Reducing Sheriff’s Officers’ Symptoms of Depression Using Cranial Electrotherapy Stimulation (CES): A Control Experimental Study

Mellen, Ronald R. and Mackey, Wade. Reducing Sheriff’s Officers’ Symptoms of Depression Using Cranial Electrotherapy Stimulation (CES): A Control Experimental Study. The Correctional Psychologist. 2009; 41(1):9-15. Download Article

Device
Alpha-Stim®

Key Variables
Depression, Anxiety

Objective
To evaluate the effect of a specified treatment course with CES on sheriff officers’ depression and anxiety when compared to sham treatment under the same experimental conditions in subjects meeting the inclusion and exclusion criteria.

Design
An IRB approved 3 week randomized, sham treatment controlled, double-blind clinical trial. The sham device was identical in appearance to the active CES device, but did not conduct an electrical current. The active CES device was set to 100 µA, a subsensory level. The subjects and investigators were masked to the identity of the device.

Primary Effectiveness Endpoints
The primary effectiveness endpoint was the change from baseline in the last post-treatment scores on the outcome depression measures (BDI and BSI-D) and anxiety measures (BAI and BSI-A) compared to the sham treatment group at the endpoint of the study.

Key Inclusion Criteria
• Officers from the Sheriff’s staff ≥ 21 years of age.

Key Exclusion Criteria
• Pregnancy.
• Presence of implanted pacemakers, pumps or stimulators.

Protocol Summary
Randomization assignment was established prior to the start of the study. Evaluations of primary effectiveness endpoint measures were taken at baseline 2 days before treatment began. Post-assessment were taken the week following each subject’s final treatment. Following the baseline tests, subjects were taught to use the CES devices and were instructed to do a CES treatment for 20 minutes daily for 20 days. While doing a CES treatment, subjects went about their daily tasks.

Device Application Protocol
The active CES device was pre-set and locked by the manufacturer at 100 µA which is a subsensory level. The sham CES device was pre-set and locked by the manufacturer so that it did not emit electricity. The length of CES treatments was also pre-set and locked by the manufacturer for both the active and sham devices.

Study Blinding
The subjects, investigators and staff were masked to the identity of the devices.

Outcome Measures
The Beck Anxiety Inventory was used to measure anxiety (Beck et al, 1988a) and the Beck Depression Inventory was used to measure depression (Beck et al., 1988b). Both scales have established reliability and validity. The Brief Symptom Inventory Anxiety Subscale and the Brief Symptom Inventory Depression Subscale were also used to measure anxiety and depression. The Brief Symptom Inventory has established reliability and validity (Meachen et al., 2008).

Results

Subjects
A total of 21 subjects completed the study, 10 females and 11 males.

Data Analysis
Data were analyzed using the independent-samples t-test to compare the difference between the active CES and sham groups on depression and anxiety scores.

Depression
The active CES group had significantly lower depression scores on the BDI (p<0.05) and the BSI-D (p< 0.01) than the sham group.

Anxiety
There was no significant difference on anxiety scores between the active CES and sham group. The unexpected non-significant result for anxiety is most likely due to a protocol deviation. Because of a heavy workload for subjects who were parole officers, outcome measurement of state (situational) anxiety and depression were rescheduled and done one week after the final CES treatment. While the findings for depression were stable and remained significant, post-test evaluations for state anxiety should have been done immediately after the completion of the last CES treatment as state anxiety varies depending on the immediate situation. This is the most likely reason for the non-significant anxiety findings taken one week after the final CES treatment. Table 1 shows the results of statistical analyses of the outcome measures.

 

Table 1. P-Values for Comparison of Active CES and Sham groups on depression and anxiety outcome measures.

Quality of the Research
Strength of this study are: the Alpha-Stim double-blind, sham controlled RCT protocol was used; and active CES devices were set at the subsensory level of 100 µA and sham CES devices set so they did not emit electricity. The CES devices were pre-set to these specifications by the manufacturer. Limitations of the study are: the small N; and endpoint measures were not taken as scheduled in the protocol but rather one week after the final CES treatment because of an unexpected heavy workload that interfered with the clinical trial. Change in depression was stable and significant, but change in state anxiety was non-significant. Since state anxiety changes from moment to moment with the situation, the deviation from the Alpha-Stim CES protocol in the measurement of anxiety one week later as opposed to right after the last CES treatment most likely accounts for the non-significant findings for anxiety.

Author Affiliations
RRM, Associate Professor, Department of Criminal Justice, Jackson State University, Jackson, AL. WM, Visiting Professor, Department of Criminal Justice, Jackson State University, Jackson, AL.

References
Beck, Aaron T.; Epstein, Norman; Brown, Gary; Steer, Robert A. An inventory for measuring clinical anxiety: Psychometric properties. Journal of Consulting and Clinical Psychology, 1988a, 56(6), 893-897.

Beck AT, Steer RA, Garbin MG. Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clinical Psychology Review, 1988b, 8(1), 77-100.

Meachen SJ, Hanks RA, Millis SR, Rapport LJ. The reliability and validity of the brief symptom inventory-18 in persons with traumatic brain injury. Archives of Physical Medicine and Rehabilitation. 2008 May;89(5):958-65.