Primary Prevention of Major Depression Based on the Level and Profile of Risk of Primary Care Attenders: Cluster, Controlled, Randomised Trial
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

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.
    


Intervention name(s): Psychosocial Intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention we propose to test has 3 actives components. The first one is the fact of giving information to the GPs about the level and risk profile of depression of their patients. The second one is the transmission of this information from the GP to the patient. The third one is the interaction GP/Patient once both have the information about the risk profile of depression and the psychoeducational intervention that the GP will provide to the patient.
We will develop psychoeducational booklet, DVDs and websites for patients included in the intervention group.
The psychoeducative intervention will be tailored to each patient based on his/her profile, risk level and patients' risk factors.
The GPs will receive a 20-hours training course in the intervention. Moreover, we will assume a communitarian view, considering the patient as an active agent for change (empowerment). That is, GPs and patients will work together in order to promote patients' resources.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Depression; Primary prevention.; Primary health care.; Randomised controlled trial.