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

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ClinicalTrials.gov Identifier: NCT02605278
Recruitment Status : Unknown
Verified September 2015 by Jordi Gol i Gurina Foundation.
Recruitment status was:  Recruiting
First Posted : November 16, 2015
Last Update Posted : November 16, 2015
Sponsor:
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

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

Condition or disease Intervention/treatment Phase
Depressive Disorder Musculoskeletal Pain Chronic Pain Other: Clinical program for pain and depression Other: Control Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of a Multicomponent Program for the Integrated Management of Chronic Pain and Depression in Primary Care. Cluster Randomized Clinical Trial
Study Start Date : January 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
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 Name: DROP Program (Depression and Pain)

Active Comparator: Control
Care as usual
Other: Control
Care as usual




Primary Outcome Measures :
  1. Depression severity [ Time Frame: 12 months ]
    Hopkins Symptoms Checklist-Depression HSCL-20

  2. Pain severity [ Time Frame: 12 months ]
    Brief Pain Inventory BPI

  3. Health Related Quality of Life [ Time Frame: 12 months ]
    EuroQol-5D

  4. Pain Interference [ Time Frame: 12 months ]
    Brief Pain Inventory BPI


Secondary Outcome Measures :
  1. Depression severity [ Time Frame: 3 months ]
    Hopkins Symptoms Checklist-Depression HSCL-20

  2. Depression severity [ Time Frame: 6 months ]
    Hopkins Symptoms Checklist-Depression HSCL-20

  3. Pain severity [ Time Frame: 3 months ]
    Brief Pain Inventory BPI

  4. Pain severity [ Time Frame: 6 months ]
    Brief Pain Inventory BPI

  5. Health Related Quality of Life [ Time Frame: 3 months ]
    EuroQol-5D

  6. Health Related Quality of Life [ Time Frame: 6 months ]
    EuroQol-5D

  7. Pain Interference [ Time Frame: 3 months ]
    Brief Pain Inventory BPI

  8. Pain Interference [ Time Frame: 6 months ]
    Brief Pain Inventory BPI



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02605278


Contacts
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Contact: Enric Aragonès, MD, PhD 0034680766923 earagones.tarte.ics@gencat.cat
Contact: Germán López-Cortacans, PhD 0034627392500 glopez.tarte.ics@gencat.cat

Locations
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Spain
IDIAP Jordi Gol Recruiting
Barcelona, Spain, 08080
Contact: Mariona Pujol, PhD    003493 482 46 17    mpujol@idiapjgol.org   
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Investigators
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Principal Investigator: Enric Aragonès, MD PhD IDIAP Jordi Gol

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT02605278     History of Changes
Other Study ID Numbers: PI14/00573
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: November 16, 2015
Last Verified: September 2015
Keywords provided by Jordi Gol i Gurina Foundation:
Primary Health Care, Patient Education, Care Managament
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Musculoskeletal Pain
Chronic Pain
Mood Disorders
Mental Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases