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

This study is currently recruiting participants.

See

Contacts and Locations

Verified April 2017 by Emily Law, Seattle Children's Hospital

Sponsor:

Information provided by (Responsible Party):

Emily Law, Seattle Children's Hospital

ClinicalTrials.gov Identifier:

NCT03137147

First received: April 24, 2017

Last updated: April 28, 2017

Last verified: April 2017

History of Changes

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: 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:

MedlinePlus related topics: Headache

U.S. FDA Resources

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, 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.

Eligibility


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

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 ClinicalTrials.gov identifier: 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:

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.

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;(5):CD003968. doi: 10.1002/14651858.CD003968.pub4. Review.

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.

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.

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.


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
Study First Received:	April 24, 2017
Last Updated:	April 28, 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:


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

ClinicalTrials.gov processed this record on July 28, 2017

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