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

NCT04936321 | Active Not Recruiting DMC

• 1 other identifier: STUDY00003090
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pediatric; children; adolescent; sleep; pain; headache; cognitive-behavioral therapy

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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

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

Secondary Outcomes (7)

• Change in sleep quality

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

• Change in sleep patterns

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

• Change in headache frequency

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

• Change in headache pain intensity

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

• Change in anxiety symptoms

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

Study Arms (2)

Sleep Education + CBT for Pain

ACTIVE COMPARATOR

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.

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

CBT for Insomnia + CBT for Pain

EXPERIMENTAL

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.

Behavioral: Internet-delivered CBT for Insomnia; Behavioral: Internet-delivered CBT for Pain Management

Interventions

Internet-delivered CBT for Insomnia BEHAVIORAL

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

CBT for Insomnia + CBT for Pain

Internet-delivered CBT for Pain Management BEHAVIORAL

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.

Also known as: Web-MAP (Web-based Management of Adolescent Pain)

CBT for Insomnia + CBT for Pain; Sleep Education + CBT for Pain

Internet-delivered Sleep Education BEHAVIORAL

The program delivers publicly available information about sleep.

Sleep Education + CBT for Pain

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• University of Virginia: collaborator

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• 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.

  PMID: 36635741 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Migraine Disorders; Headache Disorders; Pain; Headache

Interventions

Pain Management

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Headache Disorders, Primary; Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Disease Management; Patient Care Management; Health Services Administration

Study Officials

• Emily Law, PhD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Because all study procedures delivered online, neither study participants nor investigators. care providers, or outcomes assessors will have knowledge of the treatment assignment and thus this trial can be carried out as a double-blinded RCT.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 23, 2021
• Study Start: October 1, 2021
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)