ClinicalTrials.Veeva

Menu

Intervention for Sleep and Pain in Youth (I-SPY)

Seattle Children's Healthcare System logo

Seattle Children's Healthcare System

Status

Completed

Conditions

Headache Disorders
Migraine Disorders
Insomnia

Treatments

Behavioral: Intervention for Sleep and Pain in Youth

Study type

Interventional

Funder types

Other

Identifiers

NCT03137147
STUDY00000002

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

11 to 17 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

21 participants in 1 patient group

Cognitive-Behavioral Therapy
Other group
Description:
Intervention for Sleep and Pain in Youth, a 7-session cognitive-behavioral therapy intervention for co-morbid insomnia and headache
Treatment:
Behavioral: Intervention for Sleep and Pain in Youth

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems