Patient Experiences With Virtual Reality Mindfulness Skills Training

NCT05291533 | Completed

• 1 other identifier: 19-06020347
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess acceptability and preliminary efficacy of an intervention being administered clinically, a virtual reality (VR) mindfulness program. It is hypothesized that patients will find VR mindfulness an acceptable intervention and that it will reduce symptoms of anxiety.

Conditions

Anxiety; Distress, Emotional

Outcome Measures

Primary Outcomes (1)

• Change in composite score on Client Satisfaction Questionnaire-8 (CSQ-8; Attkisson & Zwick, 1982)

  An 8-item, empirically validated measure of satisfaction with a clinical program. Scores therefore range from 8 to 32, with lower values indicating lower satisfaction and higher values indicating higher satisfaction.

  Immediately after first intervention (use of VR) and at hospital discharge an average of 10 days later

Secondary Outcomes (3)

• Mean change in Subject Units of Distress (SUDS) from pre- to post-VR

  Immediately before and after each intervention (use of VR), up to two times per week for duration of hospital stay (average 10 days)

• Mean change in Subjective units of relaxation from pre-to post-VR

  Immediately before and after each intervention (use of VR), up to two times per week for duration of hospital stay (average 10 days)

• Mean change in General Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006) from baseline to discharge

  Immediately before first intervention (use of VR) and at hospital discharge an average of 10 days later

Study Arms (1)

Patients using VR Mindfulness Program

OTHER

Participants are inpatients on any NYP/WCM unit that use VR mindfulness programs; any patient referred for a psychological or neuropsychological evaluation by their treatment team will have the opportunity to complete the VR program. The study is seeking to evaluate the feasibility and preliminary efficacy of the VR mindfulness intervention.

Other: Virtual Reality (VR) Mindfulness Program

Interventions

Virtual Reality (VR) Mindfulness Program OTHER

The VR program combines immersive, 3D visuals and audio with mindfulness skills practice. The program is designed to train participants you to calm their bodied and minds and its use is designed to enhance mindfulness practice. VR is a platform that has been used for a variety of applications, including gaming, entertainment, education and training.

Patients using VR Mindfulness Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred to psychology/neuropsychology
• Identified by treatment team for use of VR mindfulness intervention
• Able to provide informed consent or assent
• Patient is over the age of 18

You may not qualify if:

• Has not engaged in VR mindfulness intervention.
• Determination by clinical team that patient cannot or would not benefit from participation in VR.
• Reasons may include history of severe motion sickness or seizures, history of destruction of property, visual disturbance, vertigo, and cognitive impairment, delirium, and current or past diagnosis of a psychotic disorder

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Michelle Pelcovitz

  Weill Cornell Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 22, 2022
• Study Start: May 6, 2022
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)