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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Seattle Children's Hospital
Information provided by (Responsible Party):
Emily Law, Seattle Children's Hospital Identifier:
First received: April 24, 2017
Last updated: April 28, 2017
Last verified: April 2017
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 Intervention
Headache Disorders
Migraine Disorders
Behavioral: Intervention for Sleep and Pain in Youth

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Intervention for Sleep and Pain in Youth: A Feasibility Study of Cognitive-Behavioral Intervention

Resource links provided by NLM:

Further study details as provided by Seattle Children's Hospital:

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.

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

  • 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

Estimated Enrollment: 25
Actual Study Start Date: February 2, 2016
Estimated Study Completion Date: October 2, 2017
Estimated Primary Completion Date: June 2, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT03137147

Contact: Emily Law, PhD

United States, Washington
Seattle Children's Research Institute Recruiting
Seattle, Washington, United States, 98122
Contact: Emily Law, PhD   
Principal Investigator: Emily Law, PhD         
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 Identifier: NCT03137147     History of Changes
Other Study ID Numbers: STUDY00000002
Study First Received: April 24, 2017
Last Updated: April 28, 2017
Individual Participant Data  
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 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 processed this record on May 25, 2017