Intervention for Sleep and Pain in Youth (I-SPY)
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| ClinicalTrials.gov Identifier: NCT03137147 |
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Recruitment Status
:
Completed
First Posted
: May 2, 2017
Last Update Posted
: April 19, 2018
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Sponsor:
Seattle Children's Hospital
Information provided by (Responsible Party):
Emily Law, Seattle Children's Hospital
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Brief Summary:
This study tests the feasibility, acceptability, and preliminary efficacy of a seven-session cognitive-behavioral therapy intervention to treat sleep and pain problems in youth ages 11-17 with co-morbid headache and insomnia.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Headache Disorders Migraine Disorders Insomnia | Behavioral: Intervention for Sleep and Pain in Youth | Not Applicable |
Cognitive-behavioral interventions have been developed to treat childhood insomnia and childhood headache. In this study, we have combined strategies from these interventions into a single, seven-session protocol to treat sleep and pain problems in youth with co-morbid headache and insomnia. In this single-arm pilot study, we will test the feasibility, acceptability, and preliminary efficacy of this intervention.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 21 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Headache
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Cognitive-Behavioral Therapy
Intervention for Sleep and Pain in Youth, a 7-session cognitive-behavioral therapy intervention for co-morbid insomnia and headache
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Behavioral: Intervention for Sleep and Pain in Youth
See arm description.
Other Name: Hybrid cognitive behavioral therapy for insomnia and headache
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Primary Outcome Measures
:
- 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
Secondary Outcome Measures
:
- 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 11 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- youth age 11-17 years
- chronic headache and insomnia symptoms for the past 3 months as determined on screening interview with youth and parent.
Exclusion Criteria:
- youth and parent do not read or speak English
- youth with active suicidal ideation or psychosis
- youth with diagnosis of a comorbid serious health condition (e.g., cancer, diabetes)
- youth with severe cognitive impairment
- youth with another primary sleep disorder (e.g., sleep apnea, narcolepsy) or an unusual sleep/wake schedule or circadian rhythm disorder.
Information from the National Library of Medicine
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
Locations
| United States, Washington | |
| Seattle Children's Research Institute | |
| Seattle, Washington, United States, 98122 | |
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
| Principal Investigator: | Emily Law, PhD | University of Washington & Seattle Children's Hospital |
Publications:
| Responsible Party: | Emily Law, Assistant Professor, Anesthesiology & Pain Medicine, Seattle Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT03137147 History of Changes |
| Other Study ID Numbers: |
STUDY00000002 |
| First Posted: | May 2, 2017 Key Record Dates |
| Last Update Posted: | April 19, 2018 |
| Last Verified: | April 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Emily Law, Seattle Children's Hospital:
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pediatric children adolescent |
sleep pain cognitive-behavioral therapy |
Additional relevant MeSH terms:
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Migraine Disorders Disease Headache Headache Disorders Pathologic Processes Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms Headache Disorders, Primary Brain Diseases Central Nervous System Diseases |