Mechanisms Of Change in Adolescent Pain Self-management

Chronic Pain Clinical Trial

— MOCAS  

Official title:

Mechanisms Of Change in Adolescent Pain Self-management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04043962
• Other study ID #: R21NR017312
• Status: Completed
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: September 2022
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Sensitisation
• Chronic Pain
• Headache

Intervention

Behavioral:
• Web-based CBT (Web-MAP)
see arm description

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity Ratings	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.	Baseline, 12 weeks (post-treatment), 6 months (follow-up)
Primary	Pain-related Disability	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.	Baseline, 12 weeks (post-treatment), 6 months (follow-up)
Secondary	Fatigue	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.	Baseline, 12 weeks (post-treatment), 6 months (follow-up)
Secondary	Global Health	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.	Baseline, 12 weeks (post-treatment), 6 months (follow-up)
Secondary	Number of Treatment Modules Completed	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.	12 weeks (post-treatment)
Secondary	Treatment Acceptability	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.	12 weeks (post-treatment)