Stepped Care for Depression and Musculoskeletal Pain
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| ClinicalTrials.gov Identifier: NCT00118430 |
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Recruitment Status :
Completed
First Posted : July 11, 2005
Results First Posted : May 9, 2017
Last Update Posted : May 9, 2017
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| Study Type | Interventional |
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| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Conditions |
Pain Depression |
| Interventions |
Behavioral: Stepped Care Drug: Antidepressants Drug: Usual Care |
| Enrollment | 500 |
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Stepped Care | Usual Care | No Treatment |
|---|---|---|---|
 Arm/Group Description |
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 |
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. |
Participants without depression group |
| Period Title: Overall Study | |||
| Started | 123 | 127 | 250 |
| Completed | 102 [1] | 103 [2] | 222 |
| Not Completed | 21 | 24 | 28 |
| Reason Not Completed | |||
| Withdrawal by Subject | 6 | 2 | 0 |
| Lost to Follow-up | 15 | 22 | 28 |
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[1]
123 included in primary analysis due to repeated measures and interim 1,3 and 6 month assessments
[2]
127 included in primary analysis due to repeated measures and interim 1,3 and 6 month assessments
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| Arm/Group Title | Stepped Care | Usual Care | No Treatment | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
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. |
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. |
Participants without depression group | Total of all reporting groups | |
| Overall Number of Baseline Participants | 123 | 127 | 250 | 500 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 123 participants | 127 participants | 250 participants | 500 participants | |
| 55.2 (12.6) | 55.8 (11.1) | 62.5 (14.1) | 59.0 (13.4) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 123 participants | 127 participants | 250 participants | 500 participants | |
| Female |
69 56.1%
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63 49.6%
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127 50.8%
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259 51.8%
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| Male |
54 43.9%
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64 50.4%
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123 49.2%
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241 48.2%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 123 participants | 127 participants | 250 participants | 500 participants | |
| American Indian or Alaska Native |
2 1.6%
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1 0.8%
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0 0.0%
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3 0.6%
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| Asian |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
42 34.1%
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49 38.6%
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100 40.0%
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191 38.2%
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| White |
75 61.0%
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76 59.8%
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140 56.0%
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291 58.2%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
4 3.3%
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1 0.8%
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10 4.0%
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15 3.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 123 participants | 127 participants | 250 participants | 500 participants |
| 123 | 127 | 250 | 500 | ||
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HSCL-20 depression severity
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 123 participants | 127 participants | 250 participants | 500 participants | |
| 1.8 (0.7) | 1.9 (0.6) | 0.7 (0.5) | 1.3 (0.8) | ||
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[1]
Measure Description: This 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)
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Brief Pain Inventory severity
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 123 participants | 127 participants | 250 participants | 500 participants | |
| 6.2 (1.8) | 6.1 (1.8) | 5.4 (1.8) | 5.8 (1.8) | ||
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[1]
Measure Description: The BPI severity scale is a 4-item scale with each item scored from 0 (no pain) to 10 (worst pain imaginable). The scale score is the average of the 4 items and thus can range from 0 (no pain) to 10 (worst or more severe pain)
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Brief Pain Inventory interference
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 123 participants | 127 participants | 250 participants | 500 participants | |
| 6.8 (2.2) | 7.1 (2.0) | 4.8 (2.2) | 5.9 (2.4) | ||
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[1]
Measure Description: 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).
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| Name/Title: | Kurt Kroenke |
| Organization: | Indiana University |
| Phone: | 3172749046 |
| EMail: | kkroenke@regenstrief.org |
| Responsible Party: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00118430 |
| Other Study ID Numbers: |
R01MH071268 ( U.S. NIH Grant/Contract ) R01MH071268 ( U.S. NIH Grant/Contract ) |
| First Submitted: | July 6, 2005 |
| First Posted: | July 11, 2005 |
| Results First Submitted: | May 23, 2016 |
| Results First Posted: | May 9, 2017 |
| Last Update Posted: | May 9, 2017 |