easeday, a mobile app using relaxation training tailored for migraine treatment that has been used for reducing headache frequency and disability in adults.⁴ We assessed feasibility, satisfaction, and preliminary clinical signals of the app in reducing headaches in a sample of adolescents with migraine using qualitative and quantitative data. Secondary outcomes included functional disability, HRQOL, and sleep parameters.

Methods

Participants

Participants (N = 18) were 13–17 years old with a confirmed migraine diagnosis using International Classification of Headache Disorders Criteria (ICHD-3) or confirmed diagnosis of continuous headache recruited from a tertiary headache clinic at a large children’s hospital.

Application

The Easeday app includes a daily agenda comprised of a relaxation and biofeedback activity and multiple modules focused on education, cognitive-behavioral pain management training, sleep, and migraine trigger identification that participants could use. For biofeedback, participants used the heart rate variability (HRV) feature, which involved placing one’s thumb on the mobile device’s flashlight to detect heart rate, for up to 20 minutes based on participant preference.

Procedures

Approval for study procedures was obtained by our Institutional Review Board. At baseline, participants completed 28-day headache and sleep diaries in REDCap followed by a 20–30 minute baseline assessment battery (see Table 1). During the 4-week intervention, participants completed the daily agenda in the app (ie, biofeedback and/or relaxation activity) and continued to complete headache and sleep diaries. Participants were encouraged to complete the sleep module within the first week of the intervention and use these skills when experiencing sleep difficulties, and to complete a relaxation or biofeedback activity at the first sign of a headache. At post-treatment, participants completed the same battery as the baseline assessment as well as a qualitative interview with study personnel.

Table 1.

Study assessments.

Assessment	Description
Demographics	Variables: Participant age, gender, race, ethnicity, year in school/employment status, migraine and/or headache diagnosis, date of diagnosis, and treatment regimen. Data verified via chart review.
Pain Catastrophizing Scale (PCS-C)5	13-item self-report measure. Each item is a 5-point scale. Assesses the extent to which adolescents experience catastrophic thoughts and feelings when in pain.
Functional Disability Inventory (FDI)6	15-item self-report measure. Each item is a 5-point scale. Assesses perceived difficulty in completion of daily activities across home, school, leisure, and social domains.
Pediatric Quality of Life Inventory (PedsQL)7	23-item self-report and parent/caregiver-report measure. Each item is a 5-point scale. Assesses HRQOL for children ages 2–18 across 4 areas of functioning: Physical, emotional, social, and school.
Screen for Child Anxiety Related Emotional Disorders (SCARED)8	41-item self-report measure. Each item is a 3-point scale. Assesses youth anxiety symptoms across 5 subscales: Panic/somatic symptoms, generalized anxiety, separation anxiety, social phobia, and school anxiety.
Adolescent Sleep Hygiene Scale (ASHS)9	28-item self-report measure. Each item is a 6-point scale. Assesses sleep facilitating and sleep-inhibiting behaviors in adolescents across 9 subscales: Physiological, cognitive, emotional, sleep environment, daytime sleep, substances, bedtime routine, sleep stability, and bed/bedroom sharing.
Sleep diary	9 prompts (eg, time into bed, time of sleep attempt, time it took to fall asleep) from the Consensus Sleep Diary assessment10 on a 5-point scale, which are used to assess participant sleep patterns.
Headache diary	Assessed presence of headache, time, duration, and location of the headache, associated symptoms (eg, nausea), pain type (eg, throbbing), intensity, medication taken, interference with activities, and perceived triggers to the headache.
Satisfaction	Participants provided qualitative responses to questions regarding app content, ability, and ease of incorporating app use into their daily routines, and the likelihood of recommending the app to peers with migraine and continuous headache.
Feasibility	Feasibility data were obtained via recruitment and retention as well as app usage analytics.

Data analysis

Feasibility was assessed via recruitment/retention data and app usage. User satisfaction was assessed via qualitative feedback. Responses were reviewed and themes were identified. Prior to examining the quantitative data, missing data analyses were conducted. Within-subject pairwise comparisons were conducted for general functional disability, HRQOL, pain catastrophizing, anxiety, sleep hygiene, and sleep diary outcomes.

Results

Participants

Participants (N = 18) were, on average, 15 years old, 78% female, 100% White, 100% Non-Hispanic, and 21 months from diagnosis in the medical chart. Diagnoses were chronic migraine (n = 14, 78%) migraine without aura (n = 3, 17%), hemiplegic migraine (n = 1, 6%), and chronic daily headache (n = 1, 6%).

Feasibility/user satisfaction data

Feasibility was demonstrated via several methods. We enrolled 83% of patients recruited, and 90% of those enrolled completed the app intervention and assessments. Only one participant was unable to engage with the app due to not having access to an iOS device. On average, participants used the app on 11.28 days, completed 29 of 50 modules, spent 1 hour 49 minutes in treatment modules (3 minutes 13 seconds/module), and completed 7.72 HRV sessions.

Participants gave positive reviews of some biobehavioral components of the app including relaxation training and breathing techniques as this helped them manage stress with their headaches. Education modules helped identify perceived migraine triggers as well. The HRV component, while novel, was difficult to use, which impacted the frequency of use. The length of the diary was also a barrier to daily completion. See Table 2.

Table 2.

User satisfaction and feedback data.

Positively Rated App Qualities	Negatively Rated App Qualities	Areas for Improvement
Participants reported the Easeday app was most beneficial for relaxation. It was helpful learning different breathing techniques, with the most preferred method being deep breathing. The relaxation techniques also helped them manage stress and their headaches. Participants liked that the daily agenda feature kept them on track with consistent app use and helped them identify perceived migraine triggers. HRV feature was “cool,” participants liked the visual, it helped them breathe deeper, and it was a quick way to manage a migraine.	App malfunction was a frequent complaint, such as the daily agenda not checking tasks off when they were completed. The aspect of the app that was identified as least helpful across participants was the HRV component, due to it being hard to use, not working, and being finicky. Participants noted that the app was neither helpful nor unhelpful in managing their migraines better.	Participants reported that they wanted the HRV component to be easier to use, less sensitive to movement, have photos/videos that provide instructions on how to set up the monitor, and have audio guidance during the breathing exercise. They wanted the app to be generally easier to use, have more options, have a shorter diary, and make it more kid/teen friendly.

Abbreviation: HRV = heart rate variability.

Preliminary clinical signals

Due to the small sample size and amount of missing data for the daily headache diary tracking number of headache days, missing data methods were not feasible and these data were not analyzed. For the daily sleep diary, an average of sleep latency, sleep time, and sleep awakenings was used based on the number of diary days completed, which allowed for analysis despite missing data. Participants demonstrated decreased anxiety (M_diff = −4.84, SE = 1.41, Hedges g = 0.81), pain catastrophizing (M_diff = −5.39, SE = 1.43, Hedges g = 0.89), and functional disability (M_diff = −2.99, SE = 1.12, Hedges g = 0.63). There were no changes in HRQOL, sleep hygiene, sleep latency, sleep time, and night-time awakenings from baseline to post-treatment. There was a modest change in the expected direction in the social functioning domain of quality of life (M_diff = 39.95, SE = 21.86, Hedges g = 0.43).

Discussion

In this feasibility trial, we found that participants were easily recruited and appropriately engaged with the Easeday app. They demonstrated improvements in anxiety, pain catastrophizing, and functional disability with medium-to-large effect sizes. Frequent and frustrating app malfunctions were reported; though, participants benefitted from the biobehavioral and education components for managing stress and identifying triggers.

Limitations include limited treatment duration and lack of diagnostic and racial/ethnic diversity in the sample. The overall feasibility of the app reported by participants as well as the preliminary quantitative data on outcomes suggest further inquiry is warranted. Future research should involve addressing usability issues, a longer treatment period to help establish practice patterns for biobehavioral pain management and daily task and diary completion, long-term follow-up to allow for evaluation of changes in all clinical outcomes of interest, and more diverse samples to ensure generalizability of findings.

In conclusion, this feasibility study demonstrated that adolescents are interested in using digital health solutions for headache management. The access benefits and potential impact on health outcomes that evidence-based digital treatment solutions offer warrant further investigation.

 

Clinical trials registry site and number: N/A.

Funding

National Institutes of Health/Eunice Kennedy Schriver National Institute of Child Health and Human Development T32 HD068223.

Conflicts of interest: None declared.