Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial

Seattle Children's Hospital224 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

224

Conditions

Insomnia

Interventions

Internet-delivered CBT for InsomniaBEHAVIORAL

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

Internet-delivered CBT for Pain ManagementBEHAVIORAL

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.

Internet-delivered Sleep EducationBEHAVIORAL

The program delivers publicly available information about sleep.

Eligibility

Sex: ALLMin age: 11 YearsMax age: 17 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Change in insomnia symptoms

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.