Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based CBT (Web-MAP) | Behavioral | see arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | 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. Scores range from 0-100, where higher scores indicate fewer problems with fatigue. It has been widely used in many pediatric chronic health conditions demonstrating strong reliability and validity. | Baseline, 12 weeks (post-treatment), 6 months (follow-up) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37633572 | Derived | 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. | |
| 36877543 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participant gave consent for did not complete the pre-treatment assessment
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Web-based CBT (Web-MAP): see arm description |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| Post-Treatment |
| |||||||||||||
| Follow-up |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Web-based CBT (Web-MAP): see arm description |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | At Post-Treatment 3 subjects declined to participate or could not be reached, and 5 subjects withdrew from the study. At Follow-up, of the remaining 80 enrolled participants 7 declined to participate or could not be reached. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 weeks (post-treatment), 6 months (follow-up) |
|
Through study completion and follow-up (average of 6 months)
Standard definitions used in clinicaltrials.gov
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Web-based CBT (Web-MAP): see arm description |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tonya Palermo, Professor, Anesthesiology and Pain Medicine, Seattle Children's Hospital | Seattle Children's Hospital | 206-884-4208 | tonya.palermo@seattlechildrens.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2018 | Jul 25, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 3, 2019 | Jul 25, 2022 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D006261 | Headache |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
All participants will receive internet-delivered CBT for pain self-management (Web-MAP).
Not provided
Not provided
Not provided
Not provided
| Global Health | Global health will be assessed by child self report with the PROMIS pediatric global health scale, a 7-item measure summarizing a child's physical, mental, and social health into a single score. The seven items are rated on a 1-5 scale based on their frequency over the past week. Raw scores are then transformed to a T-Score metric allowing for comparisons to a general (norm) population with mean of 50 and standard deviation of 10. Higher scores mean that the child's global health is more positive. | Baseline, 12 weeks (post-treatment), 6 months (follow-up) |
| Number of Treatment Modules Completed | Measured as the number of pain self-management modules completed by each participant during the intervention period ranging from 0 to 8 modules. Module completion was categorized as no exposure with 0 modules completed vs some exposure with 1-8 modules completed. Module usage information is obtained from the administrative database of the internet program and is stored in real time. | 12 weeks (post-treatment) |
| Treatment Acceptability | Measured using the Treatment Evaluation Inventory (TEI) completed via teen report, which includes 9 items that are rated on a 5 point likert scale (1-5) where higher scores indicate greater treatment acceptability. Individual scores are summed for a total ranging from 9 to 45, and scores over 37 indicate moderate treatment acceptability. | 12 weeks (post-treatment) |
| 35283268 | 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. |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Parent education | Count of Participants | Participants |
|
| Annual household income | Count of Participants | Participants |
|
|
|
| Primary | 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. | At Post-Treatment 3 subjects declined to participate or could not be reached, and 5 subjects withdrew from the study. At Follow-up, of the remaining 80 enrolled participants 7 declined to participate or could not be reached. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 weeks (post-treatment), 6 months (follow-up) |
|
|
|
| Secondary | Fatigue | 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. Scores range from 0-100, where higher scores indicate fewer problems with fatigue. It has been widely used in many pediatric chronic health conditions demonstrating strong reliability and validity. | At Post-Treatment 3 subjects declined to participate or could not be reached, and 5 subjects withdrew from the study. At Follow-up, of the remaining 80 enrolled participants 7 declined to participate or could not be reached. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 weeks (post-treatment), 6 months (follow-up) |
|
|
|
| Secondary | Global Health | Global health will be assessed by child self report with the PROMIS pediatric global health scale, a 7-item measure summarizing a child's physical, mental, and social health into a single score. The seven items are rated on a 1-5 scale based on their frequency over the past week. Raw scores are then transformed to a T-Score metric allowing for comparisons to a general (norm) population with mean of 50 and standard deviation of 10. Higher scores mean that the child's global health is more positive. | At Post-Treatment 3 subjects declined to participate or could not be reached, and 5 subjects withdrew from the study. At Follow-up, of the remaining 80 enrolled participants 7 declined to participate or could not be reached. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 weeks (post-treatment), 6 months (follow-up) |
|
|
|
| Secondary | Number of Treatment Modules Completed | Measured as the number of pain self-management modules completed by each participant during the intervention period ranging from 0 to 8 modules. Module completion was categorized as no exposure with 0 modules completed vs some exposure with 1-8 modules completed. Module usage information is obtained from the administrative database of the internet program and is stored in real time. | Number of treatment modules completed by those completing intervention period | Posted | Count of Participants | Participants | 12 weeks (post-treatment) |
|
|
|
| Secondary | Treatment Acceptability | Measured using the Treatment Evaluation Inventory (TEI) completed via teen report, which includes 9 items that are rated on a 5 point likert scale (1-5) where higher scores indicate greater treatment acceptability. Individual scores are summed for a total ranging from 9 to 45, and scores over 37 indicate moderate treatment acceptability. | Teen report of treatment acceptability at post-treatment | Posted | Mean | Standard Deviation | score on a scale | 12 weeks (post-treatment) |
|
|
|
| 0 |
| 85 |
| 0 |
| 85 |
| 0 |
| 85 |
Not provided
Not provided
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
|
| Follow-up |
|
|
|
| Follow-up |
|
|
|
| Follow-up |
|
|