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

Not Applicable

• Conditions: Depressive Disorder; Musculoskeletal Pain; Chronic Pain
• Interventions: Other: Control; Other: Clinical program for pain and depression

• Registration Number: NCT02605278
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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).

Study Timeline

• Study Start: 2015-01
• Status Verified: 2015-09
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-11-13
• Last Update Submitted: 2015-11-13
• Study First Posted: 2015-11-16
• Last Update Posted: 2015-11-16
• Primary Completion: 2017-07
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 330

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Care as usual
Clinical program for pain and depression	Clinical program for pain and depression	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.

Primary Outcome Measures

Name	Time	Method
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
Pain Interference	12 months	Brief Pain Inventory BPI

Secondary Outcome Measures

Name	Time	Method
Depression severity	6 months	Hopkins Symptoms Checklist-Depression HSCL-20
Pain severity	6 months	Brief Pain Inventory BPI
Health Related Quality of Life	6 months	EuroQol-5D
Pain Interference	6 months	Brief Pain Inventory BPI

Trial Locations

Locations (1)

IDIAP Jordi Gol; 🇪🇸 Barcelona, Spain