MedTrace Logo

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

NCT04936321 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2024-12-17

No results posted yet for this study

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 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.

Conditions

  • Insomnia
  • Migraine Disorders
  • Headache Disorders

Interventions

BEHAVIORAL

Internet-delivered CBT for Insomnia

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

BEHAVIORAL

Internet-delivered CBT for Pain Management

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.

BEHAVIORAL

Internet-delivered Sleep Education

The program delivers publicly available information about sleep.

Sponsors & Collaborators

  • University of Virginia

    collaborator OTHER

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Emily Law, PhD · Seattle Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04936321 on ClinicalTrials.gov