Intervention to Prevent Major Depression in Primary Care: A Cluster Randomized Trial

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Abstract

Background:

Not enough is known about universal prevention of depression in adults.

Objective:

To evaluate the effectiveness of an intervention to prevent major depression.

Design:

Multicenter, cluster randomized trial with sites randomly assigned to usual care or an intervention. (ClinicalTrials.gov: NCT01151982)

Setting:

10 primary care centers in each of 7 cities in Spain.

Participants:

Two primary care physicians (PCPs) and 5236 nondepressed adult patients were randomly sampled from each center; 3326 patients consented and were eligible to participate.

Intervention:

For each patient, PCPs communicated individual risk for depression and personal predictors of risk and developed a psychosocial program tailored to prevent depression.

Measurements:

New cases of major depression, assessed every 6 months for 18 months.

Results:

At 18 months, 7.39% of patients in the intervention group (95% CI, 5.85% to 8.95%) developed major depression compared with 9.40% in the control (usual care) group (CI, 7.89% to 10.92%) (absolute difference, −2.01 percentage points [CI, −4.18 to 0.16 percentage points]; P = 0.070). Depression incidence was lower in the intervention centers in 5 cities and similar between intervention and control centers in 2 cities.

Limitation:

Potential self-selection bias due to nonconsenting patients.

Conclusion:

Compared with usual care, an intervention based on personal predictors of risk for depression implemented by PCPs provided a modest but nonsignificant reduction in the incidence of major depression. Additional study of this approach may be warranted.

Primary Funding Source:

Institute of Health Carlos III.

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