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Stepped Care for Depression and Musculoskeletal Pain

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ClinicalTrials.gov Identifier: NCT00118430
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : May 9, 2017
Last Update Posted : May 9, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Indiana University

Study Type Interventional
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
Hide 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
[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
Arm/Group Title Stepped Care Usual Care No Treatment Total
Hide 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 127 participants 250 participants 500 participants
Female
69
  56.1%
63
  49.6%
127
  50.8%
259
  51.8%
Male
54
  43.9%
64
  50.4%
123
  49.2%
241
  48.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 127 participants 250 participants 500 participants
American Indian or Alaska Native
2
   1.6%
1
   0.8%
0
   0.0%
3
   0.6%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
42
  34.1%
49
  38.6%
100
  40.0%
191
  38.2%
White
75
  61.0%
76
  59.8%
140
  56.0%
291
  58.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   3.3%
1
   0.8%
10
   4.0%
15
   3.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 123 participants 127 participants 250 participants 500 participants
123 127 250 500
HSCL-20 depression severity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
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)
[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)
Brief Pain Inventory severity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
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)
[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)
Brief Pain Inventory interference   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
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)
[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).
1.Primary Outcome
Title Brief Pain Inventory Interference
Hide 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).
Time Frame Measured at Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stepped Care Usual Care No Treatment
Hide 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
Overall Number of Participants Analyzed 123 127 250
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.0  (2.8) 6.5  (2.4) 4.6  (2.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stepped Care, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments This reported p-value was calculated (and does not merely represent the threshold for significance.
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title HSCL-20 Depression Severity
Hide 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)
Time Frame Measured at Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stepped Care Usual Care No Treatment
Hide 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
Overall Number of Participants Analyzed 123 127 250
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.1  (0.7) 1.7  (0.7) 0.8  (0.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stepped Care, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments This reported p-value was calculated (and does not merely represent the threshold for significance.
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Graded Chronic Pain Scale Disability Score
Hide Description This scale ranges from 0 (no pain-specific disability) to 100 (highest or worst pain-specific disability)
Time Frame Measured at Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stepped Care Usual Care No Treatment
Hide 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
Overall Number of Participants Analyzed 123 127 250
Mean (Standard Deviation)
Unit of Measure: units on a scale
52.5  (31.6) 66.1  (27.3) 44.8  (29.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stepped Care, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Primary Care Visits
Hide Description [Not Specified]
Time Frame Measured at Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Stepped Care Usual Care
Hide 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.

Overall Number of Participants Analyzed 123 127
Mean (Standard Deviation)
Unit of Measure: number of primary care visits
6.3  (5.8) 5.9  (5.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stepped Care, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description The no treatment group did not have depression and was simply followed as a cohort and were not part of the actual clinical trial. Thus, adverse events were not assessed in this group.
 
Arm/Group Title Stepped Care Usual Care
Hide 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.

All-Cause Mortality
Stepped Care Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Stepped Care Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/123 (0.00%)   0/127 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stepped Care Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/123 (0.00%)   0/127 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kurt Kroenke
Organization: Indiana University
Phone: 3172749046
EMail: kkroenke@regenstrief.org
Layout table for additonal information
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