Depressive DisorderDROPNCT02605278
Multicomponent Program for the Integrated Management of Chronic Pain and Depression in Primary Care
A study testing Clinical program for pain and depression in people with Depressive Disorder and Musculoskeletal Pain, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depressive Disorder, Musculoskeletal Pain, Chronic Pain
- What is being tested?
- Clinical program for pain and depression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
IDIAP Jordi Gol
Barcelona, Barcelona, 08080
Mariona Pujol, PhD, 003493 482 46 17, mpujol@idiapjgol.org
About this study
Official title: 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
Read the 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).
- Conditions
- Depressive Disorder, Musculoskeletal Pain, Chronic Pain
- Being tested
- Clinical program for pain and depression, Control
- Keywords
- Primary Health Care, Patient Education, Care Managament
- Medical subject headings
- Depressive Disorder, Musculoskeletal Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical program for pain and depressionOther
Also called DROP Program (Depression and Pain)
Already described
ControlOther
Care as usual
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Clinical program for pain and depression |
| Control | Active comparator | Care as usual Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression severity
Hopkins Symptoms Checklist-Depression HSCL-20
Measured: 12 months
Pain severity
Brief Pain Inventory BPI
Measured: 12 months
Health Related Quality of Life
EuroQol-5D
Measured: 12 months
Pain Interference
Brief Pain Inventory BPI
Measured: 12 months
Secondary outcomes (8)
Depression severity
Hopkins Symptoms Checklist-Depression HSCL-20
Measured: 3 months
Depression severity
Hopkins Symptoms Checklist-Depression HSCL-20
Measured: 6 months
Pain severity
Brief Pain Inventory BPI
Measured: 3 months
Pain severity
Brief Pain Inventory BPI
Measured: 6 months
Health Related Quality of Life
EuroQol-5D
Measured: 3 months
Health Related Quality of Life
EuroQol-5D
Measured: 6 months
Pain Interference
Brief Pain Inventory BPI
Measured: 3 months
Pain Interference
Brief Pain Inventory BPI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enric Aragonès, MD PhD, Principal investigator, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605278
- Sponsor's protocol ID
- PI14/00573
- Acronym
- DROP
- Status last verified
- Sep 2015
- First submitted
- 28 Sep 2015
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37020278Aragones 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.
PubMed 30986737Aragones 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.
PubMed 27236335
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Multicomponent Program for the Integrated Management of Chronic Pain and Depression in Primary Care. Cluster Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02605278
- Acronym / sponsor ID
- DROP / PI14/00573
- Conditions
- Depressive Disorder, Musculoskeletal Pain, Chronic Pain
- Keywords
- Primary Health Care, Patient Education, Care Managament
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical program for pain and depression | Experimental | Other: Clinical program for pain and depressionStructured 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. |
| Control | Active comparator | Other: ControlCare as usual |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical program for pain and depressionAlso: DROP Program (Depression and Pain)Already described | Other | Clinical program for pain and depression |
| ControlCare as usual | Other | Control |
Primary outcome
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
8 secondary outcomes
Depression severity
Time frame: 3 months
Depression severity
Time frame: 6 months
Pain severity
Time frame: 3 months
Pain severity
Time frame: 6 months
Health Related Quality of Life
Time frame: 3 months
Health Related Quality of Life
Time frame: 6 months
Pain Interference
Time frame: 3 months
Pain Interference
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
- Derived from this study: PubMed 37020278Rambla 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.
- Derived from this study: PubMed 30986737Aragones 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.
- Derived from this study: PubMed 27236335Aragones 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enric Aragonès, MD PhD principal investigator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical program for pain and depression in people with Depressive Disorder and Musculoskeletal Pain, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enric Aragonès, MD, PhD (0034680766923, earagones.tarte.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression severity (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02605278, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2015.