MOCAS: Mechanisms Of Change in Adolescent Pain Self-management

Sponsor

Seattle Children's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04043962

Collaborator

(none)

Enrollment

Location

Arm

23.2

Actual Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

All participants will receive internet-delivered CBT for pain self-management (Web-MAP).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 :

Nov 26, 2018

Actual Primary Completion Date :

Oct 31, 2020

Actual Study Completion Date :

Oct 31, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in pain intensity ratings [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 [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

Change in fatigue [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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