NCT02605278

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 16, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 16, 2015

Status Verified

September 1, 2015

Enrollment Period

2.5 years

First QC Date

September 28, 2015

Last Update Submit

November 13, 2015

Conditions

Depressive DisorderMusculoskeletal PainChronic Pain

Keywords

Primary Health Care, Patient Education, Care Managament

Outcome Measures

Primary Outcomes (4)

  • Depression severity

    Hopkins Symptoms Checklist-Depression HSCL-20

    12 months

  • Pain severity

    Brief Pain Inventory BPI

    12 months

  • Health Related Quality of Life

    EuroQol-5D

    12 months

  • Pain Interference

    Brief Pain Inventory BPI

    12 months

Secondary Outcomes (8)

  • Depression severity

    3 months

  • Depression severity

    6 months

  • Pain severity

    3 months

  • Pain severity

    6 months

  • Health Related Quality of Life

    3 months

  • +3 more secondary outcomes

Study Arms (2)

Clinical program for pain and depression

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Care as usual

Other: Control

Interventions

Clinical program for pain and depressionOTHER

Already described

Also known as: DROP Program (Depression and Pain)
Clinical program for pain and depression
ControlOTHER

Care as usual

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IDIAP Jordi Gol

Barcelona, Barcelona, 08080, Spain

RECRUITING

Related Publications (3)

  • Rambla C, Aragones E, Palleja-Millan M, Tome-Pires C, Lopez-Cortacans G, Sanchez-Rodriguez E, Miro J. Short and long-term predictors of pain severity and interference in primary care patients with chronic musculoskeletal pain and depression. BMC Musculoskelet Disord. 2023 Apr 5;24(1):270. doi: 10.1186/s12891-023-06357-2.

    PMID: 37020278DERIVED

  • 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.

    PMID: 30986737DERIVED

  • 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.

    PMID: 27236335DERIVED

MeSH Terms

Conditions

Depressive DisorderMusculoskeletal PainChronic Pain

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersMuscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Enric Aragonès, MD PhD

    Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Enric Aragonès, MD, PhD

CONTACT

0034680766923earagones.tarte.ics@gencat.cat

Germán López-Cortacans, PhD

CONTACT

0034627392500glopez.tarte.ics@gencat.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2015

First Posted

November 16, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

November 16, 2015

Record last verified: 2015-09

Locations

ES(1)