Hybrid cognitive-behavioral therapy intervention for adolescents with co-occurring migraine and insomnia: a single-arm pilot trial

Objective: This study aimed to evaluate feasibility and acceptability of a hybrid cognitive-behavioral therapy intervention for adolescents with co-occurring migraine and insomnia. Background: Many youth with chronic migraine have co-occurring insomnia. Little research has been conducted to evaluate behavioral treatments for insomnia in youth with migraine. Design and Methods: We conducted a single-arm pilot trial to evaluate the feasibility and acceptability of delivering cognitive-behavioral therapy for insomnia to 21 youth (mean age 15.5, standard deviation 1.6) with co-occurring chronic migraine and insomnia. Adolescents completed up to 6 individual treatment sessions over 6 to 12 weeks, and 1 booster session 1 month later. Assessments included a prospective 7-day headache and sleep diary, and self-report measures of insomnia, sleep quality, sleep habits, and activity limitations at pre-treatment, immediate post-treatment, and 3-month follow-up. Results: Adolescents demonstrated good treatment adherence and families rated the intervention as highly acceptable. Preliminary analyses indicated improvements from pre-treatment to post-treatment in primary outcomes of headache days (M = 4.7, SD = 2.1 vs M = 2.8, SD = 2.7) and insomnia symptoms (M = 16.9, SD = 5.2 vs M = 9.5, SD = 6.2), which were maintained at 3-month follow-up (M = 2.7, SD = 2.8; M = 9.3, SD = 5.0, respectively). We also found improvements in secondary outcomes of pain-related activity limitations as well as sleep quality, sleep hygiene, and sleep patterns. Conclusions: These preliminary data indicate that hybrid cognitive-behavioral therapy is feasible and acceptable for youth with co-occurring chronic migraine and insomnia. Future randomized controlled trials are needed to test treatment efficacy on migraine, sleep, and functional outcomes. ClinicalTrials.gov Identifier: NCT03137147.