A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression

Background: Anxiety disorders are among the most prevalent mental disorders and are usually treated with medication and/or psychotherapy. When anxiety disorders are accompanied with comorbid depression, this further complicates the treatment process. Medication compliance is a common problem due to adverse side effects and new and effective treatments that have minimal side effects are needed for the treatment of anxiety and depression. This study used a randomized, double-blind, sham controlled design to examine the effectiveness of CES as a treatment for anxiety disorders and comorbid depression in a primary care setting. The study was registered at clinicaltrials.gov, NCT01533415. Methods: One hundred and fifteen participants, age 18 years and over, with a primary diagnosis of an anxiety disorder were enrolled from February 2012 to December 2012 The Hamilton Rating Scale for Anxiety (HAM-A) and the Hamilton Depression Rating Scale(17) (HAM-D-17) were used for baseline and outcome measures at weeks one, three, and five. Response to treatment was defined as a reduction of >= 50% or more on these measures. Results: Analysis of covariance revealed a significant difference between the active CBS group and the sham CBS group on anxiety (p=0.001, d=0.94) and on depression (p=0.001, (d=0.78) from baseline to endpoint of study in favor of the active CBS group. Conclusions: CBS significantly decreases anxiety and comorbid depression. Subjects reported no adverse events during the study. (C) 2014 Elsevier B.V. All rights reserved.