ArticleTrials2023
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.
Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04936321 (Enhancing the Efficacy of Migraine Self-Management in Children With Comorbid Insomnia), which is not on this map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Enhancing the Efficacy of Migraine Self-Management in Children With Comorbid Insomnia
Who cites it
8 citing papers in PubMed, 12 citations in OpenAlex.
- Executive Functioning and Self-Management Processes Mediate the Relationship Between Insomnia and Pain-Related Disability.The journal of pain · 2024Trial
- Detecting the Non-Dipper Phenotype in Adolescents Exposed to Nighttime Screen Use-Digital Chronotoxicity as a Proposed Integrative Framework: A Narrative Review of Ambulatory Blood Pressure Monitoring, Subclinical Biomarkers, and Emerging Wearable and AI-Based Screening.Diagnostics (Basel, Switzerland) · 2026Review
- Digital Media Use in Adolescents with Migraine: A Topical Review.Current pain and headache reports · 2025Review
- Evaluation and treatment of sleep disorders in adolescents with depression; a scoping review.BMC psychiatry · 2025Article
- Supporting Students with Migraine: Examining Current Practices and Identifying Strategies for Educational Success.Current pain and headache reports · 2025Review
- Sleep Symptoms in Migraine.Current neurology and neuroscience reports · 2024Review
- Article
- Sleep Symptoms and Disorders in Episodic Migraine: Assessment and Management.Current pain and headache reports · 2023Review
Corrections and comments
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Authors and funding
4 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundMigraine is a major pediatric health problem impacting 10-12% of youth. About 1 in 3 youth with migraine are diagnosed with insomnia. Sleep and migraine share a cyclical relationship, and data indicate that insomnia symptoms increase migraine severity. CBT for insomnia (CBT-I) has demonstrated efficacy for improving insomnia in adults with migraine and other pain conditions; however, effects in youth have not been evaluated. Moreover, in adults, there is some indication that CBT-I may lead to changes in pain after there are sustained improvements in sleep, but this has never been empirically tested. Cognitive-behavioral therapy for pain management (CBT-Pain) is an established treatment approach for youth with migraine, leading to reductions in headache frequency and disability. In the proposed study, we will address these gaps in knowledge by using an innovative two-phase trial design to (1) test the efficacy of Internet-delivered CBT-I intervention for youth with migraine and comorbid insomnia compared to Internet-delivered sleep education for modifying sleep and (2) investigate how changes in sleep may modify the response to Internet-delivered CBT-Pain intervention.
methodsWe will study a cohort of 180 adolescents, ages 11-17 years, with migraine (with or without aura, chronic migraine) and comorbid insomnia. In phase 1, youth will be randomly assigned to receive Internet-delivered CBT-I intervention or Internet sleep education control. In phase 2, all youth will receive Internet-delivered CBT-Pain intervention. Assessments will occur at baseline, immediately after phase 1 intervention, immediately after phase 2 intervention, and 6 months post-intervention. We will use a comprehensive multidimensional assessment of sleep and headache including self-report questionnaires, ambulatory actigraphy monitoring, and 14-day daily diaries. DISCUSSION: Given the high prevalence of insomnia in adolescents with migraine, an extension of CBT-I intervention to this population will address an important gap in clinical practice and in conceptual understanding of the relationship between sleep and migraine. By testing a separate CBT-I intervention, we will be able to apply this treatment in the future to other pediatric populations (e.g., cancer, arthritis) who commonly experience comorbid insomnia.
trial registrationClinicalTrials.gov NCT04936321. Registered on June 23, 2021.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.