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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02605278
Other study ID # PI14/00573
Secondary ID
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


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
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