Mechanisms Of Change in Adolescent Pain Self-management

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-26

Study Completion Date

2020-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intervention for Sleep and Pain in Youth: a Randomized Controlled Trial

NCT04936321

Insomnia Migraine Disorders Headache Disorders

ACTIVE_NOT_RECRUITING NA

Intervention for Sleep and Pain in Youth

NCT03137147

Headache Disorders Migraine Disorders Insomnia

COMPLETED NA

Digital CBTI for Comorbid Insomnia in Chronic Migraine

NCT05244889

Insomnia Chronic Migraine Disorders

ACTIVE_NOT_RECRUITING NA

Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study

NCT02688569

Chronic Widespread Pain Chronic Insomnia

COMPLETED NA

Multidimensional Sleep Health Intervention to Optimize Concussion Recovery

NCT07082218

Concussion (Diagnosis) Concussion, Mild Traumatic Brain Injury Treatment +2 more

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain Central Sensitisation Headache

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Web-based CBT (Web-MAP)

Intervention Type BEHAVIORAL

see arm description

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Web-based CBT (Web-MAP)

see arm description

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No