Mechanisms Of Change in Adolescent Pain Self-management
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Seattle Children's Hospital
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Pain Intensity Ratings
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Tonya Palermo
Professor, Anesthesiology and Pain Medicine
Seattle Children's Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
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
- Fatigue(Baseline, 12 weeks (post-treatment), 6 months (follow-up))
- Global Health(Baseline, 12 weeks (post-treatment), 6 months (follow-up))
- Number of Treatment Modules Completed(12 weeks (post-treatment))
- Treatment Acceptability(12 weeks (post-treatment))