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Cranial Electrotherapy Stimulation and Acute Stress

Cranial Electrotherapy Stimulation (CES) Influences on Acute Stress Responses

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06034496
Enrollment
76
Registered
2023-09-13
Start date
2023-09-12
Completion date
2024-11-14
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety State

Keywords

Cranial Electrotherapy Stimulation, Acute Stress

Brief summary

The goal of this study is to quantify the effects of 20 sessions of Cranial Electrotherapy Stimulation (CES) on measures of acute stress responses in Soldiers. The main question it aims to answer is how 20 sessions of CES will affect Soldiers' biochemical (salivary alpha amylase and cortisol), physiological (e.g., heart rate, heart rate variability, respiration rate), emotional (state anxiety), and behavioral (i.e., cognitive task performance) responses. * On Day 1, participants will complete a baseline measure assessing their biochemical, physiological, emotional, and behavioral responses to a stressful lethal force decision making task. * In the next four to six weeks, participants will complete 20 CES sessions. * Within five days of completing the 20 CES sessions, participants will complete a follow-up measure assessing their biochemical, physiological, emotional, and behavioral responses to the same stressful lethal force decision making task they completed on Day 1. Researchers will compare the Active CES group to the Sham CES group to see how 20 sessions of Active CES will affect the participants responses to their biochemical, physiological, emotional and behavioral responses relative to the Sham CES group.

Interventions

Active CES group will receive a minimum of 250µA and up to 500µA depending on thresholding, once daily for 20 days (over the course of 4\ 6 weeks), 20 minutes per day.

DEVICESham CES

Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current

Sponsors

United States Department of Defense
CollaboratorFED
Tufts University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

Coded devices with master key kept outside of research team.

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 18-40 years of age (17-40 if emancipated minor) * Can sit and stand freely. * Have not used or experienced CES administration in the past. * Agree to have their data stored in a repository (database) for future use.

Exclusion criteria

* Use of prescription medications, other than oral contraceptives * Women only: 1. Pregnant or plan to become pregnant during the study 2. Nursing * History of: 1. A neurological or psychological disorder (such as depression, anxiety disorders, migraines, cluster headaches, seizures, Post-traumatic stress disorder (PTSD) or panic attacks). 2. Cardiac disease (including arrhythmia or fast or skipped heart beats). 3. Implanted medical devices, such as pacemakers. 4. Hypertension. 5. Insomnia 6. Head injury (including neurosurgery, concussion, TBI, skull fracture, hematoma) 7. Illness that caused brain injury 8. Any other brain-related condition (such as traumatic brain injury) 9. Metal in the head (outside of mouth, such as shrapnel, surgical clips, or fragments from welding or metalwork) 10. Implanted medical device (e.g., pacemaker, insulin pump)

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in Heart Rate During Stressful Lethal Force Decision Making TaskBaseline and follow-up session after 20 CES to be completed within 4-6weeksheart rate will be measured in beats per minute.
Change From Baseline in Respiration Rate During Stressful Lethal Force Decision Making TaskBaseline and follow-up session after 20 CES to be completed within 4-6weeksrespiration rate will be measured in breaths per minute.
Change From Baseline in Heart Rate Variability During Stressful Lethal Force Decision Making TaskBaseline and follow-up session after 20 CES to be completed within 4-6weeksHeart rate variability will be measured in RMSSD.
Change Over Time in Cortisol During Stressful Lethal Force Decision Making TaskBaseline and follow-up session after 20 CES completed within 4-6weeksCortisol (µg/dL) will be measured through saliva samples. Saliva samples will be taken at five time points, approximately 20 minute increments during the baseline and follow-up sessions.
Change Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskBaseline and follow-up session after 20 CES completed within 4-6weeksAlpha amylase (IU) will be measured through saliva samples. Saliva samples will be taken at five time points, approximately 20 minute increments during the baseline and follow-up sessions.
Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upAt baseline, at each of the 20 CES sessions completed within 4-6weeks, and at follow-up to be completed within 5 days of last CESSTAI assesses both state and trait anxiety separately with each scale ranging from 20 to 80, with higher scores correlating with greater anxiety. STAI-S is the State Trait Anxiety Inventory - State version, and STAI-T is the State Trait Anxiety Inventory - Trait version.
Change From Baseline in Recognition MemoryBaseline and follow-up session after 20 CES completed within 4-6weeksRecognition memory of previously learned targets while ignoring visually similar distractor objects will be measured and evaluated with percent accuracy.
Change From Baseline in Spatial OrientationBaseline and follow-up session after 20 CES completed within 4-6weeksSpatial orientation task will involve pointing towards a series of distant (out of visible range) landmarks in the virtual environment and estimating distance to those landmarks. Spatial orientation will be calculated using mean absolute angular error. Larger numbers correlate with higher error.
Change From Baseline in Decision Making AccuracyBaseline and follow-up session after 20 CES completed within 4-6weeksParticipants will make lethal force decision making by shooting at threatening targets and allowing non-threatening targets to pass. Decision making accuracy will be calculated using d prime. Higher d prime correlates with better accuracy.
Change From Baseline in Decision Making Reaction TimeBaseline and follow-up session after 20 CES completed within 4-6weeksParticipants will make lethal force decision making by shooting at threatening targets and allowing non-threatening targets to pass. Decision making reaction time to shoot at threatening targets will be measured in milliseconds.

Countries

United States

Participant flow

Pre-assignment details

76 participants consented to participate in the study. However, 18 participants (soldiers) were unable to start the study due to scheduling conflicts. Therefore, only 58 are included in the Participant Flow.

Participants by arm

ArmCount
Active CES
Active Cranial Electrotherapy Stimulation (CES) Active CES: Active CES group will receive a minimum of 250µA and up to 500µA depending on thresholding, once daily for 20 days (over the course of 4\ 6 weeks), 20 minutes per day.
21
Sham CES
Sham Cranial Electrotherapy Stimulation (CES) Sham CES: Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current
25
Total46

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDid not meet minimum stimulation threshold21
Overall StudyWithdrawal by Subject54

Baseline characteristics

CharacteristicSham CESTotalActive CES
Age, Continuous23.36 years
STANDARD_DEVIATION 5.82
22.26 years
STANDARD_DEVIATION 4.83
20.95 years
STANDARD_DEVIATION 2.94
Education14.6 years
STANDARD_DEVIATION 3.04
14.3 years
STANDARD_DEVIATION 2.44
13.95 years
STANDARD_DEVIATION 1.43
Military15 Participants28 Participants13 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants5 Participants3 Participants
Race (NIH/OMB)
Black or African American
1 Participants2 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants3 Participants0 Participants
Race (NIH/OMB)
White
19 Participants36 Participants17 Participants
Region of Enrollment
United States
25 Participants46 Participants21 Participants
Sex: Female, Male
Female
11 Participants17 Participants6 Participants
Sex: Female, Male
Male
14 Participants29 Participants15 Participants
STAI-T29.52 units on a scale
STANDARD_DEVIATION 7.28
31.43 units on a scale
STANDARD_DEVIATION 9.17
33.71 units on a scale
STANDARD_DEVIATION 10.75

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 280 / 30
other
Total, other adverse events
2 / 282 / 30
serious
Total, serious adverse events
0 / 280 / 30

Outcome results

Primary

Change From Baseline in Decision Making Accuracy

Participants will make lethal force decision making by shooting at threatening targets and allowing non-threatening targets to pass. Decision making accuracy will be calculated using d prime. Higher d prime correlates with better accuracy.

Time frame: Baseline and follow-up session after 20 CES completed within 4-6weeks

ArmMeasureGroupValue (MEAN)Dispersion
Active CESChange From Baseline in Decision Making AccuracyBaseline3.64 d primeStandard Deviation 0.681
Active CESChange From Baseline in Decision Making AccuracyFollow-up4.48 d primeStandard Deviation 0.943
Sham CESChange From Baseline in Decision Making AccuracyBaseline3.89 d primeStandard Deviation 1.08
Sham CESChange From Baseline in Decision Making AccuracyFollow-up4.75 d primeStandard Deviation 1.29
p-value: 0.36ANOVA
p-value: 0ANOVA
p-value: 0.96ANOVA
Primary

Change From Baseline in Decision Making Reaction Time

Participants will make lethal force decision making by shooting at threatening targets and allowing non-threatening targets to pass. Decision making reaction time to shoot at threatening targets will be measured in milliseconds.

Time frame: Baseline and follow-up session after 20 CES completed within 4-6weeks

Population: Collected data were invalid and could not be analyzed due to a coding error. The coding error incorrectly summed and aggregated the distances of all avatars on the screen, rather than isolating the distance of the specific avatar that was shot. As a result, we were unable to reverse engineer the output to derive a value that accurately reflected Reaction Times.

Primary

Change From Baseline in Heart Rate During Stressful Lethal Force Decision Making Task

heart rate will be measured in beats per minute.

Time frame: Baseline and follow-up session after 20 CES to be completed within 4-6weeks

Population: Due to technical issues, we were unable to collect data from 9 participants.

ArmMeasureGroupValue (MEAN)Dispersion
Active CESChange From Baseline in Heart Rate During Stressful Lethal Force Decision Making TaskBaseline98.5 bpmStandard Deviation 16.1
Active CESChange From Baseline in Heart Rate During Stressful Lethal Force Decision Making TaskFollow-up100.0 bpmStandard Deviation 13.5
Sham CESChange From Baseline in Heart Rate During Stressful Lethal Force Decision Making TaskBaseline111 bpmStandard Deviation 19.5
Sham CESChange From Baseline in Heart Rate During Stressful Lethal Force Decision Making TaskFollow-up114 bpmStandard Deviation 20.1
p-value: 0.012ANOVA
p-value: 0.33ANOVA
p-value: 0.85ANOVA
Primary

Change From Baseline in Heart Rate Variability During Stressful Lethal Force Decision Making Task

Heart rate variability will be measured in RMSSD.

Time frame: Baseline and follow-up session after 20 CES to be completed within 4-6weeks

ArmMeasureGroupValue (MEAN)Dispersion
Active CESChange From Baseline in Heart Rate Variability During Stressful Lethal Force Decision Making TaskBaseline13.0 bpmStandard Deviation 5.17
Active CESChange From Baseline in Heart Rate Variability During Stressful Lethal Force Decision Making TaskFollow-up12.0 bpmStandard Deviation 4.76
Sham CESChange From Baseline in Heart Rate Variability During Stressful Lethal Force Decision Making TaskBaseline11.2 bpmStandard Deviation 4.53
Sham CESChange From Baseline in Heart Rate Variability During Stressful Lethal Force Decision Making TaskFollow-up10.5 bpmStandard Deviation 4.74
p-value: 0.26ANOVA
p-value: 0.17ANOVA
p-value: 0.73ANOVA
Primary

Change From Baseline in Recognition Memory

Recognition memory of previously learned targets while ignoring visually similar distractor objects will be measured and evaluated with percent accuracy.

Time frame: Baseline and follow-up session after 20 CES completed within 4-6weeks

ArmMeasureGroupValue (MEAN)Dispersion
Active CESChange From Baseline in Recognition MemoryFollow-up78.2 percent accuracyStandard Deviation 15.9
Active CESChange From Baseline in Recognition MemoryBaseline77.1 percent accuracyStandard Deviation 11
Sham CESChange From Baseline in Recognition MemoryBaseline80 percent accuracyStandard Deviation 12.2
Sham CESChange From Baseline in Recognition MemoryFollow-up76.7 percent accuracyStandard Deviation 14.3
p-value: 0.85ANOVA
p-value: 0.69ANOVA
p-value: 0.4ANOVA
Primary

Change From Baseline in Respiration Rate During Stressful Lethal Force Decision Making Task

respiration rate will be measured in breaths per minute.

Time frame: Baseline and follow-up session after 20 CES to be completed within 4-6weeks

ArmMeasureGroupValue (MEAN)Dispersion
Active CESChange From Baseline in Respiration Rate During Stressful Lethal Force Decision Making TaskBaseline16.2 breath per minuteStandard Deviation 3.52
Active CESChange From Baseline in Respiration Rate During Stressful Lethal Force Decision Making TaskFollow-up17.3 breath per minuteStandard Deviation 3.05
Sham CESChange From Baseline in Respiration Rate During Stressful Lethal Force Decision Making TaskBaseline17.7 breath per minuteStandard Deviation 3.53
Sham CESChange From Baseline in Respiration Rate During Stressful Lethal Force Decision Making TaskFollow-up16.8 breath per minuteStandard Deviation 3.22
p-value: 0.6ANOVA
p-value: 0.9ANOVA
p-value: 0.05ANOVA
Primary

Change From Baseline in Spatial Orientation

Spatial orientation task will involve pointing towards a series of distant (out of visible range) landmarks in the virtual environment and estimating distance to those landmarks. Spatial orientation will be calculated using mean absolute angular error. Larger numbers correlate with higher error.

Time frame: Baseline and follow-up session after 20 CES completed within 4-6weeks

ArmMeasureGroupValue (MEAN)Dispersion
Active CESChange From Baseline in Spatial OrientationBaseline20.7 absolute angle error in degreesStandard Deviation 8.12
Active CESChange From Baseline in Spatial OrientationFollow-up21.2 absolute angle error in degreesStandard Deviation 12.7
Sham CESChange From Baseline in Spatial OrientationBaseline18.8 absolute angle error in degreesStandard Deviation 10.4
Sham CESChange From Baseline in Spatial OrientationFollow-up16.3 absolute angle error in degreesStandard Deviation 10.1
p-value: 0.13ANOVA
p-value: 0.26ANOVA
p-value: 0.44ANOVA
Primary

Change Over Time in Alpha Amylase During Stressful Lethal Force Decision Making Task

Alpha amylase (IU) will be measured through saliva samples. Saliva samples will be taken at five time points, approximately 20 minute increments during the baseline and follow-up sessions.

Time frame: Baseline and follow-up session after 20 CES completed within 4-6weeks

ArmMeasureGroupValue (MEAN)Dispersion
Active CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskBaseline 20min post88.6 IUStandard Deviation 50.6
Active CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskFollow-up Pre68.4 IUStandard Deviation 51
Active CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskBaseline 0min post144 IUStandard Deviation 91.3
Active CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskFollow-up 0min post99.8 IUStandard Deviation 39.3
Active CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskBaseline 40min post110 IUStandard Deviation 87.6
Active CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskBaseline Pre118 IUStandard Deviation 90.6
Active CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskFollow-up 40min post91.2 IUStandard Deviation 49.5
Active CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskBaseline 60min post105 IUStandard Deviation 66.2
Active CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskFollow-up 60min post128 IUStandard Deviation 84.9
Active CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskFollow-up 20min post110 IUStandard Deviation 71.8
Sham CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskFollow-up 60min post97.5 IUStandard Deviation 91.7
Sham CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskBaseline Pre79.1 IUStandard Deviation 69.2
Sham CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskBaseline 0min post131 IUStandard Deviation 121
Sham CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskBaseline 20min post84 IUStandard Deviation 61
Sham CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskBaseline 40min post78.1 IUStandard Deviation 58.2
Sham CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskBaseline 60min post79.8 IUStandard Deviation 61.2
Sham CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskFollow-up Pre61.7 IUStandard Deviation 48.6
Sham CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskFollow-up 0min post129 IUStandard Deviation 101
Sham CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskFollow-up 20min post90.8 IUStandard Deviation 72.6
Sham CESChange Over Time in Alpha Amylase During Stressful Lethal Force Decision Making TaskFollow-up 40min post92.6 IUStandard Deviation 78.6
p-value: 0.1ANOVA
p-value: 0ANOVA
p-value: 0.81ANOVA
p-value: 0.4ANOVA
p-value: 0.35ANOVA
p-value: 0ANOVA
p-value: 0.4ANOVA
Primary

Change Over Time in Cortisol During Stressful Lethal Force Decision Making Task

Cortisol (µg/dL) will be measured through saliva samples. Saliva samples will be taken at five time points, approximately 20 minute increments during the baseline and follow-up sessions.

Time frame: Baseline and follow-up session after 20 CES completed within 4-6weeks

ArmMeasureGroupValue (MEAN)Dispersion
Active CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskBaseline 60min post.29 µg/dLStandard Deviation 0.156
Active CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskBaseline 0min post.54 µg/dLStandard Deviation 0.36
Active CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskFollow-up 0min post.644 µg/dLStandard Deviation 0.433
Active CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskBaseline 40min post.371 µg/dLStandard Deviation 0.194
Active CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskFollow-up 20min post.444 µg/dLStandard Deviation 0.206
Active CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskFollow-up Pre.335 µg/dLStandard Deviation 0.149
Active CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskFollow-up 40min post.407 µg/dLStandard Deviation 0.268
Active CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskBaseline 20min post.57 µg/dLStandard Deviation 0.396
Active CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskFollow-up 60min post.335 µg/dLStandard Deviation 0.198
Active CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskBaseline Pre.293 µg/dLStandard Deviation 0.137
Sham CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskFollow-up 60min post.379 µg/dLStandard Deviation 0.171
Sham CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskBaseline 20min post.655 µg/dLStandard Deviation 0.476
Sham CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskBaseline 40min post.456 µg/dLStandard Deviation 0.252
Sham CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskBaseline 60min post.369 µg/dLStandard Deviation 0.197
Sham CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskFollow-up Pre.345 µg/dLStandard Deviation 0.123
Sham CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskBaseline Pre.415 µg/dLStandard Deviation 0.183
Sham CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskFollow-up 0min post.556 µg/dLStandard Deviation 0.296
Sham CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskFollow-up 20min post.534 µg/dLStandard Deviation 0.292
Sham CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskFollow-up 40min post.417 µg/dLStandard Deviation 0.163
Sham CESChange Over Time in Cortisol During Stressful Lethal Force Decision Making TaskBaseline 0min post.399 µg/dLStandard Deviation 0.105
p-value: 0.18ANOVA
p-value: 0ANOVA
p-value: 0.53ANOVA
p-value: 0.07ANOVA
p-value: 0.46ANOVA
p-value: 0.01ANOVA
p-value: 0.29ANOVA
Primary

Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up

STAI assesses both state and trait anxiety separately with each scale ranging from 20 to 80, with higher scores correlating with greater anxiety. STAI-S is the State Trait Anxiety Inventory - State version, and STAI-T is the State Trait Anxiety Inventory - Trait version.

Time frame: At baseline, at each of the 20 CES sessions completed within 4-6weeks, and at follow-up to be completed within 5 days of last CES

ArmMeasureGroupValue (MEAN)Dispersion
Active CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Baseline Session 60min Post Stress task30.9 score on a scaleStandard Deviation 9.56
Active CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAT-T at follow-up Post CES intervention33.33 score on a scaleStandard Deviation 12.72
Active CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Follow-up Session Pre Stress task33.8 score on a scaleStandard Deviation 15
Active CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Baseline Session 20min Post Stress task35.6 score on a scaleStandard Deviation 11.5
Active CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Follow-up Session 0min Post Stress task34.6 score on a scaleStandard Deviation 12
Active CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Baseline Session Pre-Stress task33.4 score on a scaleStandard Deviation 7.94
Active CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Follow-up Session 20min Post Stress task30.4 score on a scaleStandard Deviation 11.6
Active CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAT-T at baseline Pre CES intervention33.71 score on a scaleStandard Deviation 10.75
Active CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Follow-up Session 60min Post Stress task29.1 score on a scaleStandard Deviation 9.75
Active CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Follow-up Session 40min Post Stress task29.0 score on a scaleStandard Deviation 9.95
Active CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Baseline Session 40min Post Stress task32.4 score on a scaleStandard Deviation 9.79
Active CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Baseline Session 0min Post Stress task39.5 score on a scaleStandard Deviation 10.7
Sham CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Follow-up Session 60min Post Stress task26.1 score on a scaleStandard Deviation 8.13
Sham CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Baseline Session 0min Post Stress task41.6 score on a scaleStandard Deviation 12.2
Sham CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAT-T at baseline Pre CES intervention29.52 score on a scaleStandard Deviation 7.28
Sham CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAT-T at follow-up Post CES intervention32.64 score on a scaleStandard Deviation 7.16
Sham CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Baseline Session 20min Post Stress task34.1 score on a scaleStandard Deviation 9.53
Sham CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Baseline Session 40min Post Stress task30.6 score on a scaleStandard Deviation 8.54
Sham CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Baseline Session 60min Post Stress task29.1 score on a scaleStandard Deviation 6.66
Sham CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Follow-up Session Pre Stress task27.6 score on a scaleStandard Deviation 8.55
Sham CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Follow-up Session 0min Post Stress task33.0 score on a scaleStandard Deviation 10.8
Sham CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Follow-up Session 20min Post Stress task29.3 score on a scaleStandard Deviation 8.55
Sham CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Follow-up Session 40min Post Stress task26.6 score on a scaleStandard Deviation 7.94
Sham CESChange Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-upSTAI-S Baseline Session Pre-Stress task31.0 score on a scaleStandard Deviation 6.62
p-value: 0ANOVA
p-value: 0ANOVA
p-value: 0.2ANOVA
p-value: 0.39ANOVA
p-value: 0.23ANOVA
p-value: 0.45ANOVA
p-value: 0.38ANOVA
p-value: 0.4ANOVA
p-value: 0ANOVA
p-value: 0.38ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026