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

Chronic Pain Clinical Trial

— DROP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02605278
• Other study ID #: PI14/00573
• Status: Recruiting
• Phase: N/A
• First received: September 28, 2015
• Last updated: November 13, 2015
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2015
• Source: Jordi Gol i Gurina Foundation
• Contact: Enric Aragonès, MD, PhD
• Phone: 0034680766923
• Email: earagones.tarte.ics[@]gencat.cat
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Depression
• Depressive Disorder
• Musculoskeletal Pain

Intervention

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

Locations

Country	Name	City	State
Spain	IDIAP Jordi Gol	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression severity	Hopkins Symptoms Checklist-Depression HSCL-20	12 months	No
Primary	Pain severity	Brief Pain Inventory BPI	12 months	No
Primary	Health Related Quality of Life	EuroQol-5D	12 months	No
Primary	Pain Interference	Brief Pain Inventory BPI	12 months	No
Secondary	Depression severity	Hopkins Symptoms Checklist-Depression HSCL-20	3 months	No
Secondary	Depression severity	Hopkins Symptoms Checklist-Depression HSCL-20	6 months	No
Secondary	Pain severity	Brief Pain Inventory BPI	3 months	No
Secondary	Pain severity	Brief Pain Inventory BPI	6 months	No
Secondary	Health Related Quality of Life	EuroQol-5D	3 months	No
Secondary	Health Related Quality of Life	EuroQol-5D	6 months	No
Secondary	Pain Interference	Brief Pain Inventory BPI	3 months	No
Secondary	Pain Interference	Brief Pain Inventory BPI	6 months	No