- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04043962
Mechanisms Of Change in Adolescent Pain Self-management (MOCAS)
September 24, 2022 updated by: Tonya Palermo, Seattle Children's Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
85
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Washington
-
Seattle, Washington, United States, 98105
- Seattle Children's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Web-based CBT (Web-MAP)
The eight child modules include: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) deep breathing and relaxation, 4) implementing coping skills at school, 5) cognitive skills (e.g., reducing negative thoughts), 6) lifestyle interventions, 7) staying active (e.g., pleasant activity scheduling), 8) relapse prevention.
The eight parent modules are: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) operant strategies I (using attention and praise to increase coping), 4) operant strategies II (using rewards to increase positive coping and reach school goals), 5) modeling, 6) lifestyle, 7) communication, 8) relapse prevention.
|
see arm description
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline, 12 weeks (post-treatment), 6 months (follow-up)
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Pain-related Disability
Time Frame: Baseline, 12 weeks (post-treatment), 6 months (follow-up)
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline, 12 weeks (post-treatment), 6 months (follow-up)
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Global Health
Time Frame: Baseline, 12 weeks (post-treatment), 6 months (follow-up)
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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.
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Baseline, 12 weeks (post-treatment), 6 months (follow-up)
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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.
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12 weeks (post-treatment)
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Treatment Acceptability
Time Frame: 12 weeks (post-treatment)
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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.
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12 weeks (post-treatment)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 26, 2018
Primary Completion (ACTUAL)
October 31, 2020
Study Completion (ACTUAL)
October 31, 2020
Study Registration Dates
First Submitted
July 31, 2019
First Submitted That Met QC Criteria
August 1, 2019
First Posted (ACTUAL)
August 2, 2019
Study Record Updates
Last Update Posted (ACTUAL)
October 18, 2022
Last Update Submitted That Met QC Criteria
September 24, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21NR017312 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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