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dc.contributor.authorStubberud, Anker
dc.contributor.authorLinde, Mattias
dc.contributor.authorBrenner, Eiliv
dc.contributor.authorHeier, Martin
dc.contributor.authorOlsen, Alexander
dc.contributor.authorAamodt, Anne Hege
dc.contributor.authorGravdahl, Gøril Bruvik
dc.contributor.authorTronvik, Erling Andreas
dc.identifier.citationBrain and Behavior. 2021, 11 (2), 1-11.en_US
dc.description.abstractObjective 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.en_US
dc.publisherWiley Periodicals LLCen_US
dc.rightsNavngivelse 4.0 Internasjonal*
dc.titleSelf-administered biofeedback treatment app for pediatric migraine: A randomized pilot studyen_US
dc.typePeer revieweden_US
dc.typeJournal articleen_US
dc.source.journalBrain and Behavioren_US
dc.description.localcodeThis is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.en_US

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Navngivelse 4.0 Internasjonal
Except where otherwise noted, this item's license is described as Navngivelse 4.0 Internasjonal