Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial (I-SPY-RCT)

Insomnia is a common comorbidity among adolescents with migraine. This randomized controlled clinical trial aims to determine efficacy of cognitive-behavioral therapy (CBT) for insomnia, as well as the combined effect of CBT insomnia and pain interventions, on reducing insomnia symptoms and headache-related disability in adolescents with migraine. The long-term goal is to offer effective, tailored self-management interventions that can address migraine and co-morbid sleep problems in adolescence and disrupt a cycle of persistent, disabling migraine from continuing into adulthood.

This aims of this study are to: 1) test efficacy of cognitive-behavioral therapy (CBT) insomnia intervention for youth with migraine and comorbid insomnia, and 2) investigate how changes in sleep may modify response to CBT pain intervention. Participants will include 250 youth and their parents. Youth will be ages 11-17 years, with migraine (with or without aura, chronic migraine) and comorbid insomnia. In Phase 1, participants will be randomly assigned to receive access to internet-delivered CBT insomnia intervention or internet-delivered sleep education control over 6 weeks. In Phase 2, all participants will receive access to internet-delivered CBT pain intervention over 6 weeks. Assessments will occur at baseline, immediately after Phase 1 intervention, immediately after Phase 2 intervention, and 6 month follow-up.

The study design is a two arm, two-phase RCT. In Phase 1, the effects of internet-delivered CBT insomnia intervention will be compared to internet-delivered sleep education control. In Phase 2, all participants will receive internet-delivered CBT pain intervention.

Because all study procedures delivered online, neither study participants nor investigators. care providers, or outcomes assessors will have knowledge of the treatment assignment and thus this trial can be carried out as a double-blinded RCT.

Participants will receive access to internet-delivered sleep education during Phase 1 (6 weeks) of the study followed by internet-delivered CBT for pain management during Phase 2 (6 weeks) of the study.

Participants will receive access to internet-delivered CBT for insomnia during Phase 1 (6 weeks) of the study followed by internet-delivered CBT for pain management during Phase 2 (6 weeks) of the study.

The program delivers the core components of CBT for insomnia including sleep hygiene, stimulus control, and sleep restriction. Treatment duration is 6 weeks.

The program delivers the core components of CBT for pain management including: pain education, training in behavioral and cognitive pain coping skills, instruction in increasing activity participation, and training in parental operant and communication strategies. Treatment duration is 6 weeks.

The 7-item Insomnia Severity Index (ISI) measures severity of insomnia symptoms. Total scores above 8 on the ISI indicate clinically significant insomnia in adult and adolescent samples.

Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

The CALI-9 is a 9-item self-report instrument of headache-related disability in children and adolescents that measures difficulty in performing usual daily physical, social, and recreational activities. The measure will be completed daily for 14 days at baseline, after phase 1, after phase 2, and 6-month follow-up

Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

The Adolescent Sleep Wake Scale-Short Form (ASWS) is a 10-item measure. The total score indicates overall perception of sleep quality.

Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

14-days of actigraphic monitoring with the Actiwatch Spectrum Plus to assess minutes of estimated sleep, wake time after sleep onset, and sleep efficiency.

Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

11-point numerical rating scale with anchors of 0 = no pain to 10 = worst pain possible. Reported each day for 14 days.

Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

The Generalized Anxiety Disorder-7 is a 7-item measure. The total score indicates anxiety severity over the last two weeks.

Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

The Patient Health Questionnaire-9 is a 9 item measure. The total score indicates severity of depression over the last two weeks.

Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

The Pediatric Quality of Life Inventory 4.0. is a measure of health-related quality of life. The total score indicates perceived mental and physical health.

Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

Inclusion Criteria: 11-17 years old Headache present for at least three months and insomnia symptoms for the past month Access to the Internet on any web-enabled device Exclusion Criteria: Non-English speaking Diagnosed sleep disorder (e.g. sleep apnea, narcolepsy) Unable to read at 5th grade level or complete surveys independently A serious comorbid chronic condition (e.g., diabetes, arthritis, cancer)