Kirsch TB, Kuhn J, Price LR, Marksberry J, Haltiwanger SG. A novel medical device that relieves anxiety, depression and pain while improving sleep in a population of teachers. Journal of Depression and Anxiety, 2019; 8:334.

Funding Source, Location of Study or Author’s Affiliation
This study was supported by a research grant from The Brazos Foundation, an independent charity in Mineral Wells, Texas, which paid for the health screenings. The Alpha-Stim^® devices used in this study were provided free of charge by Electromedical Products International, Inc.

Device
Alpha-Stim^® AID

Key Variables
Anxiety, insomnia, depression, and pain

Objective
This study was conducted to confirm the benefits of Alpha-Stim cranial electrotherapy stimulation (CES) technology as an effective non-drug treatment for anxiety, mood, depression, sleep, and pain in teachers following a successful pilot study at the Leigh Academy, Dartford, United Kingdom. The second objective was to determine whether a new Alpha-Stim smartphone app was a reliable method of evaluating the effectiveness of using the device to treat anxiety, insomnia, depression, and pain.

Design
Thirty-five (35) teachers (29 females and 6 males) in the Mineral Wells, Texas Independent School District, volunteered to participate in a study to reduce anxiety, depression, insomnia, and pain. It was a six-week open-label design where participants tracked their progress using a new smartphone app to record their symptoms at least five days per week. The subjects were encouraged to use the device for 20-60 minutes any time of day and for any indication. Baseline measurements were taken prior to starting the six-week study.

Primary Outcome Measures

• Anxiety (primary outcome 1) subjects reported their perceived level of anxiety five days per week (twice per day – pretest-posttest) over a six-week period using an 11-point Numerical Rating Scale representing a continuous level of measurement. A value of 0 signifies the absence of symptoms and a value of 10 signifies a high level of discomfort perceived by subjects. Ratings data were recorded daily (pretest and posttest) using a smartphone application.
• Depression (primary outcome 2) subjects reported their perceived level of depression five days per week (twice per day – pretest-posttest) over a six-week period using an 11-point Numerical Rating Scale representing a continuous level of measurement. A value of 0 signifies the absence of symptoms and a value of 10 signifies a high level of discomfort perceived by subjects. Rating data were recorded daily (pretest and posttest) using a smartphone application.
• Insomnia (primary outcome 3) subjects reported their perceived level of insomnia five days per week (twice per day – pretest-posttest) over a six-week period using an 11-point Numerical Rating Scale representing a continuous level of measurement. A value of 0 signifies the absence of symptoms and a value of 10 signifies a high level of discomfort perceived by subjects. Rating data were recorded daily (pretest and posttest) using a smartphone application.
• Pain (primary outcome 4) subjects reported their perceived level of pain five days per week (twice per day – pretest-posttest) over a six-week period using an 11-point Numerical Rating Scale representing a continuous level of measurement. A value of 0 signifies the absence of symptoms and a value of 10 signifies a high level of discomfort perceived by subjects. Rating data were recorded daily (pretest and posttest) using a smartphone application.

Secondary Outcome Measures
The second purpose of this study was to examine the effectiveness of monitoring Alpha-Stim CES treatment using a smartphone application. Outcome measures were pre-post scores used in monitoring anxiety, depression, insomnia, pain, and stress in a sample of teachers.

Key Inclusion Criteria

• Subjects needed to be in good medical health or have stable chronic medical conditions.

Key Exclusion Criteria

• Excluded was a diagnosis of any other mental disorder g., substance use disorder, eating disorder, bipolar disorder, non-affective psychosis.
• Pregnancy
• Implanted medical device (e.g., a pacemaker, defibrillator, cochlear implant, spinal cord stimulator, or deep brain stimulator).

Protocol Summary

• Participants were instructed to turn the current on the Alpha-Stim to the point of feeling dizziness or vertigo, then turning the current down slightly until the feeling dissipates, for 20-60 minutes daily. The frequency of the waveform was constant at 0.5 Hz, and the current was adjustable from 100–500 uA.
• At pretest (baseline) and posttest, data on outcome measures were recorded as perceived levels of discomfort specific to the teachers’ anxiety, depression, insomnia, and pain.
• The study was conducted for six weeks with a smartphone app, during which time they monitored themselves at least five days per week.
• Participants were permitted to use the device any time of day and for any indication. At the end of six weeks, they were asked to complete a survey of perceived effectiveness.
• The smartphone application used by subjects for reporting their perceived level of insomnia, pain, anxiety, depression, and stress includes an 11-point scale representing a continuous level of measurement expressed as values of 0–10. A value of zero (0) signified the absence of any symptoms and a value of ten (10) signified a high level of discomfort as perceived by the participants.

Statistical Analysis Plan
A priori sample size calculations were not performed, a total convenience sample of 35 subjects volunteered and were screened for inclusion in the study. No formal study hypotheses were articulated. The goal of the study was to conduct a field trial to determine the efficacy of a newly developed smartphone app. No missing data were present.

An analysis to determine missing data (e.g., MCAR, MAR or MNAR) was not conducted or missing data replacement algorithm was used. Consequently, no Intent-to-Treat analysis was conducted. Instead, a Complete Case approach was used in all statistical analyses. The primary analysis was mixed-model nested within-subjects analysis to determine any consistent differences on the primary outcome measures within subjects over time.

Results

Subjects
A total of 29 female and 6 male teachers between the ages of 22 and 60 years participated in the study over the full six weeks.

Data Analysis
Data were analyzed using the student t-test comparing pre and posttest measurements. The statistical analyses revealed highly significant improvement (p<0.001) in anxiety, depression, insomnia, and pain. The effect size Cohen’s d values from a total of 237 treatments were greater than 2 standard deviations for all outcome measures indicating a high level of practical change from baseline to posttest supporting the capability of Alpha-Stim CES technology in reducing self-perceived symptoms and the ability to monitor progress on the Alpha-Stim app.

Decrease in mean anxiety, depression, insomnia, pain, and stress scores over 6 weeks.

Conclusion
The treatment effect with Alpha-Stim CES on anxiety, insomnia, depression, and pain was consistent with prior surveys and confirmed the precision of the new app in determining progress from a single treatment and a series of treatments. Anxiety was the most selected condition treated. Insomnia showed the greatest improvement in this study, followed closely by depression. During the study, each participant was instructed to report any discomfort or perceived safety issues. No participant reported any safety-related problems verbally or during treatment. This study established that Alpha-Stim is a successful non-drug treatment of anxiety, insomnia, and depression. The authors state Alpha-Stim is a good treatment option for individuals concerned about the side effects of medications to treat these conditions.

Limitations
The small sample size of this study consisted mostly of females, which may impact the generalizability of the findings. There were no formal a priori hypotheses and or a priori power calculations to determine minimum sample size.

Study Quality: FAIR