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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 2017

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

  • Other: Clinical program for pain and depression
    • Already described
  • Other: Control
    • Care as usual

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: Control
    • Care as usual

Clinical Trial Outcome Measures

Primary Measures

  • Depression severity
    • Time Frame: 12 months
    • Hopkins Symptoms Checklist-Depression HSCL-20
  • Pain severity
    • Time Frame: 12 months
    • Brief Pain Inventory BPI
  • Health Related Quality of Life
    • Time Frame: 12 months
    • EuroQol-5D
  • Pain Interference
    • Time Frame: 12 months
    • Brief Pain Inventory BPI

Secondary Measures

  • Depression severity
    • Time Frame: 3 months
    • Hopkins Symptoms Checklist-Depression HSCL-20
  • Depression severity
    • Time Frame: 6 months
    • Hopkins Symptoms Checklist-Depression HSCL-20
  • Pain severity
    • Time Frame: 3 months
    • Brief Pain Inventory BPI
  • Pain severity
    • Time Frame: 6 months
    • Brief Pain Inventory BPI
  • Health Related Quality of Life
    • Time Frame: 3 months
    • EuroQol-5D
  • Health Related Quality of Life
    • Time Frame: 6 months
    • EuroQol-5D
  • Pain Interference
    • Time Frame: 3 months
    • Brief Pain Inventory BPI
  • Pain Interference
    • Time Frame: 6 months
    • Brief Pain Inventory BPI

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jordi Gol i Gurina Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Enric Aragon├Ęs, MD PhD, Principal Investigator, IDIAP Jordi Gol
  • Overall Contact(s)
    • Enric Aragon├Ęs, MD, PhD, 0034680766923, earagones.tarte.ics@gencat.cat

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