Clinical trial NCT02605278: Multicomponent Program for the Integrated Management of Chronic Pain and Depression in Primary Care
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
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Disorder
Musculoskeletal Pain
Chronic Pain
Keywords: Primary Health Care, Patient Education, Care Managament
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Depression severity
timeFrame: 12 months
measure: Pain severity
timeFrame: 12 months
measure: Health Related Quality of Life
timeFrame: 12 months
measure: Pain Interference
timeFrame: 12 months
Secondary outcomes:
measure: Depression severity
timeFrame: 3 months
measure: Depression severity
timeFrame: 6 months
measure: Pain severity
timeFrame: 3 months
measure: Pain severity
timeFrame: 6 months
measure: Health Related Quality of Life
timeFrame: 3 months
measure: Health Related Quality of Life
timeFrame: 6 months
measure: Pain Interference
timeFrame: 3 months
measure: Pain Interference
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: IDIAP Jordi Gol
Study officials:
affiliation: IDIAP JORDI GOL
name: Enric Aragonès, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.