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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Central Sensitisation Headache||Behavioral: Web-based CBT (Web-MAP)||Not Applicable|
|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)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Tonya M Palermo, PhDfirstname.lastname@example.org|
|Contact: Tricia Fiddick, BSemail@example.com|
|United States, Washington|
|Seattle Children's Hospital||Recruiting|
|Seattle, Washington, United States, 98105|
|Contact: Tonya M Palermo, PhD 206-884-4208 firstname.lastname@example.org|