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OpenTrials
Completed

NCT Number: NCT03636126

Virtual Reality and tACS for Performance Enhancement

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.

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Key information

Conditions

Law Enforcement Officers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Garland PD

Garland, Texas, 75042, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

VR + TACS

Device

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.

Primary outcomes

  1. 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."

  2. 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).

  3. 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.

  4. 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.

  5. 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

Secondary outcomes

  1. Demographics Questionnaire

    Time frame: Assessed at Baseline

    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.

  2. Alcohol Use Disorder Identification Test-Consumption (AUDIT-C)

    Time frame: Assessed at Baseline, 2 weeks and 4 weeks.

    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.

  3. Attitudes Toward the Experience Survey

    Time frame: Assessed at 4 weeks

    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."

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 17, 2018
Registry last updated
Jul 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.