Depression Clinical Trial
— predictD-CCRTOfficial title:
Primary Prevention of Major Depression Based on the Level and Profile of Risk of Primary Care Attenders: Cluster, Controlled, Randomised Trial
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.
Status | Completed |
Enrollment | 3326 |
Est. completion date | January 2013 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Spain | Servicio Andaluz de Salud. Distrito Sanitario Málaga | Málaga |
Lead Sponsor | Collaborator |
---|---|
The Mediterranean Institute for the Advance of Biotechnology and Health Research | Andaluz Health Service, Carlos III Health Institute, Preventive Services and Health Promotion Research Network |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accumulated incidence of major depression | 18 months | No | |
Secondary | Cost-effectiveness and cost-utility | To evaluate the cost-effectiveness and cost-utility of the intervention versus usual care. | 18 months | No |
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