Intervention for Sleep and Pain in Youth: a Randomized Controlled Trial
NCT ID: NCT04936321
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
224 participants
INTERVENTIONAL
2021-10-01
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
11 Years
17 Years
ALL
No
Sponsors
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University of Virginia
OTHER
Seattle Children's Hospital
OTHER
Responsible Party
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Emily Law
Associate Professor
Principal Investigators
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Emily Law, PhD
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
Locations
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Seattle Children's Hospital
Seattle, Washington, United States
Countries
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References
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Law EF, Ritterband L, Zhou C, Palermo TM. Intervention for Sleep and Pain in Youth (ISPY-RCT): protocol for a two-phase randomized controlled trial of sequenced cognitive-behavioral therapy for insomnia and pain management in adolescents with migraine. Trials. 2023 Jan 12;24(1):25. doi: 10.1186/s13063-022-07035-9.
Other Identifiers
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STUDY00003090
Identifier Type: -
Identifier Source: org_study_id