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InsomniaI-SPY-RCTNCT04936321

Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial

A study testing Internet-delivered CBT for Insomnia, Internet-delivered CBT for Pain Management and Internet-delivered Sleep Education in people with Insomnia and Migraine Disorders, run by Seattle Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 11 to 17 years
Conditions the study is for
Insomnia, Migraine Disorders, Headache Disorders
What is being tested?
Internet-delivered CBT for Insomnia, Internet-delivered CBT for Pain Management and Internet-delivered Sleep Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
1 siteUnited States
Study dates
1 Oct 2021to 6 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Seattle Children's Hospital

    Seattle, Washington, 98105

Other trials in United States

About this study

Official title: Enhancing the Efficacy of Migraine Self-Management in Children With Comorbid Insomnia

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.

Read the detailed 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.

Being tested
Internet-delivered CBT for Insomnia, Internet-delivered CBT for Pain Management, Internet-delivered Sleep Education
Keywords
pediatric, children, adolescent, sleep, pain, headache, cognitive-behavioral therapy
Medical subject headings
Sleep Initiation and Maintenance Disorders, Migraine Disorders, Headache Disorders, Pain, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet-delivered CBT for InsomniaBehavioural

    The program delivers the core components of CBT for insomnia including sleep hygiene, stimulus control, and sleep restriction. Treatment duration is 6 weeks.

  • Internet-delivered CBT for Pain ManagementBehavioural

    Also called Web-MAP (Web-based Management of Adolescent Pain)

    The program delivers the core components of CBT for pain management including: pain education, training in behavioral and cognitive pain coping skills, instruction in increasing activity participation, and training in parental operant and communication strategies. Treatment duration is 6 weeks.

  • Internet-delivered Sleep EducationBehavioural

    The program delivers publicly available information about sleep.

Study groups in NCT04936321
Study groupRoleWhat they receive
Sleep Education + CBT for PainActive comparatorParticipants 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.
Receives: Behavioral: Internet-delivered CBT for Pain Management; Behavioral: Internet-delivered Sleep Education
CBT for Insomnia + CBT for PainExperimentalParticipants 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.
Receives: Behavioral: Internet-delivered CBT for Insomnia; Behavioral: Internet-delivered CBT for Pain Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in insomnia symptoms

    The 7-item Insomnia Severity Index (ISI) measures severity of insomnia symptoms. Total scores above 8 on the ISI indicate clinically significant insomnia in adult and adolescent samples.

    Measured: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

  2. Change in headache-related disability

    The CALI-9 is a 9-item self-report instrument of headache-related disability in children and adolescents that measures difficulty in performing usual daily physical, social, and recreational activities. The measure will be completed daily for 14 days at baseline, after phase 1, after phase 2, and 6-month follow-up

    Measured: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

Secondary outcomes (7)

  1. Change in sleep quality

    The Adolescent Sleep Wake Scale-Short Form (ASWS) is a 10-item measure. The total score indicates overall perception of sleep quality.

    Measured: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

  2. Change in sleep patterns

    14-days of actigraphic monitoring with the Actiwatch Spectrum Plus to assess minutes of estimated sleep, wake time after sleep onset, and sleep efficiency.

    Measured: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

  3. Change in headache frequency

    The number of headache days reported each day for 14 days.

    Measured: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

  4. Change in headache pain intensity

    11-point numerical rating scale with anchors of 0 = no pain to 10 = worst pain possible. Reported each day for 14 days.

    Measured: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

  5. Change in anxiety symptoms

    The Generalized Anxiety Disorder-7 is a 7-item measure. The total score indicates anxiety severity over the last two weeks.

    Measured: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

  6. Change in depressive symptoms

    The Patient Health Questionnaire-9 is a 9 item measure. The total score indicates severity of depression over the last two weeks.

    Measured: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

  7. Change in health-related quality of life as assessed by the Pediatric Quality of Life Inventory 4.0

    The Pediatric Quality of Life Inventory 4.0. is a measure of health-related quality of life. The total score indicates perceived mental and physical health.

    Measured: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2021
  2. Study start1 Oct 2021
  3. Primary completion12 Mar 2026
  4. Study completion6 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study design is a two arm, two-phase RCT. In Phase 1, the effects of internet-delivered CBT insomnia intervention will be compared to internet-delivered sleep education control. In Phase 2, all participants will receive internet-delivered CBT pain intervention.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04936321
Sponsor's protocol ID
STUDY00003090
Acronym
I-SPY-RCT
Status last verified
Jul 2026
First submitted
8 Jun 2021
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Law EF, Ritterband L, Zhou C, Palermo TM. Intervention for Sleep and Pain in Youth (ISPY-RCT): protocol for a two-phase randomized controlled trial of sequenced cognitive-behavioral therapy for insomnia and pain management in adolescents with migraine. Trials. 2023 Jan 12;24(1):25. doi: 10.1186/s13063-022-07035-9.

    PubMed 36635741

Questions about this trial

What is this clinical trial studying?

A study testing Internet-delivered CBT for Insomnia, Internet-delivered CBT for Pain Management and Internet-delivered Sleep Education in people with Insomnia and Migraine Disorders, run by Seattle Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in insomnia symptoms (time frame: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04936321, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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