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This study evaluates whether the implementation of an integrated clinical program for chronic musculoskeletal pain and depression behave better clinical outcomes than the usual approach in primary care
Chronic musculoskeletal pain and depression are extremely common and relevant pathological conditions, and frequently presented as comorbid processes multiplying the impact on health, worsening the prognosis and complicating the care. The integrated management of both disorders is an opportunity to achieve better clinical outcomes.
AIM: To determinate whether the implementation of an integrated clinical program for chronic musculoskeletal pain and depression behave better clinical outcomes than the usual approach in primary care
METHODS
Design: Cluster randomized clinical trials with two arms:
Settings: Primary Care Centers in Tarragona, Spain. Patients: Adults with moderate/severe musculoskeletal pain (Brief Pain Inventory/pain intensity scale > 4 points), with more than three months of evolution and current diagnostic criteria for major depression episode (DSM-IV).
Sample: A total sample of 330 patients (165 control arm and 165 intervention arm) divided into 42 clusters of 8 patients. Cluster composition: patients registered with the same doctor.
Intervention: Structured program with integrated management for depression/ pain with three main components:
Measurements: "Blind" interviews at 0, 3, 6 and 12 months.
Main outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical program for pain and depression | Experimental | Structured program with integrated management for depression and chronic musculoskeletal pain with three main components: 1) Optimized care of major depression on the basis of a Clinical Guideline 2) Care Management, and 3) Group psychoeducational intervention. |
|
| Control | Active Comparator | Care as usual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical program for pain and depression | Other | Already described |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depression severity | Hopkins Symptoms Checklist-Depression HSCL-20 | 12 months |
| Pain severity | Brief Pain Inventory BPI | 12 months |
| Health Related Quality of Life | EuroQol-5D | 12 months |
| Pain Interference | Brief Pain Inventory BPI | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Depression severity | Hopkins Symptoms Checklist-Depression HSCL-20 | 3 months |
| Depression severity | Hopkins Symptoms Checklist-Depression HSCL-20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enric Aragonès, MD, PhD | Contact | 0034680766923 | earagones.tarte.ics@gencat.cat | |
| Germán López-Cortacans, PhD | Contact | 0034627392500 | glopez.tarte.ics@gencat.cat |
| Name | Affiliation | Role |
|---|---|---|
| Enric Aragonès, MD PhD | Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IDIAP Jordi Gol | Recruiting | Barcelona | Barcelona | 08080 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37020278 | Derived | Rambla C, Aragones E, Palleja-Millan M, Tome-Pires C, Lopez-Cortacans G, Sanchez-Rodriguez E, Miro J. Short and long-term predictors of pain severity and interference in primary care patients with chronic musculoskeletal pain and depression. BMC Musculoskelet Disord. 2023 Apr 5;24(1):270. doi: 10.1186/s12891-023-06357-2. | |
| 30986737 |
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| Control | Other | Care as usual |
|
| 6 months |
| Pain severity | Brief Pain Inventory BPI | 3 months |
| Pain severity | Brief Pain Inventory BPI | 6 months |
| Health Related Quality of Life | EuroQol-5D | 3 months |
| Health Related Quality of Life | EuroQol-5D | 6 months |
| Pain Interference | Brief Pain Inventory BPI | 3 months |
| Pain Interference | Brief Pain Inventory BPI | 6 months |
| Aragones E, Rambla C, Lopez-Cortacans G, Tome-Pires C, Sanchez-Rodriguez E, Caballero A, Miro J. Effectiveness of a collaborative care intervention for managing major depression and chronic musculoskeletal pain in primary care: A cluster-randomised controlled trial. J Affect Disord. 2019 Jun 1;252:221-229. doi: 10.1016/j.jad.2019.04.004. Epub 2019 Apr 8. |
| 27236335 | Derived | Aragones E, Lopez-Cortacans G, Caballero A, Pinol JL, Sanchez-Rodriguez E, Rambla C, Tome-Pires C, Miro J. Evaluation of a multicomponent programme for the management of musculoskeletal pain and depression in primary care: a cluster-randomised clinical trial (the DROP study). BMC Psychiatry. 2016 Mar 16;16:69. doi: 10.1186/s12888-016-0772-2. |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D059352 | Musculoskeletal Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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