Trial Outcomes & Findings for Pain Response Evaluation of a Combined Intervention to Cope Effectively (NCT NCT04395001)
NCT ID: NCT04395001
Last Updated: 2025-10-10
Results Overview
BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
280 participants
Primary outcome timeframe
Baseline
Results posted on
2025-10-10
Participant Flow
Participant milestones
| Measure |
Behavioral Intervention, Nurse Support Plus Medication
Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
Nurse-delivered Motivational Interviewing: Subjects randomized to the duloxetine and web-based Cognitive Behavioral Therapy (CBT) with nurse support will receive 6 phone calls from MI trained nurse at week 3, 6, 10, 14, 18 and 22. Telephone sessions may run for 20 minutes on the average.
|
Behavioral Intervention Plus Medication
Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
|
Medication Only
Subjects randomized to this arm will receive duloxetine only.
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
93
|
93
|
94
|
|
Overall Study
COMPLETED
|
75
|
79
|
85
|
|
Overall Study
NOT COMPLETED
|
18
|
14
|
9
|
Reasons for withdrawal
| Measure |
Behavioral Intervention, Nurse Support Plus Medication
Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
Nurse-delivered Motivational Interviewing: Subjects randomized to the duloxetine and web-based Cognitive Behavioral Therapy (CBT) with nurse support will receive 6 phone calls from MI trained nurse at week 3, 6, 10, 14, 18 and 22. Telephone sessions may run for 20 minutes on the average.
|
Behavioral Intervention Plus Medication
Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
|
Medication Only
Subjects randomized to this arm will receive duloxetine only.
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
9
|
5
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
3
|
|
Overall Study
missed appointment
|
7
|
4
|
1
|
Baseline Characteristics
Pain Response Evaluation of a Combined Intervention to Cope Effectively
Baseline characteristics by cohort
| Measure |
Behavioral Intervention, Nurse Support Plus Medication
n=93 Participants
Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
Nurse-delivered Motivational Interviewing: Subjects randomized to the duloxetine and web-based Cognitive Behavioral Therapy (CBT) with nurse support will receive 6 phone calls from MI trained nurse at week 3, 6, 10, 14, 18 and 22. Telephone sessions may run for 20 minutes on the average.
|
Behavioral Intervention Plus Medication
n=93 Participants
Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
|
Medication Only
n=94 Participants
Subjects randomized to this arm will receive duloxetine only.
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
56 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
54 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
55 years
STANDARD_DEVIATION 3.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
189 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
93 participants
n=5 Participants
|
93 participants
n=7 Participants
|
94 participants
n=5 Participants
|
280 participants
n=4 Participants
|
|
Brief Pain Inventory (BPI) total pain severity
|
6.1 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
5.7 units on a scale
STANDARD_DEVIATION 2.1 • n=7 Participants
|
5.8 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 1.8 • n=4 Participants
|
PRIMARY outcome
Timeframe: BaselineBPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Outcome measures
| Measure |
Behavioral Intervention, Nurse Support Plus Medication
n=93 Participants
Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
Nurse-delivered Motivational Interviewing: Subjects randomized to the duloxetine and web-based Cognitive Behavioral Therapy (CBT) with nurse support will receive 6 phone calls from MI trained nurse at week 3, 6, 10, 14, 18 and 22. Telephone sessions may run for 20 minutes on the average.
|
Behavioral Intervention Plus Medication
n=93 Participants
Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
|
Medication Only
n=94 Participants
Subjects randomized to this arm will receive duloxetine only.
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Brief Pain Inventory (BPI) Total Pain Severity
|
6.1 score on a scale
Standard Deviation 1.6
|
5.7 score on a scale
Standard Deviation 2.1
|
5.8 score on a scale
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: week 13 of treatment phaseBPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Outcome measures
| Measure |
Behavioral Intervention, Nurse Support Plus Medication
n=93 Participants
Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
Nurse-delivered Motivational Interviewing: Subjects randomized to the duloxetine and web-based Cognitive Behavioral Therapy (CBT) with nurse support will receive 6 phone calls from MI trained nurse at week 3, 6, 10, 14, 18 and 22. Telephone sessions may run for 20 minutes on the average.
|
Behavioral Intervention Plus Medication
n=93 Participants
Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
|
Medication Only
n=94 Participants
Subjects randomized to this arm will receive duloxetine only.
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Brief Pain Inventory (BPI) Total Pain Severity
|
3.7 score on a scale
Standard Error 0.26
|
3.8 score on a scale
Standard Error .25
|
3.8 score on a scale
Standard Error .25
|
PRIMARY outcome
Timeframe: week 25 of treatment phasePopulation: 18 participants in the intervention/nurse/med group did not complete week 25 visit, 14 participants from the intervention/med group did not complete week 25 visit, 9 participants from the med only group did not complete week 25 visit
BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Outcome measures
| Measure |
Behavioral Intervention, Nurse Support Plus Medication
n=75 Participants
Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
Nurse-delivered Motivational Interviewing: Subjects randomized to the duloxetine and web-based Cognitive Behavioral Therapy (CBT) with nurse support will receive 6 phone calls from MI trained nurse at week 3, 6, 10, 14, 18 and 22. Telephone sessions may run for 20 minutes on the average.
|
Behavioral Intervention Plus Medication
n=79 Participants
Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
|
Medication Only
n=85 Participants
Subjects randomized to this arm will receive duloxetine only.
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Brief Pain Inventory (BPI)
|
3.5 score on a scale
Standard Error .26
|
3.7 score on a scale
Standard Error .25
|
3.6 score on a scale
Standard Error .25
|
SECONDARY outcome
Timeframe: week 25 of treatment phasePopulation: 18 participants in the intervention/nurse/med group did not complete week 25 visit, 14 participants from the intervention/med group did not complete week 25 visit, 9 participants from the med only group did not complete week 25 visit
Adult Self-Reported Measures on physical function. The values of the response to each physical function question will be summed in order to determine the raw score. This must then be converted to the T-score. T-scores are standardized with a mean of 50 and a standard deviation of 10. I.e. a T-score of 40 would be one standard deviation lower than the mean. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Function a T-score of 60 is one standard deviation better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
Outcome measures
| Measure |
Behavioral Intervention, Nurse Support Plus Medication
n=75 Participants
Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
Nurse-delivered Motivational Interviewing: Subjects randomized to the duloxetine and web-based Cognitive Behavioral Therapy (CBT) with nurse support will receive 6 phone calls from MI trained nurse at week 3, 6, 10, 14, 18 and 22. Telephone sessions may run for 20 minutes on the average.
|
Behavioral Intervention Plus Medication
n=79 Participants
Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
|
Medication Only
n=85 Participants
Subjects randomized to this arm will receive duloxetine only.
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
|
39.73 T score
Standard Error 0.82
|
40.2 T score
Standard Error .79
|
41.0 T score
Standard Error 0.77
|
SECONDARY outcome
Timeframe: week 25 of treatment phaseScore is the sum of the 8 items. Score ranges from 0-24. A score of 10 or greater is considered major depression, 20 or more is severe major depression.
Outcome measures
| Measure |
Behavioral Intervention, Nurse Support Plus Medication
n=93 Participants
Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
Nurse-delivered Motivational Interviewing: Subjects randomized to the duloxetine and web-based Cognitive Behavioral Therapy (CBT) with nurse support will receive 6 phone calls from MI trained nurse at week 3, 6, 10, 14, 18 and 22. Telephone sessions may run for 20 minutes on the average.
|
Behavioral Intervention Plus Medication
n=93 Participants
Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
|
Medication Only
n=94 Participants
Subjects randomized to this arm will receive duloxetine only.
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Patient Health Questionnaire 8-Item Depression Scale (PHQ-8)
|
5.7 score on a scale
Standard Error 0.52
|
6.6 score on a scale
Standard Error 0.5
|
6.1 score on a scale
Standard Error 0.49
|
SECONDARY outcome
Timeframe: week 25 of treatment phasePopulation: 18 participants in the intervention/nurse/med group did not complete week 25 visit, 14 participants from the intervention/med group did not complete week 25 visit, 9 participants from the med only group did not complete week 25 visit
Score ranges from 0-24. Scores of 5, 10, and 15 are the respective cut-offs for mild, moderate, and severe anxiety. Further evaluation is recommended when a score of 10 or greater is recorded.
Outcome measures
| Measure |
Behavioral Intervention, Nurse Support Plus Medication
n=75 Participants
Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
Nurse-delivered Motivational Interviewing: Subjects randomized to the duloxetine and web-based Cognitive Behavioral Therapy (CBT) with nurse support will receive 6 phone calls from MI trained nurse at week 3, 6, 10, 14, 18 and 22. Telephone sessions may run for 20 minutes on the average.
|
Behavioral Intervention Plus Medication
n=79 Participants
Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
|
Medication Only
n=85 Participants
Subjects randomized to this arm will receive duloxetine only.
duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Generalized Anxiety Disorder 7-item Scale (GAD-7)
|
3.8 score on a scale
Standard Error 0.41
|
3.7 score on a scale
Standard Error 0.4
|
4.0 score on a scale
Standard Error 0.39
|
Adverse Events
Behavioral Intervention, Nurse Support Plus Medication
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Behavioral Intervention Plus Medication
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Medication Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place