Clinical trial NCT04936321: Intervention for Sleep and Pain in Youth: a Randomized Controlled Trial
Official title: Enhancing the Efficacy of Migraine Self-Management in Children with Comorbid Insomnia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Insomnia
Migraine Disorders
Headache Disorders
Keywords: pediatric
children
adolescent
sleep
pain
headache
cognitive-behavioral therapy
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Virginia
First posted: 2021-06-23
Enrollment: 224
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in insomnia symptoms
timeFrame: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
measure: Change in headache-related disability
timeFrame: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
Secondary outcomes:
measure: Change in sleep quality
timeFrame: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
measure: Change in sleep patterns
timeFrame: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
measure: Change in headache frequency
timeFrame: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
measure: Change in headache pain intensity
timeFrame: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
measure: Change in anxiety symptoms
timeFrame: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
measure: Change in depressive symptoms
timeFrame: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
measure: Change in health-related quality of life as assessed by the Pediatric Quality of Life Inventory 4.0
timeFrame: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Emily Law, PhD
role: PRINCIPAL_INVESTIGATOR
References: