A smartphone application (app) providing a progressive muscle relaxation (PMR) intervention was adopted by approximately half of patients with migraine introduced to this option, and its use was associated with fewer headache days, lower depression scores, and higher anxiety scores, according to a pilot study published in Nature Digital Medicine.
Nonpharmacologic approaches to migraine prophylaxis (eg, cognitive behavioral therapy [CBT], relaxation) have shown to be efficacious in the long term, to be devoid of adverse events, and less costly compared with pharmacologic treatments. Due to limited healthcare practitioner training and low reimbursement rates by insurances, approximately half of the patients seeking behavioral therapy from a specialist were found to initiate treatment, and for those who did, adherence was not optimal.
In an effort to palliate these hurdles, researchers from several institutions in New York sought to examine the efficacy of a smartphone app delivering PMR, a mind-body intervention shown to effectively prevent migraine. With this study, investigators sought to examine the feasibility, acceptability, and efficacy of the RELAXaHEAD app delivering PMR for the self-management of migraine, as well as predictors of app use.
The study’s primary outcomes included the number of days the headache diary and PMR were used during the study period (90 days), and the daily length of PMR use. Secondary outcomes were the number of headache days (in high- and low-app users), as well as predictors of app and PMR use. Predictors of use examined included demographic indicators (eg, gender, age, and race), headache parameters (eg, monthly number of headache days), and mental health indicators (ie, depression and anxiety). Participants’ data were collected at baseline, during follow-up calls at 1, 2, and 3 months, and from the app.
A total of 51 patients (94% women; mean age, 39±13; 75% white) were recruited from the New York University Langone Health Neurology practice between 2017 and 2018. To be included, patients had to be aged 18 to 80, speak English, own a smartphone, have a neurologist-confirmed migraine diagnosis, and experience ≥4 headache days per month.
The participants’ variables at baseline were the following: 63% with severe migraine-related disability; mean monthly headache days, 13±8 (range, 4-31); 100% with prior use of abortive medications; 75% with prior use of migraine prophylactic medications; 18% with prior use of opioid medications for migraine treatment; 29% with prior use of behavioral therapy >1 year before study (CBT, 11; biofeedback, 6; PMR, 2); 39% with a comorbid pain condition (eg, fibromyalgia, chronic back pain); 39% with anxiety; 33% with depression; and mean depression and anxiety scores on the Patient-Reported Outcomes Measurement Information System scale (PROMIS), 50±10 (range, 31-72) and 50±10 (range, 31-75), respectively.
Study participants were asked to complete a satisfaction survey after their initial PMR session using a 1 to 5 Likert scale, on which they indicated (strongly) agreeing (ie, mean Likert scores of 4-5) about the easiness and relevance of the app for headache and about the likelihood of using the app in the future. They also expressed neutrality regarding the didactic potential of the app and its possible effects on stress and mood.
Participants reported using a headache diary on 46±33 days on average (range, 1-90 days), with 63% of headache-free days, and 63% and 58% of diary uses for ≥1 and ≥2 times per week, respectively. The PMR component was played an average of 22±21 times (range, 1-76; mean duration per session, 11±7 min), with 47% of total uses per week. The headache diary was used during the first week of the study by all participants, a participation which dropped to 63% and 49% during weeks 6 and 12, respectively. The PMR app was used by 84%, 51%, and 29% of participants during weeks 1, 6, and 12, respectively, with a majority using the technology in the first 6 weeks.
Reasons for not using the app ranged from a dislike of the audio file or PMR behavior, to technical issues, and difficulty continuing the practice, according to responses on follow-up calls. High- and low-app users reported a reduction in headache days in month 2 vs month 1 (reduction: 4 and 2 days, respectively; P =.02), with a mean reduction in headache days between these 2 months of 2 for high users, and an increase of 3 headache days in low users (high vs low users, P =.002).
The PROMIS depression and anxiety scores were found to be negatively and positively associated with the odds of using ≥1 time vs not using the app over the course of a week, respectively (odds ratio [OR], 0.70; 95% CI, 055-0.85 and OR, 1.33; 95% CI, 1.09-1.73, respectively). Use of the PMR intervention at least once weekly vs none was negatively associated with the PROMIS depression score (OR, 0.77; 95% CI, 0.68-0.91), and keeping an interest in the app was positively associated with the PROMIS anxiety score (OR, 5.4; 95% CI, 1.22-20.90). These models used to predict diary and PMR use were found to perform well, as indicated by the respective areas under the curve.
Study limitations include a small number of participants and the lack of determination of intervention efficacy.
“We found that in a convenience sample of 51 patients with severe migraine disability, about 1 of every 2 patients demonstrated engagement with smartphone-based PMR intervention based upon a brief, initial introduction to the app. Also, there appeared to be time-limited acceptability of the intervention by 6 weeks. This is a promising area given its low cost, scalable method and future studies can begin to examine efficacy,” concluded the study authors.
Minen M, Adhikari S, Seng E, Berk T, Jinich S, Powers S, Lipton R. Smartphone-based migraine behavioral therapy: A single arm study with assessment of mental health predictors. npj Digital Medicine (2019) 2:46; https://doi.org/10.1038/s41746-019-0116-y