Central Sensitisation, Chronic Pain, Headache
Conditions
Keywords
chronic pain, internet intervention, pain management, CBT, adolescent, sleep
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.
Interventions
BEHAVIORALWeb-based CBT (Web-MAP)
see arm description
Sponsors
Seattle Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants will receive internet-delivered CBT for pain self-management (Web-MAP).
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Ratings | Baseline, 12 weeks (post-treatment), 6 months (follow-up) | 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. |
| Pain-related Disability | Baseline, 12 weeks (post-treatment), 6 months (follow-up) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | Baseline, 12 weeks (post-treatment), 6 months (follow-up) | 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. |
| Global Health | Baseline, 12 weeks (post-treatment), 6 months (follow-up) | 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. |
| Number of Treatment Modules Completed | 12 weeks (post-treatment) | 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. |
| Treatment Acceptability | 12 weeks (post-treatment) | 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. |
Countries
United States
Participant flow
Pre-assignment details
Participant gave consent for did not complete the pre-treatment assessment
Participants by arm
| Arm | Count |
|---|---|
| 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 | 85 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Follow-up | Declined due to lack of time/interest or could not be reached | 7 |
| Post-Treatment | Declined due to lack of time/interest or could not be reached | 3 |
| Post-Treatment | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Web-based CBT (Web-MAP) |
|---|---|
| Age, Categorical <=18 years | 85 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 15.5 years STANDARD_DEVIATION 1.5 |
| Annual household income $100,000 or more | 35 Participants |
| Annual household income $49,999 or less | 24 Participants |
| Annual household income $50,000 - $99,999 | 25 Participants |
| Annual household income Not reported | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Parent education College or vocational school | 60 Participants |
| Parent education Graduate or professional school | 20 Participants |
| Parent education High school or less | 4 Participants |
| Parent education Not reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 64 Participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 85 |
| other Total, other adverse events | 0 / 85 |
| serious Total, serious adverse events | 0 / 85 |
Outcome results
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.
Time frame: Baseline, 12 weeks (post-treatment), 6 months (follow-up)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Web-based CBT (Web-MAP) | Pain Intensity Ratings | Baseline | 5.86 score on a scale | Standard Deviation 1.66 |
| Web-based CBT (Web-MAP) | Pain Intensity Ratings | Post-Treatment | 5.64 score on a scale | Standard Deviation 1.54 |
| Web-based CBT (Web-MAP) | Pain Intensity Ratings | Follow-up | 5.45 score on a scale | Standard Deviation 1.66 |
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.
Time frame: Baseline, 12 weeks (post-treatment), 6 months (follow-up)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Web-based CBT (Web-MAP) | Pain-related Disability | Baseline | 48.33 score on a scale | Standard Deviation 21.84 |
| Web-based CBT (Web-MAP) | Pain-related Disability | Post-Treatment | 44.48 score on a scale | Standard Deviation 22.52 |
| Web-based CBT (Web-MAP) | Pain-related Disability | Follow-up | 44.45 score on a scale | Standard Deviation 23.4 |
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.
Time frame: Baseline, 12 weeks (post-treatment), 6 months (follow-up)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Web-based CBT (Web-MAP) | Fatigue | Baseline | 44.58 score on a scale | Standard Deviation 18.24 |
| Web-based CBT (Web-MAP) | Fatigue | Post-Treatment | 48.71 score on a scale | Standard Deviation 15.7 |
| Web-based CBT (Web-MAP) | Fatigue | Follow-up | 47.79 score on a scale | Standard Deviation 18.94 |
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.
Time frame: Baseline, 12 weeks (post-treatment), 6 months (follow-up)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Web-based CBT (Web-MAP) | Global Health | Baseline | 34.84 score on a scale | Standard Deviation 7.38 |
| Web-based CBT (Web-MAP) | Global Health | Post-Treatment | 36.87 score on a scale | Standard Deviation 8.45 |
| Web-based CBT (Web-MAP) | Global Health | Follow-up | 38.04 score on a scale | Standard Deviation 8.67 |
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.
Time frame: 12 weeks (post-treatment)
Population: Number of treatment modules completed by those completing intervention period
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Web-based CBT (Web-MAP) | Number of Treatment Modules Completed | 0 modules completed | 5 Participants |
| Web-based CBT (Web-MAP) | Number of Treatment Modules Completed | 1-8 modules completed | 72 Participants |
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.
Time frame: 12 weeks (post-treatment)
Population: Teen report of treatment acceptability at post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Web-based CBT (Web-MAP) | Treatment Acceptability | 31.24 score on a scale | Standard Deviation 5.6 |