PainPhase 4NCT00118430
Stepped Care for Depression and Musculoskeletal Pain
A Phase 4 study testing Stepped Care and Antidepressants in people with Pain and Depression, run by Indiana University at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of a stepped care approach in treating depression and reducing pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Depression
- What is being tested?
- Stepped Care and Antidepressants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Aug 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Moderate to severe cognitive impairment
- Schizophrenia or other psychotic disorders
- Receiving disability benefits for pain
- Anticipated life expectancy less than 12 months
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Medical Center
Indianapolis, Indiana, 46202
About this study
Official title: Stepped Care for Affective Disorders and Musculoskeletal Pain
This study will evaluate the effectiveness of a stepped care approach in treating depression and reducing pain.
Read the 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.
- Conditions
- Pain, Depression
- Being tested
- Stepped Care, Antidepressants, Usual Care
- Keywords
- Back Pain, Knee Pain, Hip Pain, Stepped Care, Antidepressant, Relaxation Techniques, Exercise
- Medical subject headings
- Pain, Depression, Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped CareBehavioural
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.
AntidepressantsDrug
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).
Usual CareDrug
Also called Standard Care
This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group.
| Study group | Role | What they receive |
|---|---|---|
| Stepped Care | Experimental | Stepped care group Receives: Behavioral: Stepped Care; Drug: Antidepressants |
| Usual Care | Active comparator | Treatment as usual group Receives: Drug: Usual Care |
| No Treatment | No intervention | Participants without depression group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Measured at Year 1
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)
Measured: Measured at Year 1
Secondary outcomes (2)
Graded Chronic Pain Scale Disability Score
This scale ranges from 0 (no pain-specific disability) to 100 (highest or worst pain-specific disability)
Measured: Measured at Year 1
Primary Care Visits
Measured: Measured at Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2005 (estimated)
- Study startSep 2004
- Primary completionJul 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Kurt Kroenke, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118430
- Sponsor's protocol ID
- R01MH071268
- Other IDs
- R01MH071268
- Status last verified
- Mar 2017
- First submitted
- 6 Jul 2005
- Last updated
- 9 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data has been published in multiple publications. Should others wish access to data for publication reasons, we are willing to share
Publications
Dube P, Kurt K, Bair MJ, Theobald D, Williams LS. The p4 screener: evaluation of a brief measure for assessing potential suicide risk in 2 randomized effectiveness trials of primary care and oncology patients. Prim Care Companion J Clin Psychiatry. 2010;12(6):PCC.10m00978. doi: 10.4088/PCC.10m00978blu.
PubMed 21494337Kroenke K, Bair MJ, Damush TM, Wu J, Hoke S, Sutherland J, Tu W. Optimized antidepressant therapy and pain self-management in primary care patients with depression and musculoskeletal pain: a randomized controlled trial. JAMA. 2009 May 27;301(20):2099-110. doi: 10.1001/jama.2009.723.
PubMed 19470987
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Care for Affective Disorders and Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT00118430
- Acronym / sponsor ID
- R01MH071268
- Conditions
- Pain, Depression
- Keywords
- Back Pain, Knee Pain, Hip Pain, Stepped Care, Antidepressant, Relaxation Techniques, Exercise
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 11 Jul 2005 (estimated)
- Results
- Posted 9 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stepped Care | Experimental | Behavioral: Stepped Care, Drug: AntidepressantsStepped care group |
| Usual Care | Active comparator | Drug: Usual CareTreatment as usual group |
| No Treatment | No intervention | –Participants without depression group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Moderate to severe cognitive impairment
- Schizophrenia or other psychotic disorders
- Receiving disability benefits for pain
- Anticipated life expectancy less than 12 months
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepped CareStepped 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. | Behavioural | Stepped Care |
| AntidepressantsParticipants 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). | Drug | Stepped Care |
| Usual CareAlso: Standard CareThis group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group. | Drug | Usual Care |
Primary outcome
Brief Pain Inventory Interference
Time frame: 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
Time frame: 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)
2 secondary outcomes
Graded Chronic Pain Scale Disability Score
Time frame: Measured at Year 1
Primary Care Visits
Time frame: Measured at Year 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21494337Dube P, Kurt K, Bair MJ, Theobald D, Williams LS. The p4 screener: evaluation of a brief measure for assessing potential suicide risk in 2 randomized effectiveness trials of primary care and oncology patients. Prim Care Companion J Clin Psychiatry. 2010;12(6):PCC.10m00978. doi: 10.4088/PCC.10m00978blu.
- Derived from this study: PubMed 19470987Kroenke K, Bair MJ, Damush TM, Wu J, Hoke S, Sutherland J, Tu W. Optimized antidepressant therapy and pain self-management in primary care patients with depression and musculoskeletal pain: a randomized controlled trial. JAMA. 2009 May 27;301(20):2099-110. doi: 10.1001/jama.2009.723.
- Individual participant dataSharing planned: Yes. Data has been published in multiple publications. Should others wish access to data for publication reasons, we are willing to share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt Kroenke, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stepped Care and Antidepressants in people with Pain and Depression, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory Interference (time frame: Measured at Year 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00118430, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.