Clinical trial NCT04043962: Mechanisms Of Change in Adolescent Pain Self-management
Official title: Mechanisms Of Change in Adolescent Pain Self-management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Central Sensitisation
Headache
Keywords: chronic pain
internet intervention
pain management
CBT
adolescent
sleep
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 85
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive internet-delivered CBT for pain self-management (Web-MAP).
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Pain Intensity Ratings
timeFrame: Baseline, 12 weeks (post-treatment), 6 months (follow-up)
measure: Pain-related Disability
timeFrame: Baseline, 12 weeks (post-treatment), 6 months (follow-up)
Secondary outcomes:
measure: Fatigue
timeFrame: Baseline, 12 weeks (post-treatment), 6 months (follow-up)
measure: Global Health
timeFrame: Baseline, 12 weeks (post-treatment), 6 months (follow-up)
measure: Number of Treatment Modules Completed
timeFrame: 12 weeks (post-treatment)
measure: Treatment Acceptability
timeFrame: 12 weeks (post-treatment)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
References:
citation: Palermo TM, Law EF, Kim A, de la Vega R, Zhou C. Baseline Sleep Disturbances Modify Outcome Trajectories in Adolescents With Chronic Pain Receiving Internet-Delivered Psychological Treatment. J Pain. 2022 Jul;23(7):1245-1255. doi: 10.1016/j.jpain.2022.03.003. Epub 2022 Mar 10.