Smartphone-based Virtual Reality Exposure and Standard Relaxation Training for Anxiety on an Inpatient Psychiatric Unit

Study Overview
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Brief Summary
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The purpose of this study is to compare a smartphone-based virtual reality exposure with standard relaxation training for anxiety and associated symptoms (including pain) on an inpatient psychiatric unit, and whether patients find it usable and beneficial.

Detailed Description
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The study is open only to inpatients on a specific Mayo Clinic Rochester psychiatric hospital unit, the Mood Disorders Unit. Two different techniques for reducing anxiety will be tried. The first time patients report anxiety, they will be asked to listen to a 15 minute audio CD guiding them through relaxation strategies. The second time patients are anxious, they will be given a cardboard VR goggle set and will view 15 minutes of unguided VR. Before and after each session, they will fill out a short survey of anxiety and related symptoms (including pain ratings) and their reaction to each technique. They will be asked to try each technique at least once during your hospital stay.

Official Title
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Comparing a Smartphone-based Virtual Reality Exposure With Standard Relaxation Training for Anxiety on an Inpatient Psychiatric Unit

Conditions
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Anxiety, Pain

Intervention / Treatment
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* Behavioral: iPhone Google Cardboard virtual reality meditation/relaxation app
* Behavioral: Standard relaxation training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Hospitalized on inpatient Mayo Clinic Mood Disorders psychiatric unit (Generose 3W). Exclusion Criteria: Inability to understand English. Patients with primary substance use disorders, primary psychotic disorders, major neurocognitive disorders and active self-harm behaviors and seizure disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: First episode of anxiety: standard relaxation training<br>During a subject's first episode of anxiety the subject will be offered a session of standard relaxation training. | Behavioral: Standard relaxation training<br>* 15 minute sessions of guided imagery using Mayo Clinic Patient Education CD-ROM Relaxation for Your Mind and Body<br>|
| Experimental: Second episode of anxiety: virtual reality relaxation<br>During a subject's second episode of anxiety the subject will be offered a session of virtual reality exposure available through the iPhone Google Cardboard virtual reality meditation/relaxation app. | Behavioral: iPhone Google Cardboard virtual reality meditation/relaxation app<br>* Virtual reality meditation/relaxation app that has 6 scenes of 360° visual imagery with soothing music. The patient can spend about 15 minutes exploring the app.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety | Assessment of anxiety with Subjective Units of Distress Scale (SUDS); this 0-100 scale has anchors and guidance for patients to rate their anxiety, 100 is highest anxiety/distress you have ever felt, 50 is moderate anxiety/distress; uncomfortable, but can continue to function, and 0 is no stress; totally relaxed. | Baseline, approximately 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in associated emotions rating | The patient will be asked to write up to 3 more associated emotions and rate them 0-10, 10=strongest intensity | Baseline, approximately 90 minutes | 
| Change in pain | Assessment of pain with Numeric Pain Intensity Scale (NPIS); the scale is measured on a 0-10 scale with 0 equating to no pain and 10 being the most excruciating pain patient has ever felt. | Baseline, approximately 90 minutes | 
| Change in blood pressure | Measured in mmHg | Baseline, approximately 90 minutes | 
| Change in heart rate | Measured in beats per minute | Baseline, approximately 90 minutes | 
| Change in respiratory rate | Measured in breaths per minute | Baseline, approximately 90 minutes |