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NCT Number: NCT04043962

Mechanisms Of Change in Adolescent Pain Self-management

The MOCAS Study aims to describe the mechanisms through which sleep deficiency affects youth responses to an online pain self-management intervention over a 6-month period. The study is a single arm trial with repeated measurements using surveys, daily diaries, and actigraphic monitoring.

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Key information

Conditions

Chronic Pain Agnosia Central Sensitisation Headache Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

About this study

The study objective is to characterize how sleep deficiency influences youth's ability to engage with, implement, and benefit from pain self-management intervention. The investigators will recruit a cohort of 80 youth, ages 12 to 17 years, with chronic musculoskeletal, head, or abdominal pain into a single arm trial conducted at one site. Assessments will occur at baseline, immediately after intervention, and repeated at 3 months post-intervention. Mediators will be assessed at mid-treatment (4 weeks). All youth will receive an 8-week internet-delivered pain self-management intervention (WebMAP). Following the recommended Common Data Elements for self-management three self-management processes are measured including patient activation, pain self-efficacy, and self-management skills, and patient-reported outcomes of health (global health, fatigue) and pain (pain symptoms, pain-related disability). Positive and negative affect and executive function are assessed as potential mediators. Sleep deficiency is comprehensively assessed with subjective measures, daily sleep logs, and ambulatory actigraphy monitoring to measure disrupted sleep, amount of sleep, sleep quality, and insomnia symptoms.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 12-17 years old
  • Has chronic pain (for at least 3 months)
  • Has internet access/email address

Exclusion criteria

  • Diagnosis of a serious, comorbid health condition (e.g. cancer, arthritis, cystic fibrosis, lupus, etc.)
  • Parent/adolescent doesn't speak English
  • Active psychosis/suicidal ideation
  • Currently taking stimulating medications
  • Diagnosed sleep disorder (sleep apnea or narcolepsy)
  • Severe cognitive impairment/unable to read at 5th grade level or complete surveys independently

Treatment and study plan

Web-based CBT (Web-MAP)

Behavioral

see arm description

Primary outcomes

  1. Pain Intensity Ratings

    Time frame: Baseline, 12 weeks (post-treatment), 6 months (follow-up)

    Pain intensity will be measured using the 11-point Numerical Rating Scale (NRS) completed by children via daily diary assessments over a 7-day period. Scores range from 0 = no pain to 10 = worst pain imaginable. Scores are averaged at each timeframe with higher scores indicating higher pain intensity.

  2. Pain-related Disability

    Time frame: Baseline, 12 weeks (post-treatment), 6 months (follow-up)

    The Child Activity Limitations Interview (CALI-9) is a daily diary validated to assess perceived difficulty in completing 9 daily activities as a measure of pain-related disability. Responses are rated on a 5-point scale (0-4), summed, and transformed to a 0-100 scale, with higher scores indicating greater perceived difficulty with activities. Youth will provide ratings daily for 7 days on their online diaries at each assessment period. Mean total activity limitations across the reporting period is used in analyses, with higher scores indicating greater disability.

Secondary outcomes

  1. Fatigue

    Time frame: Baseline, 12 weeks (post-treatment), 6 months (follow-up)

    Children will complete ratings of fatigue on the PedsQL Multidimensional Fatigue Scale, which yields three scores for general fatigue, cognitive fatigue, and sleep-rest fatigue. Scores range from 0-100, where higher scores indicate fewer problems with fatigue. It has been widely used in many pediatric chronic health conditions demonstrating strong reliability and validity.

  2. Global Health

    Time frame: Baseline, 12 weeks (post-treatment), 6 months (follow-up)

    Global health will be assessed by child self report with the PROMIS pediatric global health scale, a 7-item measure summarizing a child's physical, mental, and social health into a single score. The seven items are rated on a 1-5 scale based on their frequency over the past week. Raw scores are then transformed to a T-Score metric allowing for comparisons to a general (norm) population with mean of 50 and standard deviation of 10. Higher scores mean that the child's global health is more positive.

  3. Number of Treatment Modules Completed

    Time frame: 12 weeks (post-treatment)

    Measured as the number of pain self-management modules completed by each participant during the intervention period ranging from 0 to 8 modules. Module completion was categorized as no exposure with 0 modules completed vs some exposure with 1-8 modules completed. Module usage information is obtained from the administrative database of the internet program and is stored in real time.

  4. Treatment Acceptability

    Time frame: 12 weeks (post-treatment)

    Measured using the Treatment Evaluation Inventory (TEI) completed via teen report, which includes 9 items that are rated on a 5 point likert scale (1-5) where higher scores indicate greater treatment acceptability. Individual scores are summed for a total ranging from 9 to 45, and scores over 37 indicate moderate treatment acceptability.

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Registry information

Acronym: MOCAS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 2, 2019
Registry last updated
Oct 18, 2022

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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