Clinical trial NCT03137147: Intervention for Sleep and Pain in Youth
Official title: Intervention for Sleep and Pain in Youth: A Feasibility Study of Cognitive-Behavioral Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache Disorders
Migraine Disorders
Insomnia
Keywords: pediatric
children
adolescent
sleep
pain
cognitive-behavioral therapy
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 21
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Feasibility of Intervention Delivery: Number of Completed Intervention Visits
timeFrame: 6-12 weeks
measure: Feasibility of Intervention Delivery: Recruitment/Enrollment Rate
timeFrame: 6-12 weeks
Secondary outcomes:
measure: Treatment Acceptability and Satisfaction: Treatment Evaluation Inventory Short Form
timeFrame: 3 months
measure: Insomnia Severity Index
timeFrame: 3 months
measure: Adolescent Sleep Wake Scale
timeFrame: Past 4 weeks
measure: Pain Questionnaire
timeFrame: Past 2 weeks
measure: Child Activity Limitations Interview
timeFrame: Past month
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
Study officials:
affiliation: University of Washington & Seattle Children's Hospital
name: Emily Law, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.