Primary Prevention of Major Depression Based on the Level and Profile of Risk of Primary Care Attenders: Cluster, Controlled, Randomised Trial

Not Applicable

Completed

• Conditions: Depression

• Registration Number: NCT01151982
• Lead Sponsor: The Mediterranean Institute for the Advance of Biotechnology and Health Research

Brief Summary

The main objective is to measure the effectiveness of a new intervention for primary prevention of major depression based on the level and profile of risk of primary care attendees. Among the secondary objectives is to evaluate the cost-effectiveness and cost-utility of the intervention versus usual care. METHODS: This is a cluster, randomised controlled trial of a community intervention with cluster at the level of practice. It will be undertaken in primary medical care in 7 Spanish cities and 5 autonomous communities.The aim is to evaluate a new intervention for primary prevention of major depression based on patients' level and profile of risk. Family doctors in the intervention practices will provide the intervention for patients at risk. Patients at risk who are recruited in control practices will receive usual primary care. The main outcome is the accumulated incidence of major depression (measured by CIDI) during the follow-up. The investigators will assess main outcomes and other covariables at baseline, 6, 12, and 18 months. A random sample of 3,381 primary care attendees (1,690 for each arm), aged 18-75 and without major depression will be recruited in 70 health centres (140 family doctors) in 7 cities. The investigators shall undertake a logistic regression multilevel model with 4 levels (time, patient, doctor and health centre). The investigators shall also undertake multivariate gamma and quantile regression to assess respectively the cost-effectiveness and cost-utility of the new intervention versus usual care, estimating their standard errors by bootstrap.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-25
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Study Start: 2010-10
• Primary Completion: 2012-07
• Study Completion: 2013-01
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3326

Inclusion Criteria

• Patients among those attending to primary care centers.

Exclusion Criteria

• Age under 18 or over 75 years.
• Unable to understand or speak Spanish.
• Represented patients (that is, someone else comes to visit on behalf of the patient).
• Cognitive impairment.
• Psychosis.
• Terminal illness.
• Planning to be outside of the the city during 4 or more months during the next 18 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Accumulated incidence of major depression	18 months

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness and cost-utility	18 months	To evaluate the cost-effectiveness and cost-utility of the intervention versus usual care.

Trial Locations

Locations (1)

Servicio Andaluz de Salud. Distrito Sanitario Málaga; 🇪🇸 Málaga, Spain