NCT02605278

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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: 1. Intervention: Integrated program for depression/chronic pain, and 2. 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: 1. Optimized care of major depression, 2. Case Management, and 3. 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).

Conditions

• Depressive Disorder
• Musculoskeletal Pain
• Chronic Pain

Interventions

Type	Name	Description
OTHER	Clinical program for pain and depression	Already described
OTHER	Control	Care as usual

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-07-01
• Completion: 2017-12-01
• First posted: 2015-11-16
• Last updated: 2015-11-16

Locations

1 site across 1 country: Spain