Intervention for Sleep and Pain in Youth: a Randomized Controlled Trial
- Conditions
- Headache DisordersInsomniaMigraine Disorders
- Interventions
- Behavioral: Internet-delivered CBT for Pain ManagementBehavioral: Internet-delivered CBT for InsomniaBehavioral: Internet-delivered Sleep Education
- Registration Number
- NCT04936321
- Lead Sponsor
- Seattle Children's Hospital
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 224
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sleep Education + CBT for Pain Internet-delivered CBT for Pain Management 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. Sleep Education + CBT for Pain Internet-delivered Sleep Education 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. CBT for Insomnia + CBT for Pain Internet-delivered CBT for Insomnia 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. CBT for Insomnia + CBT for Pain Internet-delivered CBT for Pain Management 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.
- Primary Outcome Measures
Name Time Method Change in insomnia symptoms 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 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 Outcome Measures
Name Time Method Change in sleep quality 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 anxiety symptoms 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 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 sleep patterns 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 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 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 health-related quality of life as assessed by the Pediatric Quality of Life Inventory 4.0 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.
Trial Locations
- Locations (1)
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States