Pain, Depression
Conditions
Keywords
Back Pain, Knee Pain, Hip Pain, Stepped Care, Antidepressant, Relaxation Techniques, Exercise
Brief summary
This study will evaluate the effectiveness of a stepped care approach in treating depression and reducing pain.
Detailed description
In the United States, pain accounts for nearly 20% of all primary health care visits. In the majority of cases, the pain is musculoskeletal and primarily affects the lower back, hips, and knees. Studies have shown that at least one-third of patients with pain also suffer from depression. It has not been determined whether treatments for depression are effective in patients with comorbid pain and depression. The Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) study will determine the most effective treatment for patients with pain and depression. This study will last 12 months and will comprise depressed and nondepressed participants. Nondepressed participants will receive no treatment. Depressed patients will be randomly assigned to receive standard of care or stepped care for 12 weeks. Standard of care may include cognitive therapy, antidepressant treatment, or other treatments. The stepped care group will receive 12 weeks of antidepressant treatment. Participants who respond to antidepressant treatment will continue their treatment for the duration of the study. Participants who do not respond to the treatment after 12 weeks will receive 6 weekly pain self-management sessions. During these sessions, an educator will teach participants how to manage their pain through exercise and relaxation techniques. Self-report scales and questionnaires will be used to assess participants' pain, depressive symptoms, health care usage and costs, and quality of life. Depressed participants will undergo assessments at study start and at Months 1, 3, 6, and 12. Nondepressed participants will undergo assessments at study start and at Months 3 and 12. Study hypotheses: 1) Stepped care is more effective than usual care in improving depression and pain. 2) Stepped care is more effective than usual care in improving health-related quality of life, negative pain beliefs and behaviors, reduced opiate use, and health care costs. 3) Patients with musculoskeletal pain who are not depressed at baseline will have an incidence of depression less than 20% over 12 months of follow-up, characteristics that can be identified as risk factors for incident depression, baseline characteristics distinguishing them from depressed patients, and better pain and health status outcomes, compared to depressed patients.
Interventions
BEHAVIORALStepped 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.
DRUGAntidepressants
Participants will be assigned to one of the following antidepressant regimens: venlafaxine (37.5 mg, increased to 75, 150, 225 mg); duloxetine (60 mg, increased to 120 mg); fluoxetine (20 mg, increased to 30 to 40 mg); sertraline (50 mg, increased to 100 to 150 mg); citalopram (20 mg, increased to 30 to 40 mg); paroxetine (20 mg, increased to 30 to 40 mg); or nortriptyline (25 mg, increased to 50 to 75 mg).
DRUGUsual Care
This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group.
Sponsors
National Institute of Mental Health (NIMH)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Moderate or severe pain in the back, hips, or knees for at least 3 months prior to study entry * History of or current use of at least one medication for pain * English-speaking
Exclusion criteria
* Moderate to severe cognitive impairment * Schizophrenia or other psychotic disorders * Receiving disability benefits for pain * Anticipated life expectancy less than 12 months * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory Interference | Measured at Year 1 | 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). |
| HSCL-20 Depression Severity | Measured at Year 1 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graded Chronic Pain Scale Disability Score | Measured at Year 1 | This scale ranges from 0 (no pain-specific disability) to 100 (highest or worst pain-specific disability) |
| Primary Care Visits | Measured at Year 1 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 123 |
| 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. | 127 |
| No Treatment Participants without depression group | 250 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 15 | 22 | 28 |
| Overall Study | Withdrawal by Subject | 6 | 2 | 0 |
Baseline characteristics
| Characteristic | Usual Care | Total | Stepped Care | No Treatment |
|---|---|---|---|---|
| Age, Continuous | 55.8 years STANDARD_DEVIATION 11.1 | 59.0 years STANDARD_DEVIATION 13.4 | 55.2 years STANDARD_DEVIATION 12.6 | 62.5 years STANDARD_DEVIATION 14.1 |
| Brief Pain Inventory interference | 7.1 units on a scale STANDARD_DEVIATION 2 | 5.9 units on a scale STANDARD_DEVIATION 2.4 | 6.8 units on a scale STANDARD_DEVIATION 2.2 | 4.8 units on a scale STANDARD_DEVIATION 2.2 |
| Brief Pain Inventory severity | 6.1 units on a scale STANDARD_DEVIATION 1.8 | 5.8 units on a scale STANDARD_DEVIATION 1.8 | 6.2 units on a scale STANDARD_DEVIATION 1.8 | 5.4 units on a scale STANDARD_DEVIATION 1.8 |
| HSCL-20 depression severity | 1.9 units on a scale STANDARD_DEVIATION 0.6 | 1.3 units on a scale STANDARD_DEVIATION 0.8 | 1.8 units on a scale STANDARD_DEVIATION 0.7 | 0.7 units on a scale STANDARD_DEVIATION 0.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 49 Participants | 191 Participants | 42 Participants | 100 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 15 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) White | 76 Participants | 291 Participants | 75 Participants | 140 Participants |
| Region of Enrollment United States | 127 participants | 500 participants | 123 participants | 250 participants |
| Sex: Female, Male Female | 63 Participants | 259 Participants | 69 Participants | 127 Participants |
| Sex: Female, Male Male | 64 Participants | 241 Participants | 54 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 123 | 0 / 127 |
| serious Total, serious adverse events | 0 / 123 | 0 / 127 |
Outcome results
Primary
Brief Pain Inventory Interference
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care | Brief Pain Inventory Interference | 5.0 units on a scale | Standard Deviation 2.8 |
| Usual Care | Brief Pain Inventory Interference | 6.5 units on a scale | Standard Deviation 2.4 |
| No Treatment | Brief Pain Inventory Interference | 4.6 units on a scale | Standard Deviation 2.4 |
p-value: <0.001Mixed Models Analysis
Primary
HSCL-20 Depression Severity
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care | HSCL-20 Depression Severity | 1.1 units on a scale | Standard Deviation 0.7 |
| Usual Care | HSCL-20 Depression Severity | 1.7 units on a scale | Standard Deviation 0.7 |
| No Treatment | HSCL-20 Depression Severity | 0.8 units on a scale | Standard Deviation 0.6 |
p-value: <0.001Mixed Models Analysis
Secondary
Graded Chronic Pain Scale Disability Score
This scale ranges from 0 (no pain-specific disability) to 100 (highest or worst pain-specific disability)
Time frame: Measured at Year 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care | Graded Chronic Pain Scale Disability Score | 52.5 units on a scale | Standard Deviation 31.6 |
| Usual Care | Graded Chronic Pain Scale Disability Score | 66.1 units on a scale | Standard Deviation 27.3 |
| No Treatment | Graded Chronic Pain Scale Disability Score | 44.8 units on a scale | Standard Deviation 29.6 |
p-value: <0.001Mixed Models Analysis
Secondary
Primary Care Visits
Time frame: Measured at Year 1
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care | Primary Care Visits | 6.3 number of primary care visits | Standard Deviation 5.8 |
| Usual Care | Primary Care Visits | 5.9 number of primary care visits | Standard Deviation 5.3 |
p-value: <0.001Poisson