Intervention for Sleep and Pain in Youth

NCT ID: NCT03137147

Last Updated: 2018-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2017-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Headache Disorders Migraine Disorders Insomnia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cognitive-Behavioral Therapy

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

Group Type OTHER

Intervention for Sleep and Pain in Youth

Intervention Type BEHAVIORAL

See arm description.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention for Sleep and Pain in Youth

See arm description.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Hybrid cognitive behavioral therapy for insomnia and headache

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Emily Law

Assistant Professor, Anesthesiology & Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emily Law, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington & Seattle Children's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seattle Children's Research Institute

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27923435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24796681 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24484373 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23031311 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21030151 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30152164 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00000002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Young Adult and Teen Sleep Study
NCT00949689 COMPLETED PHASE2