Multicomponent Program for the Integrated Management of Chronic Pain and Depression in Primary Care

Study Overview
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Brief Summary
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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

Detailed Description
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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: Intervention: Integrated program for depression/chronic pain, and control usual care. 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: Optimized care of major depression, Case Management, and Group psychoeducational intervention. Measurements: Blind interviews at 0, 3, 6 and 12 months. Main outcomes: Depressive symptoms (Hopkins Symptom Checklist-20): Severity, response rate and remission rate. Pain symptoms (Brief Pain Inventory). Intensity and interference, response rate. Disability by psychological problems (Sheehan Disability Inventory) Quality of life related to health (EuroQol-5D).

Official Title
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Assessment of a Multicomponent Program for the Integrated Management of Chronic Pain and Depression in Primary Care. Cluster Randomized Clinical Trial

Conditions
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Depressive Disorder, Musculoskeletal Pain, Chronic Pain

Intervention / Treatment
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* Other: Clinical program for pain and depression
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Registered patient of a participant doctor Chronic musculoskeletal pain moderate to severe (BPI>4), with more than 3 months of duration despite having received analgesic treatment Meeting the diagnostic criteria for major depression (DSM IV) at the time of recruitment. Exclusion Criteria: Patients with mental, physical, language limitation or concurrent illness that prevents understanding/participation in the assessments of the study. Patients with serious or terminal illness. Patients whit psychotic disorder, bipolar disorder or dependence disorder. Pregnant or lactating patient Patients diagnosed of fibromyalgia or somatization disorder Patient in a process of claim for a work disability Intervention for a joint prothesis planned forn next 12 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical program for pain and depression<br>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. | Other: Clinical program for pain and depression<br>* Already described<br>* Other names: DROP Program (Depression and Pain);|
| Active Comparator: Control<br>Care as usual | Other: Control<br>* Care as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression severity | Hopkins Symptoms Checklist-Depression HSCL-20 | 3 months | 
| Depression severity | Hopkins Symptoms Checklist-Depression HSCL-20 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Health Care, Patient Education, Care Managament