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

Insomnia Clinical Trial

— I-SPY-RCT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04936321
• Other study ID #: STUDY00003090
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 224
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Headache
• Headache Disorders
• Insomnia
• Migraine Disorders
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.
• Internet-delivered Sleep Education
The program delivers publicly available information about sleep.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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