Intervention for Sleep and Pain in Youth

NCT03137147 | Completed

• 1 other identifier: STUDY00000002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache Disorders; Migraine Disorders; Insomnia

Keywords

pediatric; children; adolescent; sleep; pain; cognitive-behavioral therapy

Outcome Measures

Primary Outcomes (2)

• Feasibility of Intervention Delivery: Number of Completed Intervention Visits

  Number of completed intervention visits

  6-12 weeks

• Feasibility of Intervention Delivery: Recruitment/Enrollment Rate

  Recruitment/Enrollment Rate

  6-12 weeks

Secondary Outcomes (5)

• Treatment Acceptability and Satisfaction: Treatment Evaluation Inventory Short Form

  3 months

• Insomnia Severity Index

  3 months

• Adolescent Sleep Wake Scale

  Past 4 weeks

• Pain Questionnaire

  Past 2 weeks

• Child Activity Limitations Interview

  Past month

Study Arms (1)

Cognitive-Behavioral Therapy

OTHER

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

Interventions

Intervention for Sleep and Pain in Youth BEHAVIORAL

See arm description.

Also known as: Hybrid cognitive behavioral therapy for insomnia and headache

Cognitive-Behavioral Therapy

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• youth age 11-17 years
• chronic headache and insomnia symptoms for the past 3 months as determined on screening interview with youth and parent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Research Institute

Seattle, Washington, 98122, United States

Location

Related Publications (6)

• 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.

  PMID: 27923435 BACKGROUND

• 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.

  PMID: 24796681 BACKGROUND

• 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.

  PMID: 24484373 BACKGROUND

• 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.

  PMID: 23031311 BACKGROUND

• 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.

  PMID: 21030151 BACKGROUND

• 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.

  PMID: 30152164 DERIVED

MeSH Terms

Conditions

Headache Disorders; Migraine Disorders; Sleep Initiation and Maintenance Disorders; Pain

Interventions

Methods; Sleep

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Emily Law, PhD

  University of Washington & Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Anesthesiology & Pain Medicine

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 2, 2017
• Study Start: October 1, 2016
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

US (1)