Approach to Mental Health Through a Frequency Modulated Auditory Intervention: A Controlled and Randomized Clinical Trial.

Objective: The clinical trial Effect of Modulated Auditory Stimulation on Interaural Auditory Perception (NCT0544189) aimed to determine whether an auditory intervention (AI)-"Bérard in 10"-can enhance the effect of standard therapies for people with anxiety and/or depression. Methods: Design: unblinded, randomized, controlled clinical trial.

Location: Mejorada del Campo Health Centre, Madrid (Primary Care).

Participants: A total of 233 patients selected by systematic sampling and meeting the following selection criteria: age of majority, absence of severe acute pathology or chronic decompensated pathology. They were evaluated with the Goldberg and Hamilton tests and classified into the Emotional Well-Being group (EWB, n = 86) or the Anxiety and/or Depression group (AD, n = 147). Just half of each group received an AI.

Intervention: Listening to classical music processed through a frequency modulator (Earducator) to attenuate abnormal frequencies, 30 min per session, two sessions a day for 5 days.

Main measurements: Hamilton Tests for Anxiety and Hamilton Test for Depression, at 3 and 6 months. Results: In the analysis by protocol, EWB with AI (n = 14) obtained lower scores in anxiety and depression at 3 and 6 months than EWB without AI (n = 36) (p < 0.05), the effects being large and moderate, respectively; AD with AI (n = 31) had lower scores on anxiety and depression at 3 months and anxiety at 6 months than AD without AI (n = 52) (p < 0.05), the effect being small. No damage reported. Conclusions: The AI "Bérard in 10" significantly prevents the onset of anxiety and depression and somewhat improves the effect of standard treatments in primary care.