Trial Outcomes & Findings for Stepped Care for Depression and Musculoskeletal Pain (NCT NCT00118430)
NCT ID: NCT00118430
Last Updated: 2017-05-09
Results Overview
The BPI interference scale consists of 7 items, each scored from 0 (no interference) to 10 (complete interference), and the total score is the average of the 7 individual item scores. Therefore, the BPI interference score can range from 0 (lowest pain) to 10 (worst or highest pain).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
500 participants
Primary outcome timeframe
Measured at Year 1
Results posted on
2017-05-09
Participant Flow
Participant milestones
| Measure |
Stepped Care
Stepped care group
Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly with a physician-investigator to review cases, the physician-investigator will be available at all times to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response
Antidepressants: Participants will be assigned to one of the following antidepressant regimens: venlafaxine (37.5 mg, increased to 75, 150, 225 mg
|
Usual Care
Treatment as usual group
Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group.
|
No Treatment
Participants without depression group
|
|---|---|---|---|
|
Overall Study
STARTED
|
123
|
127
|
250
|
|
Overall Study
COMPLETED
|
102
|
103
|
222
|
|
Overall Study
NOT COMPLETED
|
21
|
24
|
28
|
Reasons for withdrawal
| Measure |
Stepped Care
Stepped care group
Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly with a physician-investigator to review cases, the physician-investigator will be available at all times to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response
Antidepressants: Participants will be assigned to one of the following antidepressant regimens: venlafaxine (37.5 mg, increased to 75, 150, 225 mg
|
Usual Care
Treatment as usual group
Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group.
|
No Treatment
Participants without depression group
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
15
|
22
|
28
|
Baseline Characteristics
Stepped Care for Depression and Musculoskeletal Pain
Baseline characteristics by cohort
| Measure |
Stepped Care
n=123 Participants
Stepped care group
Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.
Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline.
|
Usual Care
n=127 Participants
Treatment as usual group
Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group.
|
No Treatment
n=250 Participants
Participants without depression group
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
62.5 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 13.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
259 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
241 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 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
|
42 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
191 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
291 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
123 participants
n=5 Participants
|
127 participants
n=7 Participants
|
250 participants
n=5 Participants
|
500 participants
n=4 Participants
|
|
HSCL-20 depression severity
|
1.8 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
1.9 units on a scale
STANDARD_DEVIATION 0.6 • n=7 Participants
|
0.7 units on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
1.3 units on a scale
STANDARD_DEVIATION 0.8 • n=4 Participants
|
|
Brief Pain Inventory severity
|
6.2 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 1.8 • n=7 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
5.8 units on a scale
STANDARD_DEVIATION 1.8 • n=4 Participants
|
|
Brief Pain Inventory interference
|
6.8 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 2.0 • n=7 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 2.4 • n=4 Participants
|
PRIMARY outcome
Timeframe: Measured at Year 1The BPI interference scale consists of 7 items, each scored from 0 (no interference) to 10 (complete interference), and the total score is the average of the 7 individual item scores. Therefore, the BPI interference score can range from 0 (lowest pain) to 10 (worst or highest pain).
Outcome measures
| Measure |
Stepped Care
n=123 Participants
Stepped care group
Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.
Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline.
|
Usual Care
n=127 Participants
Treatment as usual group
Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group.
|
No Treatment
n=250 Participants
Participants without depression group
|
|---|---|---|---|
|
Brief Pain Inventory Interference
|
5.0 units on a scale
Standard Deviation 2.8
|
6.5 units on a scale
Standard Deviation 2.4
|
4.6 units on a scale
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Measured at Year 1This scale consists of 20 items, each scored from 0 (lowest) to 4 (highest or worst). The scale score is the average of the 20 items. Therefore, the HSCL-20 depression severity score can range from 0 (no depression) to 4 (highest or worst depression)
Outcome measures
| Measure |
Stepped Care
n=123 Participants
Stepped care group
Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.
Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline.
|
Usual Care
n=127 Participants
Treatment as usual group
Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group.
|
No Treatment
n=250 Participants
Participants without depression group
|
|---|---|---|---|
|
HSCL-20 Depression Severity
|
1.1 units on a scale
Standard Deviation 0.7
|
1.7 units on a scale
Standard Deviation 0.7
|
0.8 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Measured at Year 1This scale ranges from 0 (no pain-specific disability) to 100 (highest or worst pain-specific disability)
Outcome measures
| Measure |
Stepped Care
n=123 Participants
Stepped care group
Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.
Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline.
|
Usual Care
n=127 Participants
Treatment as usual group
Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group.
|
No Treatment
n=250 Participants
Participants without depression group
|
|---|---|---|---|
|
Graded Chronic Pain Scale Disability Score
|
52.5 units on a scale
Standard Deviation 31.6
|
66.1 units on a scale
Standard Deviation 27.3
|
44.8 units on a scale
Standard Deviation 29.6
|
SECONDARY outcome
Timeframe: Measured at Year 1Population: The no treatment group did not have depression and was followed simply as a cohort and not part of the clinical trial. Therefore we did not measure this secondary outcome of primary care visits in the no treatment group.
Outcome measures
| Measure |
Stepped Care
n=123 Participants
Stepped care group
Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.
Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline.
|
Usual Care
n=127 Participants
Treatment as usual group
Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group.
|
No Treatment
Participants without depression group
|
|---|---|---|---|
|
Primary Care Visits
|
6.3 number of primary care visits
Standard Deviation 5.8
|
5.9 number of primary care visits
Standard Deviation 5.3
|
—
|
Adverse Events
Stepped Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
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