Intervention for Sleep and Pain in Youth

Insomnia Clinical Trial

— I-SPY  

Official title:

Intervention for Sleep and Pain in Youth: A Feasibility Study of Cognitive-Behavioral Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137147
• Other study ID #: STUDY00000002
• Status: Completed
• Phase: N/A
• First received: April 24, 2017
• Last updated: April 17, 2018
• Start date: October 1, 2016
• Est. completion date: December 30, 2017

Study information

• Verified date: April 2018
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Headache
• Headache Disorders
• Insomnia
• Migraine Disorders

Intervention

Behavioral:
• Intervention for Sleep and Pain in Youth
See arm description.

Locations

Country	Name	City	State
United States	Seattle Children's Research Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Intervention Delivery: Number of Completed Intervention Visits	Number of completed intervention visits	6-12 weeks
Primary	Feasibility of Intervention Delivery: Recruitment/Enrollment Rate	Recruitment/Enrollment Rate	6-12 weeks
Secondary	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	3 months
Secondary	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.	3 months
Secondary	Adolescent Sleep Wake Scale	28-item measure of subjective sleep quality, scores range from 28-168, higher scores indicate poorer sleep quality	Past 4 weeks
Secondary	Pain Questionnaire	Assesses pain frequency, intensity, onset, and duration.	Past 2 weeks
Secondary	Child Activity Limitations Interview	Assesses pain-related disability	Past month