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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

Tracking Information
First Submitted Date  ICMJE September 28, 2015
First Posted Date  ICMJE November 16, 2015
Last Update Posted Date November 16, 2015
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2015)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicomponent Program for the Integrated Management of Chronic Pain and Depression in Primary Care
Official Title  ICMJE Assessment of a Multicomponent Program for the Integrated Management of Chronic Pain and Depression in Primary Care. Cluster Randomized Clinical Trial
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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depressive Disorder
  • Musculoskeletal Pain
  • Chronic Pain
Intervention  ICMJE
  • Other: Clinical program for pain and depression
    Already described
    Other Name: DROP Program (Depression and Pain)
  • Other: Control
    Care as usual
Study Arms  ICMJE
  • 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.
    Intervention: Other: Clinical program for pain and depression
  • Active Comparator: Control
    Care as usual
    Intervention: Other: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 13, 2015)
330
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02605278
Other Study ID Numbers  ICMJE PI14/00573
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jordi Gol i Gurina Foundation
Study Sponsor  ICMJE Jordi Gol i Gurina Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Enric Aragonès, MD PhD IDIAP Jordi Gol
PRS Account Jordi Gol i Gurina Foundation
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP