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Intervention for Sleep and Pain in Youth (I-SPY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03137147
Recruitment Status : Active, not recruiting
First Posted : May 2, 2017
Last Update Posted : January 18, 2018
Information provided by (Responsible Party):

Study Description
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
Headache Disorders Migraine Disorders Insomnia Behavioral: Intervention for Sleep and Pain in Youth

Detailed Description:
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 Design

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
Estimated Primary Completion Date : February 2, 2018
Estimated Study Completion Date : February 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Cognitive-Behavioral Therapy
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.

Outcome Measures

Primary Outcome Measures :
  1. Feasibility of Intervention Delivery: Number of Completed Intervention Visits [ Time Frame: 6-12 weeks ]
    Number of completed intervention visits

  2. Feasibility of Intervention Delivery: Recruitment/Enrollment Rate [ Time Frame: 6-12 weeks ]
    Recruitment/Enrollment Rate

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Actigraphy [ Time Frame: Prospective over 7 days ]
    Actiwatch will be worn to monitor sleep and activity levels for 7 days and nights.

  4. 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

  5. Pain Questionnaire [ Time Frame: Past 2 weeks ]
    Assesses pain frequency, intensity, onset, and duration.

  6. Child Activity Limitations Interview [ Time Frame: Past month ]
    Assesses pain-related disability

Eligibility Criteria

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

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.
Contacts and Locations

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

United States, Washington
Seattle Children's Research Institute
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Seattle Children's Hospital
Principal Investigator: Emily Law, PhD University of Washington & Seattle Children's Hospital
More Information

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: January 18, 2018
Last Verified: January 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:
cognitive-behavioral therapy

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Brain Diseases
Central Nervous System Diseases