Trial Outcomes & Findings for Mechanisms Of Change in Adolescent Pain Self-management (NCT NCT04043962)
NCT ID: NCT04043962
Last Updated: 2022-10-18
Results Overview
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.
COMPLETED
NA
85 participants
Baseline, 12 weeks (post-treatment), 6 months (follow-up)
2022-10-18
Participant Flow
Participant gave consent for did not complete the pre-treatment assessment
Participant milestones
| Measure |
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
|
|---|---|
|
Baseline
STARTED
|
85
|
|
Baseline
COMPLETED
|
85
|
|
Baseline
NOT COMPLETED
|
0
|
|
Post-Treatment
STARTED
|
85
|
|
Post-Treatment
COMPLETED
|
77
|
|
Post-Treatment
NOT COMPLETED
|
8
|
|
Follow-up
STARTED
|
80
|
|
Follow-up
COMPLETED
|
73
|
|
Follow-up
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Post-Treatment
Declined due to lack of time/interest or could not be reached
|
3
|
|
Post-Treatment
Withdrawal by Subject
|
5
|
|
Follow-up
Declined due to lack of time/interest or could not be reached
|
7
|
Baseline Characteristics
Mechanisms Of Change in Adolescent Pain Self-management
Baseline characteristics by cohort
| Measure |
Web-based CBT (Web-MAP)
n=85 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
85 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
15.5 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Parent education
High school or less
|
4 Participants
n=5 Participants
|
|
Parent education
College or vocational school
|
60 Participants
n=5 Participants
|
|
Parent education
Graduate or professional school
|
20 Participants
n=5 Participants
|
|
Parent education
Not reported
|
1 Participants
n=5 Participants
|
|
Annual household income
$49,999 or less
|
24 Participants
n=5 Participants
|
|
Annual household income
$50,000 - $99,999
|
25 Participants
n=5 Participants
|
|
Annual household income
$100,000 or more
|
35 Participants
n=5 Participants
|
|
Annual household income
Not reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Web-based CBT (Web-MAP)
n=85 Participants
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
|
|---|---|
|
Pain Intensity Ratings
Baseline
|
5.86 score on a scale
Standard Deviation 1.66
|
|
Pain Intensity Ratings
Post-Treatment
|
5.64 score on a scale
Standard Deviation 1.54
|
|
Pain Intensity Ratings
Follow-up
|
5.45 score on a scale
Standard Deviation 1.66
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Web-based CBT (Web-MAP)
n=85 Participants
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
|
|---|---|
|
Pain-related Disability
Baseline
|
48.33 score on a scale
Standard Deviation 21.84
|
|
Pain-related Disability
Post-Treatment
|
44.48 score on a scale
Standard Deviation 22.52
|
|
Pain-related Disability
Follow-up
|
44.45 score on a scale
Standard Deviation 23.40
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Web-based CBT (Web-MAP)
n=85 Participants
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
|
|---|---|
|
Fatigue
Baseline
|
44.58 score on a scale
Standard Deviation 18.24
|
|
Fatigue
Post-Treatment
|
48.71 score on a scale
Standard Deviation 15.70
|
|
Fatigue
Follow-up
|
47.79 score on a scale
Standard Deviation 18.94
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Web-based CBT (Web-MAP)
n=85 Participants
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
|
|---|---|
|
Global Health
Baseline
|
34.84 score on a scale
Standard Deviation 7.38
|
|
Global Health
Post-Treatment
|
36.87 score on a scale
Standard Deviation 8.45
|
|
Global Health
Follow-up
|
38.04 score on a scale
Standard Deviation 8.67
|
SECONDARY outcome
Timeframe: 12 weeks (post-treatment)Population: Number of treatment modules completed by those completing intervention period
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.
Outcome measures
| Measure |
Web-based CBT (Web-MAP)
n=77 Participants
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
|
|---|---|
|
Number of Treatment Modules Completed
0 modules completed
|
5 Participants
|
|
Number of Treatment Modules Completed
1-8 modules completed
|
72 Participants
|
SECONDARY outcome
Timeframe: 12 weeks (post-treatment)Population: Teen report of treatment acceptability at 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.
Outcome measures
| Measure |
Web-based CBT (Web-MAP)
n=77 Participants
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
|
|---|---|
|
Treatment Acceptability
|
31.24 score on a scale
Standard Deviation 5.60
|
Adverse Events
Web-based CBT (Web-MAP)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tonya Palermo, Professor, Anesthesiology and Pain Medicine, Seattle Children's Hospital
Seattle Children's Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place