Self‐administered biofeedback treatment app for pediatric migraine: A randomized pilot study

Abstract

Objective To investigate the effect size, safety, and tolerability of a therapist‐independent biofeedback treatment app among adolescent with migraine. Materials and Methods This was a prospective, 3:1 ratio randomized, sham‐controlled, double‐blind, pilot study with 16 adolescents diagnosed with migraine randomized to eight weeks of biofeedback treatment (n = 12) or sham biofeedback (n = 4), carried out at two university hospitals in Norway. The prespecified and primary objective of the study was to observe changes in outcomes within the active treatment group. The sham control group was included in a minor ratio primarily to evaluate its feasibility. The primary outcome was change in headache frequency. A modified intention to treat analysis was performed, including participants completing at least seven biofeedback sessions in weeks 1–4 (n = 12 vs. n = 4) and weeks 5–8 (n = 7 vs. n = 2). Results Adherence was poor with 40% (136/336) of planned biofeedback sessions completed during weeks 5–8. Within the biofeedback group, a not statistically significant reduction in headache frequency was observed at weeks 1–4 (2.92 days/month, 95% CI −1.00 to 6.84, p = .145) and weeks 5–8 (1.85 days/month, 95% CI −2.01 to 5.72, p = .395). The biofeedback group experienced a median of one fewer headache days/month versus sham that did not reach significance (95% CI −4.0 to 9.0, p = .760). Conclusions We observed a small reduction in headache frequency in the active treatment group. Findings were likely undermined by low adherence and underpowered analyses but indicate that a therapist‐independent biofeedback treatment app has the potential to be an effective, tolerable, and inexpensive treatment option.

Digital headache self‐management interventions for patients with a primary headache disorder: A systematic review of randomized controlled trials

“…Headache disability was assessed in 9 of the 13 studies (69%) 34,37,39,41,44–48 . Specifically, Devineni and Blanchard used an interactive website with therapist support and demonstrated a significant decline in headache disability in the treatment arm compared to the control arm at post‐intervention 39 .…”

“…Seven studies (n = 7/13; 54%) did not report racial/ethnic composition of the sample. [37][38][39][40][41][42][43] Across studies that reported the racial/ethnic composition of the sample (n = 6), 34,[44][45][46][47] White/Caucasian participants comprised 45-94% of the study samples with two thirds of these studies (n = 4) including a sample that was >75% White/Caucasian. 34,44,45,47 Diagnosis of a primary headache disorder was an inclusion criteria for all studies with 69% (9/13) of these studies focusing exclusively on patients with migraine.…”

“…46,48 Two interventions used an mHealth app as a platform to provide biofeedback 41,47 with one of these apps also including a headache diary. 41 One intervention used an interactive website with modules on migraine-specific psychoeducation, self-management (e.g., selfmonitoring, relaxation training), coping (e.g., managing migrainerelated anxiety and negative thinking), communication skills (e.g., effective patient-provider communication), and medication safety. 44 One intervention that was tested in two separate study samples used an interactive CD-ROM intervention that included modules on headache psychoeducation, relaxation training, cognitive coping skills, and problem solving.…”

“…34,37,38,[41][42][43]45,46,49 Specifically, Connelly et al used an interactive CD-ROM intervention and demonstrated a significant decline in headache frequency in the treatment arm compared to the control arm at post-intervention. 45 Seven studies demonstrated no significant between-group changes in headache frequency, 34,37,38,[41][42][43]46,49 with one study also showing no change at 3-month follow-up. 34 Five studies examined within-group differences in headache frequency.…”

The Role of the Autonomic Nervous System in Headache: Biomarkers and Treatment

“…A number of studies utilizing mindfulness interventions have been reported. In a recent review, Stubberud et al [ 69 ] concluded that “…mindfulness may be an important tool as part of a comprehensive treatment approach to help patients ‘mindfully’ engage in valued life activities.” (p. 217).…”