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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Insomnia, Migraine Disorders, Headache Disorders

Intervention / Treatment
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* Behavioral: Internet-delivered CBT for Insomnia
* Behavioral: Internet-delivered CBT for Pain Management
* Behavioral: Internet-delivered Sleep Education


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sleep Education + CBT for Pain<br>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. | Behavioral: Internet-delivered CBT for Pain Management<br>* 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.<br>* Other names: Web-MAP (Web-based Management of Adolescent Pain);Behavioral: Internet-delivered Sleep Education<br>* The program delivers publicly available information about sleep.<br>|
| Experimental: CBT for Insomnia + CBT for Pain<br>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. | Behavioral: Internet-delivered CBT for Insomnia<br>* The program delivers the core components of CBT for insomnia including sleep hygiene, stimulus control, and sleep restriction. Treatment duration is 6 weeks.<br>Behavioral: Internet-delivered CBT for Pain Management<br>* 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.<br>* Other names: Web-MAP (Web-based Management of Adolescent Pain);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up | 
| Change in headache-related disability | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep quality | 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 | 
| Change in sleep patterns | 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 | 
| Change in headache frequency | The number of headache days reported each day for 14 days. | Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up | 
| Change in headache pain intensity | 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 | 
| Change in anxiety symptoms | 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 | 
| Change in depressive symptoms | 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 | 
| Change in health-related quality of life as assessed by the Pediatric Quality of Life Inventory 4.0 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, children, adolescent, sleep, pain, headache, cognitive-behavioral therapy