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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Unknown

Conditions: Musculoskeletal Pain; Chronic Pain; Depressive Disorder

Treatments: Other: Clinical program for pain and depression; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02605278

PI14/00573

Details and patient eligibility

About

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

Full 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).

Enrollment: 330 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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330 participants in 2 patient groups

Clinical program for pain and depression

Experimental group

Description:

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.

Treatment:

Other: Clinical program for pain and depression

Control

Active Comparator group

Description:

Care as usual

Treatment:

Other: Control