Intervention for Sleep and Pain in Youth: a Randomized Controlled Trial (I-SPY-RCT)

Seattle Children's Healthcare System

Status: Active, not recruiting

Conditions: Headache Disorders; Migraine Disorders; Insomnia

Treatments: Behavioral: Internet-delivered CBT for Insomnia; Behavioral: Internet-delivered Sleep Education; Behavioral: Internet-delivered CBT for Pain Management

Study type: Interventional

Funder types: Other

Identifiers

NCT04936321

STUDY00003090

Details and patient eligibility

About

Insomnia is a common comorbidity among adolescents with migraine. This randomized controlled clinical trial aims to determine efficacy of cognitive-behavioral therapy (CBT) for insomnia, as well as the combined effect of CBT insomnia and pain interventions, on reducing insomnia symptoms and headache-related disability in adolescents with migraine. The long-term goal is to offer effective, tailored self-management interventions that can address migraine and co-morbid sleep problems in adolescence and disrupt a cycle of persistent, disabling migraine from continuing into adulthood.

Full description

This aims of this study are to: 1) test efficacy of cognitive-behavioral therapy (CBT) insomnia intervention for youth with migraine and comorbid insomnia, and 2) investigate how changes in sleep may modify response to CBT pain intervention. Participants will include 250 youth and their parents. Youth will be ages 11-17 years, with migraine (with or without aura, chronic migraine) and comorbid insomnia. In Phase 1, participants will be randomly assigned to receive access to internet-delivered CBT insomnia intervention or internet-delivered sleep education control over 6 weeks. In Phase 2, all participants will receive access to internet-delivered CBT pain intervention over 6 weeks. Assessments will occur at baseline, immediately after Phase 1 intervention, immediately after Phase 2 intervention, and 6 month follow-up.

Enrollment: 224 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 11-17 years old
• Headache present for at least three months and insomnia symptoms for the past month
• Access to the Internet on any web-enabled device

Exclusion criteria

• Non-English speaking
• Diagnosed sleep disorder (e.g. sleep apnea, narcolepsy)
• Unable to read at 5th grade level or complete surveys independently
• A serious comorbid chronic condition (e.g., diabetes, arthritis, cancer)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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224 participants in 2 patient groups

Sleep Education + CBT for Pain

Active Comparator group

Description:

Participants will receive access to internet-delivered sleep education during Phase 1 (6 weeks) of the study followed by internet-delivered CBT for pain management during Phase 2 (6 weeks) of the study.

Treatment:

Behavioral: Internet-delivered CBT for Pain Management

Behavioral: Internet-delivered Sleep Education

CBT for Insomnia + CBT for Pain

Experimental group

Description:

Participants will receive access to internet-delivered CBT for insomnia during Phase 1 (6 weeks) of the study followed by internet-delivered CBT for pain management during Phase 2 (6 weeks) of the study.

Treatment:

Behavioral: Internet-delivered CBT for Pain Management

Behavioral: Internet-delivered CBT for Insomnia