Law Enforcement OfficersNCT03636126
Virtual Reality and tACS for Performance Enhancement
A study testing VR + TACS in people with Law Enforcement Officers, run by Baylor Research Institute at 1 site in United States.
Trial summary
The chronic stress of police work may reduce human performance through increases in anxiety, depression, pain, and insomnia. Land's End VR may teach mindful meditation that is associated with reduced anxiety, depression, pain, and insomnia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Law Enforcement Officers
- What is being tested?
- VR + TACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2019to 14 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- English-Speaking (The measures have not been validated in other languages).
- Willing and able to provide informed consent and participate in the study visit and study follow-up questionnaires
- Able to position head completely upright (90 degrees from the ground) in order to view the entirety of the Virtual Reality video
Who cannot join
- Hearing or visually impaired where they cannot use the Samsung Gear VR
- History of motion sickness or cyber sickness and unwilling to watch a 10-minute virtual reality video because of it
- Unable to position head completely upright (90 degrees from the ground)
- History of seizures
- Lesions, rashes, or open wounds on face, head, neck, or ears
- Medical device implanted in the head or neck
- Participants with pacemakers
- Participants with known or suspected heart disease
Trial locations and contacts
1 site in 1 country.
About this study
The chronic stress of police work may reduce human performance through increases in anxiety, depression, pain, and insomnia. Land's End VR may teach mindful meditation that is associated with reduced anxiety, depression, pain, and insomnia. tACS may produce similar effects to Selective Serotonin Reuptake Inhibitors (SSRIs) without the side effect risks of SSRIs by stimulating neurotransmitter production and modulating the default mode network, resulting in reduced anxiety, depression, pain, and insomnia. These two technologies have not been investigated as interventions among police officers. Therefore, we propose a pilot randomized waitlist-controlled crossover trial of the feasibility and efficacy of Land's End VR and tACS among police officers.
- Conditions
- Law Enforcement Officers
- Being tested
- VR + TACS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR + TACSDevice
TACS- A regulated class of transcranial alternating current stimulation (tACS), called Cranial Electrotherapy Stimulation (CES) by Fisher Wallace Laboratories (FWL) is FDA-Cleared to treat depression, anxiety, and insomnia (Proof of FDA clearance and 510k provided in the appendix). FWL tACS delivers weak non-invasive electrical stimulation (1-4 milliamps at 15, 500, and 15,000 Hz) to the frontal/temporal brain regions by electrodes placed above the temples. Land's End Virtual Reality Game Meta-analyses show Virtual Reality (VR) is an effective non-pharmacological method that reduces obstacles to human performance such as pain, insomnia, anxiety, sleep deprivation, and a variety of other stress responses.
| Study group | Role | What they receive |
|---|---|---|
| VR + TACS | Experimental | 1. Complete one chapter of the virtual reality game "Land's End" while simultaneously using the tACS system (chapters range in length from approximately 5-20 minutes) after waking up each day (or prior to beginning a work shift).
2. Use the tACS system without the VR for 20 minutes just before sleep (or at the end of a work shift, whichever time point is most convenient). Table 1. Timeline of Study Treatment Receives: Device: VR + TACS |
| No Intervention for 2 Weeks | No intervention | For 2 weeks of the 4 week study, each group (Group A and Group B) will continue work shifts as usual with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS)
The Numerical Rating Scale (NRS) has been validated as a measure of pain intensity and is one of the most commonly used measures in assessing pain. The NRS asks patients to rate their pain severity on a 0 to 10 scale, with 0 being "no pain" to 10 being "so severe that you can't stand it."
Measured: Change in score Assessed at Baseline, 2 weeks and 4 weeks.
Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a 7-item, self-report instrument that assesses the severity of insomnia. The ISI has adequate reliability and validity and is frequently used in randomized controlled trials of sleep interventions. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Measured: Change in score Assessed at Baseline, 2 weeks and 4 weeks.
The Patient Health Questionnaire 8 (PHQ-8)
The PHQ-8 is a brief self-report measure of major depressive disorder. The PHQ-8 is considered to be valid measure of depression for population-based studies and clinical populations with a cut off score of equal or greater than 10 as the diagnostic for current depression. The PHQ-8 is derived from the PHQ-9 by removing the last question regarding suicide assessment.
Measured: Change in score Assessed at Baseline, 2 weeks and 4 weeks.
Primary Care Posttraumatic Stress Disorder Screen (PC-PTSD)
The PC-PTSD is a 4-item"yes" or "no" screen designed for use in medical settings and is the current screening instrument used in the VA system to screen for PTSD. This is considered a psychometrically sound screen for determining the presence and absence of PTSD in the VA setting and has also been used in the civilian primary care population. With a cut-off score of 3, the PC-PTSD has shown 85% diagnostic efficiency, 78% sensitivity, and 87% specificity.
Measured: Change in score Assessed at Baseline, 2 weeks and 4 weeks.
Generalized Anxiety Disorder (GAD7)
The GAD7 is a 7-item questionnaire that measures severity of anxiety. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Therefore, GAD-7 scores range from 0 to 21, with scores of 5, 10, and 15 representing mild, moderate, and severe anxiety symptom levels, respectively
Measured: Change in score Assessed at Baseline, 2 weeks and 4 weeks.
Secondary outcomes (3)
Demographics Questionnaire
Participants will be asked to provide standard demographic information (i.e., age, gender, race/ethnicity, level of education, etc.). Participants will also be asked about hearing and visual impairment as well as any history of motion sickness.
Measured: Assessed at Baseline
Alcohol Use Disorder Identification Test-Consumption (AUDIT-C)
Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) is a 3-item alcohol screen that can identify problem alcohol use. The AUDIT-C is scored o a scale of 0-12, each question has 5 answer choices with "a" being 0 points and "e" being 4 points.
Measured: Assessed at Baseline, 2 weeks and 4 weeks.
Attitudes Toward the Experience Survey
The Attitudes Toward the Experience Survey is an 8-item NRS that will be used to measure the participant's attitude toward the VR experience. Participants rate the degree to which they agree with the statements on a 1-10 scale, with 0 being "strongly disagree" and 10 being "strongly agree."
Measured: Assessed at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start3 Jan 2019
- Primary completion14 Oct 2020
- Study completion14 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Law Enforcement OfficersStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The total study time will be 4 weeks. Participants will be asked to use the VR and tACS for two of these four weeks. Participants will be randomly assigned to one of two groups: A) a group that uses the tACS+VR for weeks 1 \& 2 or B) a group that uses the tACS+VR for weeks 3 \& 4.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636126
- Sponsor's protocol ID
- 018-181
- Status last verified
- Jul 2021
- First submitted
- 13 Aug 2018
- Last updated
- 26 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality and tACS for Performance Enhancement
- ClinicalTrials.gov ID
- NCT03636126
- Acronym / sponsor ID
- 018-181
- Conditions
- Law Enforcement Officers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 17 Aug 2018 (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.
The chronic stress of police work may reduce human performance through increases in anxiety, depression, pain, and insomnia. Land's End VR may teach mindful meditation that is associated with reduced anxiety, depression, pain, and insomnia. tACS may produce similar effects to Selective Serotonin Reuptake Inhibitors (SSRIs) without the side effect risks of SSRIs by stimulating neurotransmitter production and modulating the default mode network, resulting in reduced anxiety, depression, pain, and insomnia. These two technologies have not been investigated as interventions among police officers. Therefore, we propose a pilot randomized waitlist-controlled crossover trial of the feasibility and efficacy of Land's End VR and tACS among police officers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The total study time will be 4 weeks. Participants will be asked to use the VR and tACS for two of these four weeks. Participants will be randomly assigned to one of two groups: A) a group that uses the tACS+VR for weeks 1 \& 2 or B) a group that uses the tACS+VR for weeks 3 \& 4.
| Arm | Type | Receives |
|---|---|---|
| VR + TACS | Experimental | Device: VR + TACS1. Complete one chapter of the virtual reality game "Land's End" while simultaneously using the tACS system (chapters range in length from approximately 5-20 minutes) after waking up each day (or prior to beginning a work shift). 2. Use the tACS system without the VR for 20 minutes just before sleep (or at the end of a work shift, whichever time point is most convenient). Table 1. Timeline of Study Treatment |
| No Intervention for 2 Weeks | No intervention | –For 2 weeks of the 4 week study, each group (Group A and Group B) will continue work shifts as usual with no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age and older
- English-Speaking (The measures have not been validated in other languages).
- Willing and able to provide informed consent and participate in the study visit and study follow-up questionnaires
- Able to position head completely upright (90 degrees from the ground) in order to view the entirety of the Virtual Reality video
Key exclusion criteria (8 listed)
- Hearing or visually impaired where they cannot use the Samsung Gear VR
- History of motion sickness or cyber sickness and unwilling to watch a 10-minute virtual reality video because of it
- Unable to position head completely upright (90 degrees from the ground)
- History of seizures
- Lesions, rashes, or open wounds on face, head, neck, or ears
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 |
|---|---|---|
| VR + TACSTACS- A regulated class of transcranial alternating current stimulation (tACS), called Cranial Electrotherapy Stimulation (CES) by Fisher Wallace Laboratories (FWL) is FDA-Cleared to treat depression, anxiety, and insomnia (Proof of FDA clearance and 510k provided in the appendix). FWL tACS delivers weak non-invasive electrical stimulation (1-4 milliamps at 15, 500, and 15,000 Hz) to the frontal/temporal brain regions by electrodes placed above the temples. Land's End Virtual Reality Game Meta-analyses show Virtual Reality (VR) is an effective non-pharmacological method that reduces obstacles to human performance such as pain, insomnia, anxiety, sleep deprivation, and a variety of other stress responses. | Device | VR + TACS |
Primary outcome
Numeric Rating Scale (NRS)
Time frame: Change in score Assessed at Baseline, 2 weeks and 4 weeks.
The Numerical Rating Scale (NRS) has been validated as a measure of pain intensity and is one of the most commonly used measures in assessing pain. The NRS asks patients to rate their pain severity on a 0 to 10 scale, with 0 being "no pain" to 10 being "so severe that you can't stand it."
Insomnia Severity Index (ISI)
Time frame: Change in score Assessed at Baseline, 2 weeks and 4 weeks.
The Insomnia Severity Index (ISI) is a 7-item, self-report instrument that assesses the severity of insomnia. The ISI has adequate reliability and validity and is frequently used in randomized controlled trials of sleep interventions. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
The Patient Health Questionnaire 8 (PHQ-8)
Time frame: Change in score Assessed at Baseline, 2 weeks and 4 weeks.
The PHQ-8 is a brief self-report measure of major depressive disorder. The PHQ-8 is considered to be valid measure of depression for population-based studies and clinical populations with a cut off score of equal or greater than 10 as the diagnostic for current depression. The PHQ-8 is derived from the PHQ-9 by removing the last question regarding suicide assessment.
Primary Care Posttraumatic Stress Disorder Screen (PC-PTSD)
Time frame: Change in score Assessed at Baseline, 2 weeks and 4 weeks.
The PC-PTSD is a 4-item"yes" or "no" screen designed for use in medical settings and is the current screening instrument used in the VA system to screen for PTSD. This is considered a psychometrically sound screen for determining the presence and absence of PTSD in the VA setting and has also been used in the civilian primary care population. With a cut-off score of 3, the PC-PTSD has shown 85% diagnostic efficiency, 78% sensitivity, and 87% specificity.
Generalized Anxiety Disorder (GAD7)
Time frame: Change in score Assessed at Baseline, 2 weeks and 4 weeks.
The GAD7 is a 7-item questionnaire that measures severity of anxiety. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Therefore, GAD-7 scores range from 0 to 21, with scores of 5, 10, and 15 representing mild, moderate, and severe anxiety symptom levels, respectively
3 secondary outcomes
Demographics Questionnaire
Time frame: Assessed at Baseline
Alcohol Use Disorder Identification Test-Consumption (AUDIT-C)
Time frame: Assessed at Baseline, 2 weeks and 4 weeks.
Attitudes Toward the Experience Survey
Time frame: Assessed at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Individual participant dataSharing planned: Undecided
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 VR + TACS in people with Law Enforcement Officers, run by Baylor Research Institute 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 26 Jul 2021. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numeric Rating Scale (NRS) (time frame: Change in score Assessed at Baseline, 2 weeks and 4 weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2021; AzTrials last refreshed its copy on 30 Oct 2026.