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Completed

NCT Number: NCT03137147

Intervention for Sleep and Pain in Youth

This study tests the feasibility, acceptability, and preliminary efficacy of a seven-session cognitive-behavioral therapy intervention to treat sleep and pain problems in youth ages 11-17 with co-morbid headache and insomnia.

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Key information

Conditions

Headache Disorders Brain Diseases Central Nervous System Diseases Dyssomnias Headache Disorders, Primary Insomnia Mental Disorders Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Research Institute

Seattle, Washington, 98122, United States

About this study

Cognitive-behavioral interventions have been developed to treat childhood insomnia and childhood headache. In this study, we have combined strategies from these interventions into a single, seven-session protocol to treat sleep and pain problems in youth with co-morbid headache and insomnia. In this single-arm pilot study, we will test the feasibility, acceptability, and preliminary efficacy of this intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • youth age 11-17 years
  • chronic headache and insomnia symptoms for the past 3 months as determined on screening interview with youth and parent.

Exclusion criteria

  • youth and parent do not read or speak English
  • youth with active suicidal ideation or psychosis
  • youth with diagnosis of a comorbid serious health condition (e.g., cancer, diabetes)
  • youth with severe cognitive impairment
  • youth with another primary sleep disorder (e.g., sleep apnea, narcolepsy) or an unusual sleep/wake schedule or circadian rhythm disorder.

Treatment and study plan

Intervention for Sleep and Pain in Youth

Behavioral

See arm description.

Other names: Hybrid cognitive behavioral therapy for insomnia and headache

Primary outcomes

  1. Feasibility of Intervention Delivery: Number of Completed Intervention Visits

    Time frame: 6-12 weeks

    Number of completed intervention visits

  2. Feasibility of Intervention Delivery: Recruitment/Enrollment Rate

    Time frame: 6-12 weeks

    Recruitment/Enrollment Rate

Secondary outcomes

  1. Treatment Acceptability and Satisfaction: Treatment Evaluation Inventory Short Form

    Time frame: 3 months

    9-item self-report measure of treatment acceptability and satisfaction, scores range from 9-45, higher scores indicate greater treatment acceptability

  2. Insomnia Severity Index

    Time frame: 3 months

    7-item self-report measure of insomnia severity and impact, scores range from 0-28 with higher scores indicating greater insomnia symptoms.

  3. Adolescent Sleep Wake Scale

    Time frame: Past 4 weeks

    28-item measure of subjective sleep quality, scores range from 28-168, higher scores indicate poorer sleep quality

  4. Pain Questionnaire

    Time frame: Past 2 weeks

    Assesses pain frequency, intensity, onset, and duration.

  5. Child Activity Limitations Interview

    Time frame: Past month

    Assesses pain-related disability

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Registry information

Official study title

Intervention for Sleep and Pain in Youth: A Feasibility Study of Cognitive-Behavioral Intervention

Acronym: I-SPY

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 2, 2017
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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