Completed

NCT Number: NCT04936321

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

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.

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Key information

Conditions

Insomnia Brain Diseases Central Nervous System Diseases Dyssomnias Headache Headache Disorders Headache Disorders, Primary Mental Disorders Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Internet-delivered CBT for Insomnia

Behavioral

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 Management

Behavioral

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.

Other names: Web-MAP (Web-based Management of Adolescent Pain)

Internet-delivered Sleep Education

Behavioral

The program delivers publicly available information about sleep.

Primary outcomes

Change in insomnia symptoms

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

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.
Change in headache-related disability

Time frame: 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

Secondary outcomes

Change in sleep quality

Time frame: 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.
Change in sleep patterns

Time frame: 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.
Change in headache frequency

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

The number of headache days reported each day for 14 days.
Change in headache pain intensity

Time frame: 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.
Change in anxiety symptoms

Time frame: 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.
Change in depressive symptoms

Time frame: 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.
Change in health-related quality of life as assessed by the Pediatric Quality of Life Inventory 4.0

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

University of Virginia

Registry information

Official study title

Enhancing the Efficacy of Migraine Self-Management in Children With Comorbid Insomnia

Acronym: I-SPY-RCT

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Jun 23, 2021
Registry last updated: Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed