Multicomponent Program for the Integrated Management of Chronic Pain and Depression in Primary Care (DROP)
Primary Purpose
Depressive Disorder, Musculoskeletal Pain, Chronic Pain
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Clinical program for pain and depression
Control
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder focused on measuring Primary Health Care, Patient Education, Care Managament
Eligibility 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.
Sites / Locations
- IDIAP Jordi GolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clinical program for pain and depression
Control
Arm Description
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.
Care as usual
Outcomes
Primary Outcome Measures
Depression severity
Hopkins Symptoms Checklist-Depression HSCL-20
Pain severity
Brief Pain Inventory BPI
Health Related Quality of Life
EuroQol-5D
Pain Interference
Brief Pain Inventory BPI
Secondary Outcome Measures
Depression severity
Hopkins Symptoms Checklist-Depression HSCL-20
Depression severity
Hopkins Symptoms Checklist-Depression HSCL-20
Pain severity
Brief Pain Inventory BPI
Pain severity
Brief Pain Inventory BPI
Health Related Quality of Life
EuroQol-5D
Health Related Quality of Life
EuroQol-5D
Pain Interference
Brief Pain Inventory BPI
Pain Interference
Brief Pain Inventory BPI
Full Information
NCT ID
NCT02605278
First Posted
September 28, 2015
Last Updated
November 13, 2015
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
1. Study Identification
Unique Protocol Identification Number
NCT02605278
Brief Title
Multicomponent Program for the Integrated Management of Chronic Pain and Depression in Primary Care
Acronym
DROP
Official Title
Assessment of a Multicomponent Program for the Integrated Management of Chronic Pain and Depression in Primary Care. Cluster Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Intervention: Integrated program for depression/chronic pain, and
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:
Optimized care of major depression,
Case Management, and
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Musculoskeletal Pain, Chronic Pain
Keywords
Primary Health Care, Patient Education, Care Managament
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
330 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clinical program for pain and depression
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Care as usual
Intervention Type
Other
Intervention Name(s)
Clinical program for pain and depression
Other Intervention Name(s)
DROP Program (Depression and Pain)
Intervention Description
Already described
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Care as usual
Primary Outcome Measure Information:
Title
Depression severity
Description
Hopkins Symptoms Checklist-Depression HSCL-20
Time Frame
12 months
Title
Pain severity
Description
Brief Pain Inventory BPI
Time Frame
12 months
Title
Health Related Quality of Life
Description
EuroQol-5D
Time Frame
12 months
Title
Pain Interference
Description
Brief Pain Inventory BPI
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Depression severity
Description
Hopkins Symptoms Checklist-Depression HSCL-20
Time Frame
3 months
Title
Depression severity
Description
Hopkins Symptoms Checklist-Depression HSCL-20
Time Frame
6 months
Title
Pain severity
Description
Brief Pain Inventory BPI
Time Frame
3 months
Title
Pain severity
Description
Brief Pain Inventory BPI
Time Frame
6 months
Title
Health Related Quality of Life
Description
EuroQol-5D
Time Frame
3 months
Title
Health Related Quality of Life
Description
EuroQol-5D
Time Frame
6 months
Title
Pain Interference
Description
Brief Pain Inventory BPI
Time Frame
3 months
Title
Pain Interference
Description
Brief Pain Inventory BPI
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enric Aragonès, MD, PhD
Phone
0034680766923
Email
earagones.tarte.ics@gencat.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Germán López-Cortacans, PhD
Phone
0034627392500
Email
glopez.tarte.ics@gencat.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enric Aragonès, MD PhD
Organizational Affiliation
IDIAP JORDI GOL
Official's Role
Principal Investigator
Facility Information:
Facility Name
IDIAP Jordi Gol
City
Barcelona
ZIP/Postal Code
08080
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariona Pujol, PhD
Phone
003493 482 46 17
Email
mpujol@idiapjgol.org
12. IPD Sharing Statement
Citations:
PubMed Identifier
30986737
Citation
Aragones E, Rambla C, Lopez-Cortacans G, Tome-Pires C, Sanchez-Rodriguez E, Caballero A, Miro J. Effectiveness of a collaborative care intervention for managing major depression and chronic musculoskeletal pain in primary care: A cluster-randomised controlled trial. J Affect Disord. 2019 Jun 1;252:221-229. doi: 10.1016/j.jad.2019.04.004. Epub 2019 Apr 8.
Results Reference
derived
PubMed Identifier
27236335
Citation
Aragones E, Lopez-Cortacans G, Caballero A, Pinol JL, Sanchez-Rodriguez E, Rambla C, Tome-Pires C, Miro J. Evaluation of a multicomponent programme for the management of musculoskeletal pain and depression in primary care: a cluster-randomised clinical trial (the DROP study). BMC Psychiatry. 2016 Mar 16;16:69. doi: 10.1186/s12888-016-0772-2.
Results Reference
derived
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Multicomponent Program for the Integrated Management of Chronic Pain and Depression in Primary Care
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