Intervention for Sleep and Pain in Youth

Not Applicable

Completed

• Conditions: Migraine Disorders; Insomnia; Headache Disorders

• Registration Number: NCT03137147
• Lead Sponsor: Seattle Children's Hospital

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.

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2017-04-24
• Study First Submitted QC: 2017-04-28
• Study First Posted: 2017-05-02
• Primary Completion: 2017-12-30
• Study Completion: 2017-12-30
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of Intervention Delivery: Number of Completed Intervention Visits	6-12 weeks	Number of completed intervention visits
Feasibility of Intervention Delivery: Recruitment/Enrollment Rate	6-12 weeks	Recruitment/Enrollment Rate

Secondary Outcome Measures

Name	Time	Method
Treatment Acceptability and Satisfaction: Treatment Evaluation Inventory Short Form	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	3 months	7-item self-report measure of insomnia severity and impact, scores range from 0-28 with higher scores indicating greater insomnia symptoms.
Adolescent Sleep Wake Scale	Past 4 weeks	28-item measure of subjective sleep quality, scores range from 28-168, higher scores indicate poorer sleep quality
Pain Questionnaire	Past 2 weeks	Assesses pain frequency, intensity, onset, and duration.
Child Activity Limitations Interview	Past month	Assesses pain-related disability

Trial Locations

Locations (1)

Seattle Children's Research Institute; 🇺🇸 Seattle, Washington, United States