Military Service Member and Veteran Self-Reports of Efficacy of Cranial Electrotherapy Stimulation for Anxiety, PTSD, Insomnia, and Depression

 

Kirsch, D.L., Price, L.R., Nichols, F., Marksberry, J.A., & Platoni, K.T. Military Service Member and Veteran Self-Reports of Efficacy of Cranial Electrotherapy Stimulation for Anxiety, PTSD, Insomnia, and Depression. The Army Medical Department Journal. 2014; 46-54.

Funding Source, Location of Study or Author’s Affiliation
Science and Education at Electromedical Products International, Mineral Wells, Texas

Device
Alpha-Stim®

Key Variable
Perceptions of efficacy of Alpha-Stim for treatment of anxiety, insomnia, depression, and pain.

Objective
Understand Service Members’ and veterans’ perceptions of the effectiveness and safety of cranial electrotherapy stimulation (CES) for anxiety, PTSD, insomnia, depression, pain, and headache.

Design
Email addresses for potential participants were obtained from prescriptions for Alpha-Stim CES devices written by DOD or VA practitioners that were on file at Electromedical Products International, Inc., Mineral Wells, Texas, the manufacturer of the device. Service members and veterans (N=1,514) who had obtained an Alpha-Stim CES device through the Department of Defense or Veterans Affairs Medical Center from 2006-2011 were invited to participate in the web-based survey via email. No study blinding was reported.

Primary Outcome Measures
Perceptions of the effectiveness and safety of CES using an online survey for:

  • Anxiety
  • Depression
  • Insomnia
  • Pain
  • Headache
  • PTSD

Secondary Outcome Measures
Perceived effectiveness of survey respondents who were taking prescription medications for their condition and those that used CES only using an online survey.

Key Inclusion Criteria
Using an Alpha-Stim CES devices written by DOD or VA practitioners that were on file at Electromedical Products International, Inc., Mineral Wells, Texas, the manufacturer of the device.

Key Exclusion Criteria
None reported.

Protocol Summary
Service members and veterans who had obtained an Alpha-Stim CES device through the Department of Defense or Veterans Affairs Medical Center from 2006-2011 were invited to participate in the web-based survey.

Device Application Protocol
The survey responders were expected to have used the Alpha-Stim device as per the recommendations of their medical provider when reporting their perceptions of the effectiveness and safety of CES for anxiety, PTSD, insomnia, depression, pain, and headache

Statistical Analysis Plan
No apriori hypothesis were formally reported as this was a non-probability, purposive sampling survey study was to examine Service Members’ and veterans’ perceptions of the effectiveness and safety of CES for anxiety, PTSD, insomnia, depression, pain, and headache. A seven-point Likert scale, which has established validity in the literature, was used to measure respondents’ perceived effectiveness of CES for anxiety, PTSD, insomnia, and depression. The choices on the Likert scale were:

  • Worse (negative change)
  • No change (0%)
  • Slight improvement (1% to 24%)
  • Fair improvement (25% to 49%)
  • Moderate improvement (50% to 74%)
  • Marked improvement (75% to 99%)
  • Complete recovery (100%)

Results

Subjects
Service members and veterans (N=1,514) were invited to participate in the web-based survey via email. One hundred fifty-two participants (152) returned questionnaires. Seven (7) questionnaires did not include any effectiveness and safety data. Thus, the valid sample size was N=145 for the analysis of the effectiveness and safety questions. All participants used CES at home following a DOD or VA CES protocol.

Perceived improvement of anxiety from CES by group.

Seventy-two percent (72%) of respondents were active-duty service members and 28% were veterans. The sample was 75% male. Subjects ranged in age from 19-67 years with a mean of 38 years. Eighty-two percent (82%) were still using Alpha-Stim CES. Seventy-three percent (73%) were currently taking at least one prescription drug for their condition. The length of time respondents reported using Alpha-Stim ranged from three months to three years. The median length of time respondents used Alpha-Stim CES was nine months.

Service members’ and veterans’ perceived effectiveness of Alpha-Stim for anxiety, insomnia, and depression.

Effectiveness of Alpha-Stim CES
Anxiety (N=114). Of the total group, 46.5% reported less anxiety and clinical improvement of ≥ 50% while 20.2% reported clinical improvement of anxiety between 25-49%. In the total group, 66.7% respondents reported ≥ 25% improvement in anxiety. In the CES only group (no medications), 57.7% reported decreased anxiety and clinical improvement of ≥ 50% while 15.4% reported clinical improvement of anxiety between 25-49% for a total of 73.1% of respondents who reported less anxiety and clinical improvement ≥ 25%. In the CES and medications group, 43.2% of respondents reported decreased anxiety and clinical improvement ≥ 50% while 21.6% reported decreased anxiety 25-49% improvement for a total of 64.8% of respondents who reported decreased anxiety and clinical improvement ≥ 25%.

PTSD (N=88). Of the total group, 38.6% reported less anxiety and clinical improvement of ≥ 50% while 23.9% reported clinical improvement of anxiety between 25-49%. In the total group, 62.5% respondents reported ≥ 25% improvement in anxiety. In the CES only group (no medications), 50.0% reported decreased anxiety and clinical improvement of ≥ 50% while 22.2% reported clinical improvement of anxiety between 25-49% for a total of 72.2% of respondents who reported less anxiety and clinical improvement ≥ 25%. In the CES and medications group, 35.7% of respondents reported decreased anxiety and clinical improvement ≥ 50% while 24.3% reported decreased anxiety 25-49% improvement for a total of 60.0% of respondents who reported decreased anxiety and clinical improvement ≥ 25%.

Insomnia (N=98). Between 25-49% for a total of 85.8% of respondents who reported less insomnia and clinical improvement ≥25%. In the CES and medications group, 40.3% of respondents reported decreased insomnia and clinical improvement ≥50% while 19.5% reported decreased insomnia of 25-49% improvement for a total of 59.8% of respondents who reported decreased insomnia and clinical improvement ≥25%.

Headache. The most striking finding was that 100% of those respondents who were using Alpha-Stim for headache reported improvement of ≥25% and 64.7% of these respondents reported improvement of ≥50%.

Safety of Alpha-Stim CES
Ninety-nine percent (99%) of subjects in this survey considered CES technology to be safe. Ninety-nine percent (99%) of participants did not report any problems related to using CES self-directed at home following a DOD or VA CES Protocol. One respondent reported not being shown how to use the CES device properly.

Conclusions
Service members and veterans perceived CES as a safe and effective treatment for anxiety, PTSD, insomnia, depression, pain, and headache when used either as an adjunct to pharmaceutical therapy or as a stand-alone therapy. In addition, the findings support that service members and veterans can successfully use self-directed CES at home following a DOD or VA CES protocol.

Limitations
The survey was a non-probability, purposive sampling survey asking participants to retrospectively report their perceptions of the effectiveness and safety of CES for anxiety, PTSD, insomnia, depression, pain and headache.

Study Quality: FAIR