Intervention for Sleep and Pain in Youth (I-SPY)
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|ClinicalTrials.gov Identifier: NCT03137147|
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : April 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Headache Disorders Migraine Disorders Insomnia||Behavioral: Intervention for Sleep and Pain in Youth||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intervention for Sleep and Pain in Youth: A Feasibility Study of Cognitive-Behavioral Intervention|
|Actual Study Start Date :||October 1, 2016|
|Actual Primary Completion Date :||December 30, 2017|
|Actual Study Completion Date :||December 30, 2017|
Intervention for Sleep and Pain in Youth, a 7-session cognitive-behavioral therapy intervention for co-morbid insomnia and headache
Behavioral: Intervention for Sleep and Pain in Youth
See arm description.
Other Name: Hybrid cognitive behavioral therapy for insomnia and headache
- Feasibility of Intervention Delivery: Number of Completed Intervention Visits [ Time Frame: 6-12 weeks ]Number of completed intervention visits
- Feasibility of Intervention Delivery: Recruitment/Enrollment Rate [ Time Frame: 6-12 weeks ]Recruitment/Enrollment Rate
- Treatment Acceptability and Satisfaction: Treatment Evaluation Inventory Short Form [ Time Frame: 3 months ]9-item self-report measure of treatment acceptability and satisfaction, scores range from 9-45, higher scores indicate greater treatment acceptability
- Insomnia Severity Index [ Time Frame: 3 months ]7-item self-report measure of insomnia severity and impact, scores range from 0-28 with higher scores indicating greater insomnia symptoms.
- Adolescent Sleep Wake Scale [ Time Frame: Past 4 weeks ]28-item measure of subjective sleep quality, scores range from 28-168, higher scores indicate poorer sleep quality
- Pain Questionnaire [ Time Frame: Past 2 weeks ]Assesses pain frequency, intensity, onset, and duration.
- Child Activity Limitations Interview [ Time Frame: Past month ]Assesses pain-related disability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137147
|United States, Washington|
|Seattle Children's Research Institute|
|Seattle, Washington, United States, 98122|
|Principal Investigator:||Emily Law, PhD||University of Washington & Seattle Children's Hospital|