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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Migraine Disorders; Insomnia; Headache Disorders
• Intervention / Treatment: Behavioral: Internet-delivered CBT for Pain Management; Behavioral: Internet-delivered Sleep Education; Behavioral: Internet-delivered CBT for Insomnia

Detailed Description

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
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tonya Palermo, PhD; Phone Number: 206-884-4208; Email: tonya.palermo@seattlechildrens.org
• Study Contact Backup: Name: Emily Law, PhD; Phone Number: 206-884-1197; Email: emily.law@seattlechildrens.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: University of Virginia
• Investigators: Principal Investigator: Emily Law, PhD, Seattle Children's Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: pain; sleep; pediatric; adolescent; children; headache; cognitive-behavioral therapy
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pain; Neurologic Manifestations; Headache Disorders, Primary; Sleep Initiation and Maintenance Disorders; Migraine Disorders; Headache; Headache Disorders
• Other Study ID Numbers: STUDY00003090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No