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

Primary Purpose

Headache Disorders, Migraine Disorders, Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention for Sleep and Pain in Youth
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache Disorders focused on measuring pediatric, children, adolescent, sleep, pain, cognitive-behavioral therapy

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seattle Children's Research Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cognitive-Behavioral Therapy

Arm Description

Intervention for Sleep and Pain in Youth, a 7-session cognitive-behavioral therapy intervention for co-morbid insomnia and headache

Outcomes

Primary Outcome Measures

Feasibility of Intervention Delivery: Number of Completed Intervention Visits
Number of completed intervention visits
Feasibility of Intervention Delivery: Recruitment/Enrollment Rate
Recruitment/Enrollment Rate

Secondary Outcome Measures

Treatment Acceptability and Satisfaction: Treatment Evaluation Inventory Short Form
9-item self-report measure of treatment acceptability and satisfaction, scores range from 9-45, higher scores indicate greater treatment acceptability
Insomnia Severity Index
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
28-item measure of subjective sleep quality, scores range from 28-168, higher scores indicate poorer sleep quality
Pain Questionnaire
Assesses pain frequency, intensity, onset, and duration.
Child Activity Limitations Interview
Assesses pain-related disability

Full Information

First Posted
April 24, 2017
Last Updated
April 17, 2018
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03137147
Brief Title
Intervention for Sleep and Pain in Youth
Acronym
I-SPY
Official Title
Intervention for Sleep and Pain in Youth: A Feasibility Study of Cognitive-Behavioral Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache Disorders, Migraine Disorders, Insomnia
Keywords
pediatric, children, adolescent, sleep, pain, cognitive-behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-Behavioral Therapy
Arm Type
Other
Arm Description
Intervention for Sleep and Pain in Youth, a 7-session cognitive-behavioral therapy intervention for co-morbid insomnia and headache
Intervention Type
Behavioral
Intervention Name(s)
Intervention for Sleep and Pain in Youth
Other Intervention Name(s)
Hybrid cognitive behavioral therapy for insomnia and headache
Intervention Description
See arm description.
Primary Outcome Measure Information:
Title
Feasibility of Intervention Delivery: Number of Completed Intervention Visits
Description
Number of completed intervention visits
Time Frame
6-12 weeks
Title
Feasibility of Intervention Delivery: Recruitment/Enrollment Rate
Description
Recruitment/Enrollment Rate
Time Frame
6-12 weeks
Secondary Outcome Measure Information:
Title
Treatment Acceptability and Satisfaction: Treatment Evaluation Inventory Short Form
Description
9-item self-report measure of treatment acceptability and satisfaction, scores range from 9-45, higher scores indicate greater treatment acceptability
Time Frame
3 months
Title
Insomnia Severity Index
Description
7-item self-report measure of insomnia severity and impact, scores range from 0-28 with higher scores indicating greater insomnia symptoms.
Time Frame
3 months
Title
Adolescent Sleep Wake Scale
Description
28-item measure of subjective sleep quality, scores range from 28-168, higher scores indicate poorer sleep quality
Time Frame
Past 4 weeks
Title
Pain Questionnaire
Description
Assesses pain frequency, intensity, onset, and duration.
Time Frame
Past 2 weeks
Title
Child Activity Limitations Interview
Description
Assesses pain-related disability
Time Frame
Past month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Law, PhD
Organizational Affiliation
University of Washington & Seattle Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27923435
Citation
Palermo TM, Beals-Erickson S, Bromberg M, Law E, Chen M. A Single Arm Pilot Trial of Brief Cognitive Behavioral Therapy for Insomnia in Adolescents with Physical and Psychiatric Comorbidities. J Clin Sleep Med. 2017 Mar 15;13(3):401-410. doi: 10.5664/jcsm.6490.
Results Reference
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PubMed Identifier
24796681
Citation
Eccleston C, Palermo TM, Williams AC, Lewandowski Holley A, Morley S, Fisher E, Law E. Psychological therapies for the management of chronic and recurrent pain in children and adolescents. Cochrane Database Syst Rev. 2014 May 5;2014(5):CD003968. doi: 10.1002/14651858.CD003968.pub4.
Results Reference
background
PubMed Identifier
24484373
Citation
Fales J, Palermo TM, Law EF, Wilson AC. Sleep outcomes in youth with chronic pain participating in a randomized controlled trial of online cognitive-behavioral therapy for pain management. Behav Sleep Med. 2015;13(2):107-23. doi: 10.1080/15402002.2013.845779. Epub 2014 Jan 31.
Results Reference
background
PubMed Identifier
23031311
Citation
Palermo TM, Law E, Churchill SS, Walker A. Longitudinal course and impact of insomnia symptoms in adolescents with and without chronic pain. J Pain. 2012 Nov;13(11):1099-106. doi: 10.1016/j.jpain.2012.08.003. Epub 2012 Sep 30.
Results Reference
background
PubMed Identifier
21030151
Citation
Palermo TM, Wilson AC, Lewandowski AS, Toliver-Sokol M, Murray CB. Behavioral and psychosocial factors associated with insomnia in adolescents with chronic pain. Pain. 2011 Jan;152(1):89-94. doi: 10.1016/j.pain.2010.09.035. Epub 2010 Oct 27.
Results Reference
background
PubMed Identifier
30152164
Citation
Law EF, Wan Tham S, Aaron RV, Dudeney J, Palermo TM. Hybrid Cognitive-Behavioral Therapy Intervention for Adolescents With Co-Occurring Migraine and Insomnia: A Single-Arm Pilot Trial. Headache. 2018 Jul;58(7):1060-1073. doi: 10.1111/head.13355.
Results Reference
derived

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Intervention for Sleep and Pain in Youth

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