AnxietyNCT05887713
Novel Mental Health Therapies to Improve Military Readiness
A study testing Experimental: Alpha-Stim 100 in people with Anxiety and Alpha Stim, run by David Moss at 1 site in United States.
Trial summary
To evaluate the efficacy of CES as a therapy to treat and mitigate symptoms of generalized anxiety in DoD beneficiaries in a prospective clinical trial and compare this to sham (placebo) CES. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Alpha Stim, Cranial Electrotherapy Stimulation
- What is being tested?
- Experimental: Alpha-Stim 100
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active Duty and DoD Beneficiaries aged 18 or older
- Threshold Generalized Anxiety symptoms based on MINI scoring and GAD-7 score of 10 or higher
Who cannot join
- Bi-polar disorder, schizophrenia or schizoaffective disorders, manic depressive disorder, autism spectrum disorders, binge eating disorder, anorexia nervosa, bulimia, obsessive compulsive disorder, gender dysphoria (transgender is not an exclusion unless subject meets DSM-5 criteria for gender dysphoria), dementia, mental or other health disorders that prevent subjects from adhering to treatment.This will be verified by patient report or by chart review.
- Subjects taking anti-psychotic medications including but not limited to; risperidone, quetiapine, olanzapine, ziprasidone, paliperidone, aripiprazole and clozapine.
- Subjects taking any seizure medications (ex: Dilantin)
- Subjects who use nicotine in any form: Cigarettes, Vape pens, chewing tobacco, tobacco pouches, patches, gum.
- Subjects with medical implant devices such as pacemakers or any device contraindicated for CES treatment.
- Subjects who have started, altered, or discontinued use of any anti-depressant or anxiolytic in the past four weeks (including any medication in the following classes; selective serotonin reuptake inhibitors [SSRI], serotonin and norepinephrine reuptake inhibitors [SnRI], Wellbutrin, beta blockers specifically taken for anxiety, monoamine oxidase inhibitors [MAOI], tricyclic antidepressants [TCA], benzodiazepenes).
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- Pregnancy
- Current or previous use of a CES device.
- Experimental or clinical brain stimulation such as deep brain stimulation or transcranial magnetic stimulation for any indication (current or past 3 months).
- Psychotherapy for anxiety based on exposure therapy (current or past 6 weeks)
- Seizure disorder (current or history). History of febrile childhood seizures is allowed.
- Higher than low suicide risk on the Columbia Suicide Severity Rating Scale (CSSRS).
- Known cardiac arrythmias
- Anything that would make participation in the study unsafe or medically unadvisable in the assessment of a study clinician.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, 89191
About this study
To evaluate the efficacy of CES as a therapy to treat and mitigate symptoms of generalized anxiety in DoD beneficiaries in a prospective clinical trial and compare this to sham (placebo) CES.
Read the detailed description
Anxiety disorders are diverse. The Veterans Administration diagnostic code options for anxiety are Post-Traumatic Stress Disorder (PTSD), Generalized Anxiety Disorder (GAD), obsessive- compulsive disorder (OCD), Other Specified Anxiety Disorder, phobias and Social Anxiety Disorder, and panic disorder and/or agoraphobia. In the US Military, anxiety disorders are increasing in prevalence.
According to one DoD report, by 2012 anxiety disorders made up more medical encounters than any other mental disorder and was fourth in overall encounter categories including non-mental health related injuries and illnesses (Anxiety Disorders Active Component).
Traditional mental health therapies and active-duty military readiness are often mutually exclusive due to habit-forming and significant physical and mental adverse side effects resulting from standard mental health therapies. In veterans, while work readiness is less of an issue, traditional mental health therapies affect activities of daily living and overall quality of life.
Nonpharmacological approaches to mental health therapy in the military health system are therefore relevant and timely (Bravo).
Cranial Electrotherapy Stimulation (CES): Also known by the proprietary name Alpha-Stim, cranial electrotherapy stimulation is a noninvasive neuromodulation treatment commonly used to mitigate anxiety, posttraumatic stress, insomnia, and depression. The device is FDA cleared for the treatment of anxiety, insomnia, depression, and acute post-traumatic and chronic pain.
Active duty servicemembers and veterans using the device reported at least 50% improvement in each area (Kirsch). Newer cranial electrotherapy stimulation devices that attach to the patients' ears significantly improved general and state-anxiety (Kim, Morriss). Set up of alpha stim is demonstrated at the following website; https://youtu.be/ImDQ2HWAS6U
Cognitive behavioral therapy is a form of talk therapy shown to be effective for GAD. While its effectiveness is proven, it requires referral to a trained counselor or therapist, requires multiple visits and can cause patients to miss work or other events (Borza). Brief CBT is a specific method of CBT that consists of 1. psychoeducation on the Cognitive Behavioral Model 2.
assessment of frequency and severity of symptoms, as well as desired cognitive and behavioral change (ie goal setting) 3. Practice developing insight and cognitive disputation using the Antecedents, Behavior, Consequences (ABC) Model 4) Review subjects' homework (Thought Record) and reinforce cognitive disputation of unhelpful thinking patterns during appointments (Cully).
There are multiple screening/diagnostic scales to determine the presence and severity of GAD. The Mini International Neuropsychiatric Interview is a validated clinician administered brief structured interview for multiple major psychiatric disorders including anxiety (Sheehan). The Beck Anxiety Inventory (BAI) is a 21 item self-report and addresses comprehensive symptoms of anxiety.
This tool specifically can be used to monitor symptoms over time (Beck). The Hamilton Anxiety Rating Scale (HAM-A) is a 14-item validated clinician administered questionnaire that measures the severity of both psychic and somatic anxiety symptoms (Hamilton).
Heart Rate Variability (HRV) has been used as a surrogate marker for autonomic function
/balance. Low HRV correlates with increased sympathetic tone and studies indicate that patients with depression and anxiety disorders may have abnormally low HRV compared to controls (Servant).
This study will utilize the Firstbeat Bodyguard 2, a device designed to act as a professional grade sensor of short and long term HRV measurements. As a non medical device, it does not require FDA clearance.
Vagal efficiency is measured by the slope of the linear regression between heart rate and HRV. It represents the change in heart rate per unit increase/decrease in HRV. Clinically it is theorized that it measures the ability of the parasympathetic nervous system to adapt to dynamic changes in sympathetic tone (Kovacic).
This study will evaluate the efficacy of CES as a therapy to treat and mitigate symptoms of generalized anxiety in DoD beneficiaries in a prospective clinical trial and compare this to sham (placebo) CES.
- Conditions
- Anxiety, Alpha Stim, Cranial Electrotherapy Stimulation, Cognitive Behavioral Therapy, Heart Rate Variability
- Being tested
- Experimental: Alpha-Stim 100, Sham Comparator
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Alpha-Stim 100Device
Subjects in CES intervention group will run CES at home daily for 6 weeks. Study staff will call weekly to ensure adherence to CES treatment, gather CES usage data for the week and to answer any questions.
Sham ComparatorDevice
Subjects in CES sham group will run sham CES at home daily for 6 weeks. Study staff will call weekly to ensure adherence to sham CES treatment, gather sham CES usage data for the week and to answer any questions.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Active CES | Experimental | Active CES treatment at home 40 minutes daily for 6 weeks Receives: Device: Experimental: Alpha-Stim 100 |
| Group 2: Sham CES | Sham comparator | Sham CES treatment at home 40 minutes daily for 6 weeks Receives: Device: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Inventory (BAI)
BAI total scores range from 0 to 63; higher total scores indicate more severe anxiety symptoms.
Scores are clinically categorized as 0-7 (minimal anxiety) 8-15 (mild anxiety), 16-25 (moderate anxiety), and 26-63 (severe anxiety). The BAI and HAM-A are mildly correlated. BAI will be treated as normally distributed allowing parametric statistical methods to be used.
Baseline BAI will be obtained.
Measured: Visit 1 (Week 0)
Beck Anxiety Inventory (BAI)
BAI total scores range from 0 to 63; higher total scores indicate more severe anxiety symptoms.
Scores are clinically categorized as 0-7 (minimal anxiety) 8-15 (mild anxiety), 16-25 (moderate anxiety), and 26-63 (severe anxiety). The BAI and HAM-A are mildly correlated. BAI will be treated as normally distributed allowing parametric statistical methods to be used.
BAI will be obtained.
Measured: Visit 8 (Week 10)
Hamilton Anxiety Rating Scale (HAM-A)
HAM-A total scores range from 0 to 56. Scores are clinically categorized as 17 or less (mild anxiety), 18-24 (moderate anxiety), and 25-30 (severe anxiety). HAM-A will be treated as normally distributed allowing parametric statistical methods to be used.
Baseline HAM-A will be obtained.
Measured: Visit 1 (Week 0)
Hamilton Anxiety Rating Scale (HAM-A)
HAM-A total scores range from 0 to 56. Scores are clinically categorized as 17 or less (mild anxiety), 18-24 (moderate anxiety), and 25-30 (severe anxiety). HAM-A will be treated as normally distributed allowing parametric statistical methods to be used.
HAM-A will be obtained.
Measured: Visit 8 (Week 10)
Heart Rate Variability (HRV)
Heart Rate Variability (HRV) time domain measures estimate the statistical variability of interbeat intervals.
HRV will be obtained using the First Beat Bodyguard 2. Subjects will have the device placed according to the manufacturer's instructions on the torso. HRV will be captured for 2 minutes in a seated position, then 2 minutes in a standing position, then 2 minutes in a seated position. HRV, and vagal efficiency will be calculated using this data. Subjects will be instructed not to consume caffeine, alcohol or nicotine containing products within 12 hours of HRV data collection. Subjects will be told not to take anti-cholinergic medications (ex: antihistamines), central nervous system depressants or central nervous system stimulant medications within 24 hours of HRV measurement. (Based on literature review, alcohol, caffeine and nicotine are excreted completely within 12 hours and the majority of medications listed are excreted within 24-48 hours.)
Measured: Visit 1 (Week 0)
Heart Rate Variability (HRV)
Heart Rate Variability (HRV) time domain measures estimate the statistical variability of interbeat intervals.
HRV will be obtained using the First Beat Bodyguard 2. Subjects will have the device placed according to the manufacturer's instructions on the torso. HRV will be captured for 2 minutes in a seated position, then 2 minutes in a standing position, then 2 minutes in a seated position. HRV, and vagal efficiency will be calculated using this data. Subjects will be instructed not to consume caffeine, alcohol or nicotine containing products within 12 hours of HRV data collection. Subjects will be told not to take anti-cholinergic medications (ex: antihistamines), central nervous system depressants or central nervous system stimulant medications within 24 hours of HRV measurement. (Based on literature review, alcohol, caffeine and nicotine are excreted completely within 12 hours and the majority of medications listed are excreted within 24-48 hours.)
Measured: Visit 8 (Week 10)
Vagal Efficiency (VE)
Vagal efficiency (VE) mean (SD) in a sample having a history of maltreatment were 61.7(19.5) and in a sample without a history of maltreatment were 69.6 (25.5). VE will be treated as normally distributed allowing parametric statistical methods to be used.
Vagal efficiency is measured by the slope of the linear regression between heart rate and HRV. It represents the change in heart rate per unit increase/decrease in HRV. Clinically it is theorized that it measures the ability of the parasympathetic nervous system to adapt to dynamic changes in sympathetic tone.
Measured: Visit 1 (Week 0)
Vagal Efficiency (VE)
Vagal efficiency (VE) mean (SD) in a sample having a history of maltreatment were 61.7(19.5) and in a sample without a history of maltreatment were 69.6 (25.5). VE will be treated as normally distributed allowing parametric statistical methods to be used.
Vagal efficiency is measured by the slope of the linear regression between heart rate and HRV. It represents the change in heart rate per unit increase/decrease in HRV. Clinically it is theorized that it measures the ability of the parasympathetic nervous system to adapt to dynamic changes in sympathetic tone
Measured: Visit 8 (Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Moss
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, David Moss, Mike O'Callaghan Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887713
- Sponsor's protocol ID
- alpha stim
- Status last verified
- Aug 2026
- First submitted
- 24 May 2023
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We do not plan on sharing data
Publications
Anxiety Disorders, Active Component, U.S. Armed Forces, 2000-2012. October 2013 Vol. 20 No. 10M S M R. https://deploymentpsych.org/system/files/member_resource /2013_MSMR_Anxiety_Disorders_Active_Component_US_Armed_Forces_2000-2012.pdf
Bravo AJ, Witkiewitz K, Kelley ML, Redman JC. Prevalence of Mental Health Problems and Willingness to Participate in a Mindfulness Treatment: An Examination among Veterans Injured in Combat. Mindfulness (N Y). 2019 May;10(5):953-963. doi: 10.1007/s12671-018-1047-4. Epub 2018 Nov 10.
PubMed 31131067Kirsch DL, Price LR, Nichols F, Marksberry JA, Platoni KT. Military service member and veteran self reports of efficacy of cranial electrotherapy stimulation for anxiety, posttraumatic stress disorder, insomnia, and depression. US Army Med Dep J. 2014 Oct-Dec:46-54.
PubMed 25830798Kim J, Kim H, Kim DH, Lee SK, Roh JY, Kim CH, Chang JG, Roh D. Effects of cranial electrotherapy stimulation with novel in-ear electrodes on anxiety and resting-state brain activity: A randomized double-blind placebo-controlled trial. J Affect Disord. 2021 Dec 1;295:856-864. doi: 10.1016/j.jad.2021.08.141. Epub 2021 Sep 3.
PubMed 34706456Borza L. Cognitive-behavioral therapy for generalized anxiety. Dialogues Clin Neurosci. 2017 Jun;19(2):203-208. doi: 10.31887/DCNS.2017.19.2/lborza.
PubMed 28867944Cully, J.A., Dawson, D.B., Hamer, J., & Tharp, A.L. 2020. A Provider's Guide to Brief Cognitive Behavioral Therapy. Department of Veterans Affairs South Central MIRECC, Houston, TX
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
PubMed 9881538Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
PubMed 3204199HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.
PubMed 13638508Servant D, Logier R, Mouster Y, Goudemand M. [Heart rate variability. Applications in psychiatry]. Encephale. 2009 Oct;35(5):423-8. doi: 10.1016/j.encep.2008.06.016. Epub 2008 Dec 18. French.
PubMed 19853714Kovacic K, Kolacz J, Lewis GF, Porges SW. Impaired Vagal Efficiency Predicts Auricular Neurostimulation Response in Adolescent Functional Abdominal Pain Disorders. Am J Gastroenterol. 2020 Sep;115(9):1534-1538. doi: 10.14309/ajg.0000000000000753.
PubMed 32732620
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Mental Health Therapies to Improve Military Readiness
- ClinicalTrials.gov ID
- NCT05887713
- Acronym / sponsor ID
- alpha stim
- Conditions
- Anxiety, Alpha Stim, Cranial Electrotherapy Stimulation, Cognitive Behavioral Therapy, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- David MossUS federal agency
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of CES as a therapy to treat and mitigate symptoms of generalized anxiety in DoD beneficiaries in a prospective clinical trial and compare this to sham (placebo) CES.
Detailed description
Anxiety disorders are diverse. The Veterans Administration diagnostic code options for anxiety are Post-Traumatic Stress Disorder (PTSD), Generalized Anxiety Disorder (GAD), obsessive- compulsive disorder (OCD), Other Specified Anxiety Disorder, phobias and Social Anxiety Disorder, and panic disorder and/or agoraphobia. In the US Military, anxiety disorders are increasing in prevalence.
According to one DoD report, by 2012 anxiety disorders made up more medical encounters than any other mental disorder and was fourth in overall encounter categories including non-mental health related injuries and illnesses (Anxiety Disorders Active Component).
Traditional mental health therapies and active-duty military readiness are often mutually exclusive due to habit-forming and significant physical and mental adverse side effects resulting from standard mental health therapies. In veterans, while work readiness is less of an issue, traditional mental health therapies affect activities of daily living and overall quality of life.
Nonpharmacological approaches to mental health therapy in the military health system are therefore relevant and timely (Bravo).
Cranial Electrotherapy Stimulation (CES): Also known by the proprietary name Alpha-Stim, cranial electrotherapy stimulation is a noninvasive neuromodulation treatment commonly used to mitigate anxiety, posttraumatic stress, insomnia, and depression. The device is FDA cleared for the treatment of anxiety, insomnia, depression, and acute post-traumatic and chronic pain.
Active duty servicemembers and veterans using the device reported at least 50% improvement in each area (Kirsch). Newer cranial electrotherapy stimulation devices that attach to the patients' ears significantly improved general and state-anxiety (Kim, Morriss). Set up of alpha stim is demonstrated at the following website; https://youtu.be/ImDQ2HWAS6U
Cognitive behavioral therapy is a form of talk therapy shown to be effective for GAD. While its effectiveness is proven, it requires referral to a trained counselor or therapist, requires multiple visits and can cause patients to miss work or other events (Borza). Brief CBT is a specific method of CBT that consists of 1. psychoeducation on the Cognitive Behavioral Model 2.
assessment of frequency and severity of symptoms, as well as desired cognitive and behavioral change (ie goal setting) 3. Practice developing insight and cognitive disputation using the Antecedents, Behavior, Consequences (ABC) Model 4) Review subjects' homework (Thought Record) and reinforce cognitive disputation of unhelpful thinking patterns during appointments (Cully).
There are multiple screening/diagnostic scales to determine the presence and severity of GAD. The Mini International Neuropsychiatric Interview is a validated clinician administered brief structured interview for multiple major psychiatric disorders including anxiety (Sheehan). The Beck Anxiety Inventory (BAI) is a 21 item self-report and addresses comprehensive symptoms of anxiety.
This tool specifically can be used to monitor symptoms over time (Beck). The Hamilton Anxiety Rating Scale (HAM-A) is a 14-item validated clinician administered questionnaire that measures the severity of both psychic and somatic anxiety symptoms (Hamilton).
Heart Rate Variability (HRV) has been used as a surrogate marker for autonomic function
/balance. Low HRV correlates with increased sympathetic tone and studies indicate that patients with depression and anxiety disorders may have abnormally low HRV compared to controls (Servant).
This study will utilize the Firstbeat Bodyguard 2, a device designed to act as a professional grade sensor of short and long term HRV measurements. As a non medical device, it does not require FDA clearance.
Vagal efficiency is measured by the slope of the linear regression between heart rate and HRV. It represents the change in heart rate per unit increase/decrease in HRV. Clinically it is theorized that it measures the ability of the parasympathetic nervous system to adapt to dynamic changes in sympathetic tone (Kovacic).
This study will evaluate the efficacy of CES as a therapy to treat and mitigate symptoms of generalized anxiety in DoD beneficiaries in a prospective clinical trial and compare this to sham (placebo) CES.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Active CES | Experimental | Device: Experimental: Alpha-Stim 100Active CES treatment at home 40 minutes daily for 6 weeks |
| Group 2: Sham CES | Sham comparator | Device: Sham ComparatorSham CES treatment at home 40 minutes daily for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Active Duty and DoD Beneficiaries aged 18 or older
- Threshold Generalized Anxiety symptoms based on MINI scoring and GAD-7 score of 10 or higher
Key exclusion criteria (14 listed)
- Bi-polar disorder, schizophrenia or schizoaffective disorders, manic depressive disorder, autism spectrum disorders, binge eating disorder, anorexia nervosa, bulimia, obsessive compulsive disorder, gender dysphoria (transgender is not an exclusion unless subject meets DSM-5 criteria for gender dysphoria), dementia, mental or other health disorders that prevent subjects from adhering to treatment.This will be verified by patient report or by chart review.
- Subjects taking anti-psychotic medications including but not limited to; risperidone, quetiapine, olanzapine, ziprasidone, paliperidone, aripiprazole and clozapine.
- Subjects taking any seizure medications (ex: Dilantin)
- Subjects who use nicotine in any form: Cigarettes, Vape pens, chewing tobacco, tobacco pouches, patches, gum.
- Subjects with medical implant devices such as pacemakers or any device contraindicated for CES treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Alpha-Stim 100Subjects in CES intervention group will run CES at home daily for 6 weeks. Study staff will call weekly to ensure adherence to CES treatment, gather CES usage data for the week and to answer any questions. | Device | Group 1: Active CES |
| Sham ComparatorSubjects in CES sham group will run sham CES at home daily for 6 weeks. Study staff will call weekly to ensure adherence to sham CES treatment, gather sham CES usage data for the week and to answer any questions. | Device | Group 2: Sham CES |
Primary outcome
Beck Anxiety Inventory (BAI)
Time frame: Visit 1 (Week 0)
BAI total scores range from 0 to 63; higher total scores indicate more severe anxiety symptoms. Scores are clinically categorized as 0-7 (minimal anxiety) 8-15 (mild anxiety), 16-25 (moderate anxiety), and 26-63 (severe anxiety). The BAI and HAM-A are mildly correlated. BAI will be treated as normally distributed allowing parametric statistical methods to be used. Baseline BAI will be obtained.
Beck Anxiety Inventory (BAI)
Time frame: Visit 8 (Week 10)
BAI total scores range from 0 to 63; higher total scores indicate more severe anxiety symptoms. Scores are clinically categorized as 0-7 (minimal anxiety) 8-15 (mild anxiety), 16-25 (moderate anxiety), and 26-63 (severe anxiety). The BAI and HAM-A are mildly correlated. BAI will be treated as normally distributed allowing parametric statistical methods to be used. BAI will be obtained.
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Visit 1 (Week 0)
HAM-A total scores range from 0 to 56. Scores are clinically categorized as 17 or less (mild anxiety), 18-24 (moderate anxiety), and 25-30 (severe anxiety). HAM-A will be treated as normally distributed allowing parametric statistical methods to be used. Baseline HAM-A will be obtained.
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Visit 8 (Week 10)
HAM-A total scores range from 0 to 56. Scores are clinically categorized as 17 or less (mild anxiety), 18-24 (moderate anxiety), and 25-30 (severe anxiety). HAM-A will be treated as normally distributed allowing parametric statistical methods to be used. HAM-A will be obtained.
Heart Rate Variability (HRV)
Time frame: Visit 1 (Week 0)
Heart Rate Variability (HRV) time domain measures estimate the statistical variability of interbeat intervals. HRV will be obtained using the First Beat Bodyguard 2. Subjects will have the device placed according to the manufacturer's instructions on the torso. HRV will be captured for 2 minutes in a seated position, then 2 minutes in a standing position, then 2 minutes in a seated position. HRV, and vagal efficiency will be calculated using this data. Subjects will be instructed not to consume caffeine, alcohol or nicotine containing products within 12 hours of HRV data collection. Subjects will be told not to take anti-cholinergic medications (ex: antihistamines), central nervous system depressants or central nervous system stimulant medications within 24 hours of HRV measurement. (Based on literature review, alcohol, caffeine and nicotine are excreted completely within 12 hours and the majority of medications listed are excreted within 24-48 hours.)
Heart Rate Variability (HRV)
Time frame: Visit 8 (Week 10)
Heart Rate Variability (HRV) time domain measures estimate the statistical variability of interbeat intervals. HRV will be obtained using the First Beat Bodyguard 2. Subjects will have the device placed according to the manufacturer's instructions on the torso. HRV will be captured for 2 minutes in a seated position, then 2 minutes in a standing position, then 2 minutes in a seated position. HRV, and vagal efficiency will be calculated using this data. Subjects will be instructed not to consume caffeine, alcohol or nicotine containing products within 12 hours of HRV data collection. Subjects will be told not to take anti-cholinergic medications (ex: antihistamines), central nervous system depressants or central nervous system stimulant medications within 24 hours of HRV measurement. (Based on literature review, alcohol, caffeine and nicotine are excreted completely within 12 hours and the majority of medications listed are excreted within 24-48 hours.)
Vagal Efficiency (VE)
Time frame: Visit 1 (Week 0)
Vagal efficiency (VE) mean (SD) in a sample having a history of maltreatment were 61.7(19.5) and in a sample without a history of maltreatment were 69.6 (25.5). VE will be treated as normally distributed allowing parametric statistical methods to be used. Vagal efficiency is measured by the slope of the linear regression between heart rate and HRV. It represents the change in heart rate per unit increase/decrease in HRV. Clinically it is theorized that it measures the ability of the parasympathetic nervous system to adapt to dynamic changes in sympathetic tone.
Vagal Efficiency (VE)
Time frame: Visit 8 (Week 10)
Vagal efficiency (VE) mean (SD) in a sample having a history of maltreatment were 61.7(19.5) and in a sample without a history of maltreatment were 69.6 (25.5). VE will be treated as normally distributed allowing parametric statistical methods to be used. Vagal efficiency is measured by the slope of the linear regression between heart rate and HRV. It represents the change in heart rate per unit increase/decrease in HRV. Clinically it is theorized that it measures the ability of the parasympathetic nervous system to adapt to dynamic changes in sympathetic tone
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- BackgroundAnxiety Disorders, Active Component, U.S. Armed Forces, 2000-2012. October 2013 Vol. 20 No. 10M S M R. https://deploymentpsych.org/system/files/member_resource /2013_MSMR_Anxiety_Disorders_Active_Component_US_Armed_Forces_2000-2012.pdf
- Background: PubMed 31131067Bravo AJ, Witkiewitz K, Kelley ML, Redman JC. Prevalence of Mental Health Problems and Willingness to Participate in a Mindfulness Treatment: An Examination among Veterans Injured in Combat. Mindfulness (N Y). 2019 May;10(5):953-963. doi: 10.1007/s12671-018-1047-4. Epub 2018 Nov 10.
- Background: PubMed 25830798Kirsch DL, Price LR, Nichols F, Marksberry JA, Platoni KT. Military service member and veteran self reports of efficacy of cranial electrotherapy stimulation for anxiety, posttraumatic stress disorder, insomnia, and depression. US Army Med Dep J. 2014 Oct-Dec:46-54.
- Background: PubMed 34706456Kim J, Kim H, Kim DH, Lee SK, Roh JY, Kim CH, Chang JG, Roh D. Effects of cranial electrotherapy stimulation with novel in-ear electrodes on anxiety and resting-state brain activity: A randomized double-blind placebo-controlled trial. J Affect Disord. 2021 Dec 1;295:856-864. doi: 10.1016/j.jad.2021.08.141. Epub 2021 Sep 3.
- Background: PubMed 28867944Borza L. Cognitive-behavioral therapy for generalized anxiety. Dialogues Clin Neurosci. 2017 Jun;19(2):203-208. doi: 10.31887/DCNS.2017.19.2/lborza.
- BackgroundCully, J.A., Dawson, D.B., Hamer, J., & Tharp, A.L. 2020. A Provider's Guide to Brief Cognitive Behavioral Therapy. Department of Veterans Affairs South Central MIRECC, Houston, TX
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- Individual participant dataSharing planned: No. We do not plan on sharing data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Alpha-Stim 100 in people with Anxiety and Alpha Stim, run by David Moss at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Anxiety Inventory (BAI) (time frame: Visit 1 (Week 0)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05887713, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.