Intervention for Sleep and Pain in Youth

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Headache Disorders, Migraine Disorders, Insomnia

Intervention / Treatment
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* Behavioral: Intervention for Sleep and Pain in Youth


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cognitive-Behavioral Therapy<br>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<br>* See arm description.<br>* Other names: Hybrid cognitive behavioral therapy for insomnia and headache;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Pain Questionnaire | Assesses pain frequency, intensity, onset, and duration. | Past 2 weeks | 
| Child Activity Limitations Interview | Assesses pain-related disability | Past month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, children, adolescent, sleep, pain, cognitive-behavioral therapy