Effectiveness of hygienic-dietary recommendations as enhancers of antidepressant treatment in patients with depression: study protocol of a randomized controlled trial.

Background: In recent years some studies have been published supporting the efficacy of light exposure, physical activity, sleep control and a Mediterranean diet pattern on the improvement or prevention of depression. However, to our knowledge, there have been no studies using all these measures together as an adjuvant antidepressant strategy.

Methods: Multicenter, randomized, controlled, two arm-parallel, clinical trial. Eighty depressed patients undergoing standard antidepressant treatment will be advised to follow four additional hygienic-dietary recommendations about exercise, diet, sunlight exposure and sleep. Outcome measures will be assessed before and after the 6 month intervention period.

Discussion: We expect the patients in the active recommendations group to experience a greater improvement in their depressive symptoms. If so, this would be a great support for doctors who might systematically recommend these simple and costless measures, especially in primary care.

Trial Registration: ISRCTN59506583.