Mechanisms Of Change in Adolescent Pain Self-management

NCT04043962 | Completed Results

• 1 other identifier: R21NR017312
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Central Sensitisation; Headache

Keywords

chronic pain; internet intervention; pain management; CBT; adolescent; sleep

Outcome Measures

Primary Outcomes (2)

• Pain Intensity Ratings

  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.

  Baseline, 12 weeks (post-treatment), 6 months (follow-up)

• Pain-related Disability

  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)

Secondary Outcomes (4)

• Fatigue

  Baseline, 12 weeks (post-treatment), 6 months (follow-up)

• Global Health

  Baseline, 12 weeks (post-treatment), 6 months (follow-up)

• Number of Treatment Modules Completed

  12 weeks (post-treatment)

• Treatment Acceptability

  12 weeks (post-treatment)

Study Arms (1)

Web-based CBT (Web-MAP)

EXPERIMENTAL

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)

Interventions

Web-based CBT (Web-MAP) BEHAVIORAL

see arm description

Web-based CBT (Web-MAP)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years old
• Has chronic pain (for at least 3 months)
• Has internet access/email address

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (3)

• Law EF, Tham SW, Howard W, Ward TM, Palermo TM. Executive Functioning and Self-Management Processes Mediate the Relationship Between Insomnia and Pain-Related Disability. J Pain. 2024 Jan;25(1):273-283. doi: 10.1016/j.jpain.2023.08.010. Epub 2023 Aug 24.

  PMID: 37633572 DERIVED

• de la Vega R, Palermo TM. Mediating Role of Treatment Perceptions in the Relationship Between Individual Characteristics and Engagement With a Digital Psychological Intervention for Pediatric Chronic Pain: Secondary Data Analysis. JMIR Pediatr Parent. 2023 Mar 6;6:e42399. doi: 10.2196/42399.

  PMID: 36877543 DERIVED

• 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.

  PMID: 35283268 DERIVED

MeSH Terms

Conditions

Chronic Pain; Headache; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Limitations and Caveats

Findings may not generalize to more demographically diverse samples, and patients with specific pain conditions. Can't determine mediators of treatment effects since it was a single arm trial.

Results Point of Contact

• Title: Tonya Palermo, Professor, Anesthesiology and Pain Medicine, Seattle Children's Hospital
• Organization: Seattle Children's Hospital

tonya.palermo@seattlechildrens.org

206-884-4208

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Anesthesiology and Pain Medicine

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

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 2, 2019
• Study Start: November 26, 2018
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: October 18, 2022
• Results First Posted: October 18, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)