Trial Outcomes & Findings for Tailored Non-Pharmacotherapy Services for Chronic Pain (NCT NCT04523714)
NCT ID: NCT04523714
Last Updated: 2026-01-22
Results Overview
Minimal clinically important difference (MCID) in pain severity is defined as a 30% or greater improvement in pain severity score. \[Pain severity score assessed via modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF) from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.\] MCID outcome is binary; reported as the adjusted percentage of participants with MCID (\> or =30% improvement) in pain severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2333 participants
Primary outcome timeframe
Baseline to 3 months
Results posted on
2026-01-22
Participant Flow
Participant milestones
| Measure |
Online CBT-CP Based Program
Self-completed, online cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Health Coach-led CBT-CP Based Program
Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Usual Care Plus Information
Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction
|
|---|---|---|---|
|
Overall Study
STARTED
|
776
|
778
|
779
|
|
Overall Study
COMPLETED
|
730
|
726
|
754
|
|
Overall Study
NOT COMPLETED
|
46
|
52
|
25
|
Reasons for withdrawal
| Measure |
Online CBT-CP Based Program
Self-completed, online cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Health Coach-led CBT-CP Based Program
Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Usual Care Plus Information
Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction
|
|---|---|---|---|
|
Overall Study
Death
|
3
|
7
|
7
|
|
Overall Study
Withdrawal by Subject
|
43
|
45
|
16
|
|
Overall Study
Randomized in error
|
0
|
0
|
2
|
Baseline Characteristics
Tailored Non-Pharmacotherapy Services for Chronic Pain
Baseline characteristics by cohort
| Measure |
Online CBT-CP Based Program
n=776 Participants
Self-completed, online cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Health Coach-led CBT-CP Based Program
n=778 Participants
Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Usual Care Plus Information
n=777 Participants
Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction
|
Total
n=2331 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 13.9 • n=270 Participants
|
58.8 years
STANDARD_DEVIATION 14.5 • n=4 Participants
|
58.8 years
STANDARD_DEVIATION 14.3 • n=9 Participants
|
58.8 years
STANDARD_DEVIATION 14.3 • n=220 Participants
|
|
Age, Customized
Age 65 years and older
|
291 Participants
n=270 Participants
|
305 Participants
n=4 Participants
|
304 Participants
n=9 Participants
|
900 Participants
n=220 Participants
|
|
Sex: Female, Male
Female
|
571 Participants
n=270 Participants
|
572 Participants
n=4 Participants
|
570 Participants
n=9 Participants
|
1713 Participants
n=220 Participants
|
|
Sex: Female, Male
Male
|
205 Participants
n=270 Participants
|
206 Participants
n=4 Participants
|
207 Participants
n=9 Participants
|
618 Participants
n=220 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity : White Non-Hispanic
|
573 Participants
n=270 Participants
|
572 Participants
n=4 Participants
|
554 Participants
n=9 Participants
|
1699 Participants
n=220 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity : Black or African American Non-Hispanic
|
119 Participants
n=270 Participants
|
118 Participants
n=4 Participants
|
113 Participants
n=9 Participants
|
350 Participants
n=220 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity : Hispanic
|
21 Participants
n=270 Participants
|
26 Participants
n=4 Participants
|
30 Participants
n=9 Participants
|
77 Participants
n=220 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity : Asian
|
10 Participants
n=270 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=9 Participants
|
27 Participants
n=220 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity : American Indian / Alaska Native
|
6 Participants
n=270 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=9 Participants
|
28 Participants
n=220 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity : Native Hawaiian / Other Pacific Islander
|
1 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=220 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity : More than one race
|
21 Participants
n=270 Participants
|
27 Participants
n=4 Participants
|
35 Participants
n=9 Participants
|
83 Participants
n=220 Participants
|
|
Race/Ethnicity, Customized
Missing
|
25 Participants
n=270 Participants
|
18 Participants
n=4 Participants
|
22 Participants
n=9 Participants
|
65 Participants
n=220 Participants
|
|
Region of Enrollment
United States
|
776 participants
n=270 Participants
|
778 participants
n=4 Participants
|
777 participants
n=9 Participants
|
2331 participants
n=220 Participants
|
|
Rural/medically underserved residency
|
340 Participants
n=270 Participants
|
345 Participants
n=4 Participants
|
345 Participants
n=9 Participants
|
1030 Participants
n=220 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3 monthsMinimal clinically important difference (MCID) in pain severity is defined as a 30% or greater improvement in pain severity score. \[Pain severity score assessed via modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF) from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.\] MCID outcome is binary; reported as the adjusted percentage of participants with MCID (\> or =30% improvement) in pain severity.
Outcome measures
| Measure |
Online CBT-CP Based Program
n=776 Participants
Self-completed, online cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Health Coach-led CBT-CP Based Program
n=778 Participants
Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Usual Care Plus Information
n=777 Participants
Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction
|
|---|---|---|---|
|
Minimal Clinically Important Difference (MCID) in Pain Severity at 3 Months (Yes / No)
|
26.6 Adjusted percentage of participants
Interval 23.4 to 30.2
|
32.0 Adjusted percentage of participants
Interval 29.3 to 35.0
|
20.8 Adjusted percentage of participants
Interval 18.0 to 24.0
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsMinimal clinically important difference (MCID) in pain severity is defined as a 30% decrease in score on modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF) from baseline (consistent with IMMPACT guidelines) (binary) Minimal clinically important difference (MCID) in pain severity is defined as a 30% or greater improvement in pain severity score. \[Pain severity score assessed via modified 11-item version of the BPI-SF from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.\] MCID outcome is binary; reported as the adjusted percentage of participants with MCID (\> or =30% improvement) in pain severity.
Outcome measures
| Measure |
Online CBT-CP Based Program
n=776 Participants
Self-completed, online cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Health Coach-led CBT-CP Based Program
n=778 Participants
Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Usual Care Plus Information
n=777 Participants
Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction
|
|---|---|---|---|
|
MCID in Pain Severity at 6 Months (Yes / No)
|
32.9 Adjusted percentage of participants
Interval 29.5 to 36.7
|
37.1 Adjusted percentage of participants
Interval 34.1 to 40.5
|
22.9 Adjusted percentage of participants
Interval 20.0 to 26.1
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsMinimal clinically important difference (MCID) in pain severity is defined as a 30% or greater improvement in pain severity score. \[Pain severity score assessed via modified 11-item version of the BPI-SF from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.\] MCID outcome is binary; reported as the adjusted percentage of participants with MCID (\> or =30% improvement) in pain severity.
Outcome measures
| Measure |
Online CBT-CP Based Program
n=776 Participants
Self-completed, online cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Health Coach-led CBT-CP Based Program
n=778 Participants
Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Usual Care Plus Information
n=777 Participants
Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction
|
|---|---|---|---|
|
MCID in Pain Severity at 12 Months (Yes / No)
|
35.9 Adjusted percentage of participants
Interval 32.4 to 39.7
|
38.3 Adjusted percentage of participants
Interval 36.8 to 39.9
|
27.1 Adjusted percentage of participants
Interval 24.1 to 30.5
|
SECONDARY outcome
Timeframe: Baseline to 3, 6 and 12 monthsModified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF). Score is calculated mean of all 11 items; range 0-10 with a higher score = worse pain severity
Outcome measures
| Measure |
Online CBT-CP Based Program
n=643 Participants
Self-completed, online cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Health Coach-led CBT-CP Based Program
n=690 Participants
Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Usual Care Plus Information
n=703 Participants
Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction
|
|---|---|---|---|
|
Pain Severity Score
3 months
|
-1.2 Adjusted mean change (score on a scale)
Interval -1.3 to -1.0
|
-1.2 Adjusted mean change (score on a scale)
Interval -1.3 to -1.1
|
-0.8 Adjusted mean change (score on a scale)
Interval -0.9 to -0.6
|
|
Pain Severity Score
6 months
|
-1.3 Adjusted mean change (score on a scale)
Interval -1.4 to -1.1
|
-1.4 Adjusted mean change (score on a scale)
Interval -1.5 to -1.3
|
-0.9 Adjusted mean change (score on a scale)
Interval -1.0 to -0.8
|
|
Pain Severity Score
12 months
|
-1.5 Adjusted mean change (score on a scale)
Interval -1.6 to -1.3
|
-1.4 Adjusted mean change (score on a scale)
Interval -1.6 to -1.3
|
-1.1 Adjusted mean change (score on a scale)
Interval -1.2 to -0.9
|
SECONDARY outcome
Timeframe: Baseline to 3, 6, and 12 months4-item subscale of the Brief Pain Inventory - Short Form (BPI-SF). Score is calculated mean of all 4 items; range 0-10 with a higher score = worse pain intensity
Outcome measures
| Measure |
Online CBT-CP Based Program
n=643 Participants
Self-completed, online cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Health Coach-led CBT-CP Based Program
n=690 Participants
Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Usual Care Plus Information
n=703 Participants
Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction
|
|---|---|---|---|
|
Pain Intensity Score
3 months
|
-0.9 Adjusted mean change (score on a scale)
Interval -1.0 to -0.8
|
-0.9 Adjusted mean change (score on a scale)
Interval -1.0 to -0.8
|
-0.6 Adjusted mean change (score on a scale)
Interval -0.7 to -0.5
|
|
Pain Intensity Score
6 months
|
-1.0 Adjusted mean change (score on a scale)
Interval -1.1 to -0.9
|
-1.1 Adjusted mean change (score on a scale)
Interval -1.2 to -1.0
|
-0.7 Adjusted mean change (score on a scale)
Interval -0.9 to -0.6
|
|
Pain Intensity Score
12 months
|
-1.1 Adjusted mean change (score on a scale)
Interval -1.3 to -1.0
|
-1.1 Adjusted mean change (score on a scale)
Interval -1.3 to -1.0
|
-0.9 Adjusted mean change (score on a scale)
Interval -1.0 to -0.8
|
SECONDARY outcome
Timeframe: Baseline to 3, 6 and 12 months7-item subscale of the Brief Pain Inventory - Short Form (BPI-SF). Score is calculated mean of 7 items; range 0-10 with a higher score = worse pain-related interference
Outcome measures
| Measure |
Online CBT-CP Based Program
n=643 Participants
Self-completed, online cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Health Coach-led CBT-CP Based Program
n=690 Participants
Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Usual Care Plus Information
n=703 Participants
Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction
|
|---|---|---|---|
|
Pain-related Interference Score
3 months
|
-1.3 Adjusted mean change (score on a scale)
Interval -1.4 to -1.1
|
-1.4 Adjusted mean change (score on a scale)
Interval -1.5 to -1.2
|
-0.8 Adjusted mean change (score on a scale)
Interval -1.0 to -0.7
|
|
Pain-related Interference Score
6 months
|
-1.5 Adjusted mean change (score on a scale)
Interval -1.6 to -1.3
|
-1.6 Adjusted mean change (score on a scale)
Interval -1.8 to -1.4
|
-1.0 Adjusted mean change (score on a scale)
Interval -1.1 to -0.8
|
|
Pain-related Interference Score
12 months
|
-1.6 Adjusted mean change (score on a scale)
Interval -1.8 to -1.5
|
-1.6 Adjusted mean change (score on a scale)
Interval -1.8 to -1.5
|
-1.2 Adjusted mean change (score on a scale)
Interval -1.3 to -1.0
|
SECONDARY outcome
Timeframe: Baseline to 3, 6 and 12 monthsPROMIS Ability to Participate in Social Roles and Activities - Short Form 4a: Score by summing the 4 items (each item response 1-5) and then converting raw score to standardized T-score, using the HealthMeasures Scoring Service, with mean of 50 and standard deviation of 10. Higher T-score= better ability to participate in social roles and activities. Score ≤40 indicates moderate (40-30) to severe (\< 30) limitations in ability to participate.
Outcome measures
| Measure |
Online CBT-CP Based Program
n=636 Participants
Self-completed, online cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Health Coach-led CBT-CP Based Program
n=683 Participants
Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Usual Care Plus Information
n=696 Participants
Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction
|
|---|---|---|---|
|
Social Role Functioning
3 months
|
1.5 Adjusted mean change (score on a scale)
Interval 1.0 to 2.1
|
2.2 Adjusted mean change (score on a scale)
Interval 1.7 to 2.7
|
0.7 Adjusted mean change (score on a scale)
Interval 0.3 to 1.2
|
|
Social Role Functioning
6 months
|
2.2 Adjusted mean change (score on a scale)
Interval 1.6 to 2.8
|
2.5 Adjusted mean change (score on a scale)
Interval 2.0 to 3.1
|
1.0 Adjusted mean change (score on a scale)
Interval 0.5 to 1.5
|
|
Social Role Functioning
12 months
|
2.6 Adjusted mean change (score on a scale)
Interval 2.0 to 3.2
|
2.7 Adjusted mean change (score on a scale)
Interval 2.2 to 3.3
|
1.4 Adjusted mean change (score on a scale)
Interval 0.8 to 1.9
|
SECONDARY outcome
Timeframe: Baseline to 3, 6 and 12 monthsPROMIS Physical Function - Short Form 6b: Score by summing the 6 items (each item response 1-5) and then converting raw score to standardized T-score, using the HealthMeasures Scoring Service, with mean of 50 and standard deviation of 10. Higher T-score= better physical functioning. Score ≤40 indicates moderate (40-30) to severe (\< 30) limitations in physical functioning.
Outcome measures
| Measure |
Online CBT-CP Based Program
n=639 Participants
Self-completed, online cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Health Coach-led CBT-CP Based Program
n=684 Participants
Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Usual Care Plus Information
n=699 Participants
Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction
|
|---|---|---|---|
|
Physical Functioning
3 months
|
1.4 Adjusted mean change (score on a scale)
Interval 1.1 to 1.8
|
1.7 Adjusted mean change (score on a scale)
Interval 1.4 to 2.1
|
1.0 Adjusted mean change (score on a scale)
Interval 0.7 to 1.4
|
|
Physical Functioning
6 months
|
2.0 Adjusted mean change (score on a scale)
Interval 1.6 to 2.4
|
1.8 Adjusted mean change (score on a scale)
Interval 1.4 to 2.1
|
1.4 Adjusted mean change (score on a scale)
Interval 1.0 to 1.7
|
|
Physical Functioning
12 months
|
2.2 Adjusted mean change (score on a scale)
Interval 1.8 to 2.7
|
2.1 Adjusted mean change (score on a scale)
Interval 1.7 to 2.5
|
1.3 Adjusted mean change (score on a scale)
Interval 0.9 to 1.7
|
SECONDARY outcome
Timeframe: Primary: Baseline to 3, 6 and 12 monthsOne item assessing participant's perception of change in pain since start of study; range 1-7 (1=much better, 2=moderately better, 3=a little better, 4=No change, 5=a little worse, 6=moderately worse, 7=much worse). Higher score = worsening of pain
Outcome measures
| Measure |
Online CBT-CP Based Program
n=640 Participants
Self-completed, online cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Health Coach-led CBT-CP Based Program
n=687 Participants
Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Usual Care Plus Information
n=702 Participants
Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction
|
|---|---|---|---|
|
Patient Global Impression of Change (PGIC) - Pain
3 months
|
2.2 Adjusted mean (score on a scale)
Interval 2.1 to 2.3
|
2.0 Adjusted mean (score on a scale)
Interval 1.9 to 2.1
|
2.9 Adjusted mean (score on a scale)
Interval 2.8 to 3.0
|
|
Patient Global Impression of Change (PGIC) - Pain
6 months
|
2.2 Adjusted mean (score on a scale)
Interval 2.1 to 2.3
|
2.1 Adjusted mean (score on a scale)
Interval 2.0 to 2.2
|
2.8 Adjusted mean (score on a scale)
Interval 2.7 to 2.9
|
|
Patient Global Impression of Change (PGIC) - Pain
12 months
|
2.2 Adjusted mean (score on a scale)
Interval 2.1 to 2.3
|
2.2 Adjusted mean (score on a scale)
Interval 2.1 to 2.4
|
2.8 Adjusted mean (score on a scale)
Interval 2.7 to 2.9
|
SECONDARY outcome
Timeframe: Baseline to 3, 6 and 12 monthsOne item assessing participant's perception of change in overall status since start of study; range 1-7 (1=much better, 2=moderately better, 3=a little better, 4=No change, 5=a little worse, 6=moderately worse, 7=much worse). Higher score = worsening of overall status
Outcome measures
| Measure |
Online CBT-CP Based Program
n=640 Participants
Self-completed, online cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Health Coach-led CBT-CP Based Program
n=687 Participants
Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Usual Care Plus Information
n=702 Participants
Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction
|
|---|---|---|---|
|
Patient Global Impression of Change (PGIC) - General
12 months
|
2.0 Adjusted mean (score on a scale)
Interval 1.9 to 2.1
|
1.9 Adjusted mean (score on a scale)
Interval 1.8 to 2.0
|
2.6 Adjusted mean (score on a scale)
Interval 2.5 to 2.7
|
|
Patient Global Impression of Change (PGIC) - General
3 months
|
2.0 Adjusted mean (score on a scale)
Interval 1.9 to 2.1
|
1.6 Adjusted mean (score on a scale)
Interval 1.5 to 1.7
|
2.7 Adjusted mean (score on a scale)
Interval 2.6 to 2.8
|
|
Patient Global Impression of Change (PGIC) - General
6 months
|
2.1 Adjusted mean (score on a scale)
Interval 2.0 to 2.2
|
1.8 Adjusted mean (score on a scale)
Interval 1.7 to 1.9
|
2.5 Adjusted mean (score on a scale)
Interval 2.5 to 2.6
|
Adverse Events
Online CBT-CP Based Program
Serious events: 55 serious events
Other events: 1 other events
Deaths: 3 deaths
Health Coach-led CBT-CP Based Program
Serious events: 65 serious events
Other events: 16 other events
Deaths: 7 deaths
Usual Care Plus Information
Serious events: 63 serious events
Other events: 0 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Online CBT-CP Based Program
n=776 participants at risk
Self-completed, online cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Health Coach-led CBT-CP Based Program
n=778 participants at risk
Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Usual Care Plus Information
n=777 participants at risk
Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction
|
|---|---|---|---|
|
General disorders
Hospitalizations
|
7.1%
55/776 • Number of events 81 • 12-month study participation period
Severe Adverse Events, including death and hospitalizations, were systematically monitored. Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. These events were monitored for the 2,331 eligible randomized participants. The 2 individuals who were randomized in error (i.e., totaling 2,333 in the Participant Flow) were not monitored for these events as they were withdrawn immediately after randomization when the error was identified.
|
8.4%
65/778 • Number of events 84 • 12-month study participation period
Severe Adverse Events, including death and hospitalizations, were systematically monitored. Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. These events were monitored for the 2,331 eligible randomized participants. The 2 individuals who were randomized in error (i.e., totaling 2,333 in the Participant Flow) were not monitored for these events as they were withdrawn immediately after randomization when the error was identified.
|
8.1%
63/777 • Number of events 82 • 12-month study participation period
Severe Adverse Events, including death and hospitalizations, were systematically monitored. Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. These events were monitored for the 2,331 eligible randomized participants. The 2 individuals who were randomized in error (i.e., totaling 2,333 in the Participant Flow) were not monitored for these events as they were withdrawn immediately after randomization when the error was identified.
|
Other adverse events
| Measure |
Online CBT-CP Based Program
n=776 participants at risk
Self-completed, online cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Health Coach-led CBT-CP Based Program
n=778 participants at risk
Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted)
|
Usual Care Plus Information
n=777 participants at risk
Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction
|
|---|---|---|---|
|
General disorders
Participant-reported adverse event
|
0.13%
1/776 • Number of events 1 • 12-month study participation period
Severe Adverse Events, including death and hospitalizations, were systematically monitored. Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. These events were monitored for the 2,331 eligible randomized participants. The 2 individuals who were randomized in error (i.e., totaling 2,333 in the Participant Flow) were not monitored for these events as they were withdrawn immediately after randomization when the error was identified.
|
2.1%
16/778 • Number of events 16 • 12-month study participation period
Severe Adverse Events, including death and hospitalizations, were systematically monitored. Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. These events were monitored for the 2,331 eligible randomized participants. The 2 individuals who were randomized in error (i.e., totaling 2,333 in the Participant Flow) were not monitored for these events as they were withdrawn immediately after randomization when the error was identified.
|
0.00%
0/777 • 12-month study participation period
Severe Adverse Events, including death and hospitalizations, were systematically monitored. Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. These events were monitored for the 2,331 eligible randomized participants. The 2 individuals who were randomized in error (i.e., totaling 2,333 in the Participant Flow) were not monitored for these events as they were withdrawn immediately after randomization when the error was identified.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place