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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04936321
Other study ID # STUDY00003090
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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