Chronic Pain, Depressive Disorder, Musculoskeletal Pain
Conditions
Keywords
Primary Health Care, Patient Education, Care Managament
Brief 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).
Interventions
OTHERClinical program for pain and depression
Already described
OTHERControl
Care as usual
Sponsors
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Interference | 12 months | Brief Pain Inventory BPI |
| Depression severity | 12 months | Hopkins Symptoms Checklist-Depression HSCL-20 |
| Pain severity | 12 months | Brief Pain Inventory BPI |
| Health Related Quality of Life | 12 months | EuroQol-5D |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression severity | 3 months | Hopkins Symptoms Checklist-Depression HSCL-20 |
| Pain severity | 3 months | Brief Pain Inventory BPI |
| Health Related Quality of Life | 3 months | EuroQol-5D |
| Pain Interference | 3 months | Brief Pain Inventory BPI |
Countries
Spain
Contacts
Primary ContactEnric Aragonès, MD, PhD
Backup ContactGermán López-Cortacans, PhD
Outcome results
None listed