Headache Disorders, Insomnia, Migraine Disorders
Conditions
Keywords
pediatric, children, adolescent, sleep, pain, cognitive-behavioral therapy
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.
Interventions
BEHAVIORALIntervention for Sleep and Pain in Youth
See arm description.
Sponsors
Seattle Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Child Activity Limitations Interview | Past month | Assesses pain-related disability |
| Pain Questionnaire | Past 2 weeks | Assesses pain frequency, intensity, onset, and duration. |
| 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. |
Countries
United States
Outcome results
None listed