Clinical trial NCT03636126: Virtual Reality and tACS for Performance Enhancement
Official title: Virtual Reality and tACS for Performance Enhancement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Law Enforcement Officers
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: Change in score Assessed at Baseline, 2 weeks and 4 weeks.
measure: Insomnia Severity Index (ISI)
timeFrame: Change in score Assessed at Baseline, 2 weeks and 4 weeks.
measure: The Patient Health Questionnaire 8 (PHQ-8)
timeFrame: Change in score Assessed at Baseline, 2 weeks and 4 weeks.
measure: Primary Care Posttraumatic Stress Disorder Screen (PC-PTSD)
timeFrame: Change in score Assessed at Baseline, 2 weeks and 4 weeks.
measure: Generalized Anxiety Disorder (GAD7)
timeFrame: Change in score Assessed at Baseline, 2 weeks and 4 weeks.
Secondary outcomes:
measure: Demographics Questionnaire
timeFrame: Assessed at Baseline
measure: Alcohol Use Disorder Identification Test-Consumption (AUDIT-C)
timeFrame: Assessed at Baseline, 2 weeks and 4 weeks.
measure: Attitudes Toward the Experience Survey
timeFrame: Assessed at 4 weeks
Other outcomes:
Locations:
city: Garland
country: United States
facility: Garland PD
state: Texas
Study officials:
References: