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Mechanisms Of Change in Adolescent Pain Self-management (MOCAS)

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ClinicalTrials.gov Identifier: NCT04043962
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Tonya Palermo, Seattle Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Central Sensitisation Headache Behavioral: Web-based CBT (Web-MAP) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will receive internet-delivered CBT for pain self-management (Web-MAP).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mechanisms Of Change in Adolescent Pain Self-management
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

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




Primary Outcome Measures :
  1. Change in pain intensity ratings [ Time Frame: Baseline, 12 weeks, 6 months ]
    Pain intensity will be measured using the 11-point NRS (numerical rating scale) completed by children via daily diary assessments over a 7-day period. Scores are averaged at each timeframe with higher scores indicating higher pain intensity.

  2. Change in pain-related disability [ Time Frame: Baseline, 12 weeks, 6 months ]
    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) 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 Outcome Measures :
  1. Change in fatigue [ Time Frame: Baseline, 12 weeks, 6 months ]
    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. Higher scores indicate fewer problems with fatigue. It has been widely used in many pediatric chronic health conditions demonstrating strong reliability and validity.

  2. Change in global health [ Time Frame: Baseline, 12 weeks, 6 months ]
    Global health will be assessed by child self report with the PROMIS pediatric global health measure, a 7-item measure summarizing a child's physical, mental, and social health into a single score. Higher scores indicate better global health.

  3. Number of treatment modules completed [ Time Frame: 12 weeks ]
    Measured as the number of pain self-management modules completed by each participant during the intervention period ranging from 0 to 8 modules. 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 ]
    Measured using the Treatment Evaluation Inventory (TEI) completed via child and parent report, which includes 9 items that are rated on a 5 point likert scales. Higher scores indicate greater treatment acceptability and scores over 37 indicate moderate treatment acceptability.



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04043962


Contacts
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Contact: Tonya M Palermo, PhD 206-884-4208 tonya.palermo@seattlechildrens.org
Contact: Tricia Fiddick, BS 206-884-1308 tricia.fiddick@seattlechildrens.org

Locations
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United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Tonya M Palermo, PhD    206-884-4208    tonya.palermo@seattlechildrens.org   
Sponsors and Collaborators
Seattle Children's Hospital

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Responsible Party: Tonya Palermo, Professor, Anesthesiology and Pain Medicine, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT04043962     History of Changes
Other Study ID Numbers: R21NR017312 ( U.S. NIH Grant/Contract )
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tonya Palermo, Seattle Children's Hospital:
chronic pain
internet intervention
pain management
CBT
adolescent
sleep
Additional relevant MeSH terms:
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Chronic Pain
Headache
Pain
Neurologic Manifestations
Signs and Symptoms