1、A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression Barclay TH, Barclay RD. A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression. Journal of Affective Disorders, 164:171-177, 2014. Presented at the American Psychological As
2、sociation National Conference, Honolulu, HI, July 2013. OBJECTIVE The purpose of this study was to examine the efficacy of Alpha-Stim CES for the treatment of anxiety and comorbid depression. Design This was a 5 week study that used a randomized, sham controlled, double-blind design in which subject
3、s in the treatment and sham groups participated in a daily one hour treatment of CES using active or sham Alpha-Stim CES devices. The sham device was identical to the active CES device, except it did not conduct an electrical current. The active CES device was set to 100 A, a subsensory level. The s
4、ubjects, investigators, physicians and staff were all masked as to the identity of the device. Primary Effectiveness Endpoint The primary effectiveness endpoint was the change from baseline in the last post-treatment scores on the Hamilton Anxiety Rating Scale (HAM-A) compared to the sham treatment
5、at the endpoint of the 5 week study. Secondary Outcome Measures The secondary outcome measure was the change from baseline in the last post-treatment scores on the Hamilton Depression Rating Scale (HAM-D17) compared to the sham treatment at the endpoint of the 5 week study. Key Inclusion Criteria Di
6、agnosis of an anxiety disorder was verified by a licensed clinical psychologist in an interview using the DSM-IV criteria with a score 15 on the HAM-A. Protocol Summary Baseline measures were done prior to the first CES treatment. Subjects had 5 weeks of daily CES treatment for 60 minutes with eithe
7、r an active or sham device. Outcome measures were done at the end of 1, 3 and 5 weeks. Outcome Measures The Hamilton Anxiety Rating Scale and the Hamilton Depression Rating Scale 17 were used to quantify the severity of anxiety and depressive symptoms and to identify the response to Alpha-Stim CES.
8、Pre-Specified Criteria for Success Pre-specified criteria for success was set at 50% improvement for anxiety and 50% improvement for depression. Dworkin 2008, established that 50% improvement is substantial clinical importance. Subjects Of the 115 subjects who enrolled in the study, 108 subjects com
9、pleted the study. There were 57 subjects in the active CES group and 51 subjects in the sham CES group. Anxiety There was a significant difference between the active and sham groups for anxiety from baseline to endpoint of study (p0.001, d=0.94). The mean decrease in HAM-A scores among the active gr
10、oup was 16.14. This was more than 2 times the mean decrease (7.58) of the sham group (See Figure 1). Eighty-three percent (83%) of the active CES group had a decrease of 50% decrease in anxiety scores on the HAM-A from baseline to endpoint of study. Depression There was a significant difference betw
11、een the active and sham groups for depression from baseline to endpoint of study (p0.001, d=0.78). The mean decrease in HAM-D17 scores among the active group was 8.04. This was more than 2.3 times the mean decrease of (3.26) of the sham group (See Figure 2). Eighty-two percent (82%) of the active CE
12、S group had a 50% decrease in depression scores on the HAM-D17 from the baseline to the endpoint of study. CONCLUSION This is a strong study of 115 patients that used a randomized, sham controlled, double-blind design and was adequately powered. Individuals had to meet the DSM-IV criteria for an anx
13、iety disorder to be in the study. A pre-qualified measurement of success was set at 50% decrease in anxiety. Eighty-three percent (83%) of the patients achieved this substantial mark. Alpha-Stim CES was shown to be an effective treatment option for anxiety and comorbid depression. Author Affiliations Tim Barclay Ph.D. Associate Professor, Department of Psychology, Liberty University, Lynchburg, VA; Raymond Barclay Ph.D. Associate Vice President for Analytics and Decision Support at Stetson University, Daytona Beach, FL.
