Approach to Mental Health Through a Frequency Modulated Auditory Intervention: A Controlled and Randomized Clinical Trial
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 233 participants or records.
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