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

This study is currently recruiting participants.
Verified October 2017 by Emily Law, Seattle Children's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03137147
First Posted: May 2, 2017
Last Update Posted: October 4, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Emily Law, Seattle Children's Hospital
  Purpose
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 Insomnia Behavioral: Intervention for Sleep and Pain in Youth

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Emily Law, 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, 2018
Estimated Primary Completion Date: June 2, 2018 (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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
  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


Contacts
Contact: Emily Law, PhD emily.law@seattlechildrens.org

Locations
United States, Washington
Seattle Children's Research Institute Recruiting
Seattle, Washington, United States, 98122
Contact: Emily Law, PhD       emily.law@seattlechildrens.org   
Principal Investigator: Emily Law, PhD         
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Principal Investigator: Emily Law, PhD University of Washington & Seattle Children's Hospital
  More Information

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 Submitted: April 24, 2017
First Posted: May 2, 2017
Last Update Posted: October 4, 2017
Last Verified: October 2017
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:
pediatric
children
adolescent
sleep
pain
cognitive-behavioral therapy

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