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

November 13, 2015 updated by: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08080
        • Recruiting
        • IDIAP Jordi Gol
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Care as usual
Other: Control
Care as usual
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.
Other: Clinical program for pain and depression
Already described
Other Names:
  • DROP Program (Depression and Pain)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Investigators

  • Principal Investigator: Enric Aragonès, MD PhD, IDIAP Jordi Gol

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

November 13, 2015

First Posted (Estimate)

November 16, 2015

Study Record Updates

Last Update Posted (Estimate)

November 16, 2015

Last Update Submitted That Met QC Criteria

November 13, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI14/00573

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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