Focus group findings on the migraine patient experience during research studies and ideas for future investigations.

OBJECTIVES: We conducted focus groups in people who had participated in mobile health (mHealth) studies of behavioral interventions for migraine to better understand: (a) Participant experience in the recruitment/enrollment process; (b) participant experience during the studies themselves; (c) ideas for improving participant experience for future studies. METHODS: We conducted four focus groups in people who had agreed to participate in one of three studies involving mHealth and behavioral therapy for migraine. Inclusion criteria were being age 18-80, owning a smartphone, and having four or more headache days per month. All participants met the International Classification of Headache Disorders third edition beta version criteria for migraine. Exclusion criteria were not speaking English and having had behavioral therapy for migraine in the past year. Focus groups were audio recorded, fully transcribed and coded using general thematic analysis. RESULTS: The 12 focus group participants had a mean age of 45 ± 15, a mean age of headache onset of 21 ± 13 and mean MIDAS disability score was 39 ± 56. Participants were women (100%), white (50%), Asian (33.3%) or members of other racial groups (16.7%). Certain themes emerged from each topic area. With regard to recruitment/enrollment (a), key themes were: (i) Participants joined their study out of an interest in research and/or a desire to try a new migraine treatment modality (behavioral therapy). (ii) Enrollment should be simple and study requirements should be carefully explained prior to enrollment. When asked about their experiences during the studies (b), the following themes emerged: (i) It is difficult to participate in study follow-up and compliance phone calls; (ii) participants prefer to choose from among various options for contact with the study team; (iii) there are barriers that limit app use related to migraine itself, as well as other barriers; (iv) completing diaries on a daily basis is challenging; (v) technical difficulties and uncertainties about app features limit use; (vi) being part of a research study promoted daily behavioral therapy use; (vii) progressive muscle relaxation (PMR) is enjoyable, and has a positive impact on life; (viii) behavioral therapy was a preferred treatment to reduce migraine pain. Ideas for improving study design or patient experience (c) included: (i) Increased opportunity to interact with other people with migraine would be beneficial; (ii) navigating the app and data entry should be easier; (iii) more varied methods for viewing the data and measures of adherence are needed; (iv) more information on and more varied behavioral treatment modalities would be preferred. CONCLUSION: Though people with migraine are motivated to participate in mHealth and behavioral treatment studies, better communication up front about interventions as well as greater flexibility in interventions and follow-up methods are desired.

Smartphone based behavioral therapy for pain in multiple sclerosis (MS) patients: A feasibility acceptability randomized controlled study for the treatment of comorbid migraine and ms pain.

BACKGROUND: Multiple Sclerosis (MS) and Migraine are comorbid neurologic conditions. Migraine prevalence is three times higher in the MS clinic population compared to the general population, and patients with MS and migraine are more symptomatic than patients with MS without migraine. OBJECTIVE: We sought to conduct a pilot feasibility and acceptability study of the RELAXaHEAD app in MS-Migraine patients and to assess whether there was any change in migraine disability and MS pain-related disability. METHODS: Randomized controlled study of patients with MS-migraine ages 18-80 years with 4+ headache days/ month who were willing to engage in smartphone based behavioral therapy. Half received the RELAXaHEAD app with progressive muscle relaxation (PMR) and the other half received the app without the PMR. Data was collected for 90 days on measures of recruitment, retention, engagement, and adherence to RELAXaHEAD. Preliminary data was also collected on migraine disability (MIDAS) and MS pain (PES). RESULTS: Sixty-two subjects with MS-migraine were enrolled in the study (34 in PMR arm, 28 in monitored usual care arm). On average, during the 90 days, participants played the PMR on average 1.8 times per week, and for 12.9 min on days it was played. Forty-one percent (14/34) of the participants played the PMR two or more times weekly on average. Data was entered into the daily diaries, on average, 49% (44/90) of the days. There were major challenges in reaching subjects in follow-up for the efficacy data, and there was no significant change in migraine disability (MIDAS) scores or MS Pain (PES) scores from baseline to the endpoints. During the six-month follow-up, most patients felt either positively or neutral about the relaxation therapy. CONCLUSION: There was interest in scalable accessible forms of behavioral therapy to treat migraine and MS-related pain in patients with MS and comorbid migraine. Similar to prior studies, a significant minority were willing to practice the PMR at least twice weekly. In the societal shift from telephone to more text and internet-based interactions, follow up was challenging, but those reached indicated that they appreciated the PMR and would recommend it to others. Future work should focus on engagement and efficacy.