Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05291533 |
Other study ID # |
19-06020347 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 6, 2022 |
Est. completion date |
August 18, 2023 |
Study information
Verified date |
April 2024 |
Source |
Weill Medical College of Cornell University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
This pilot study proposes to assess acceptability and preliminary efficacy of an intervention
being administered clinically, a virtual reality (VR) mindfulness program. Acceptability and
preliminary efficacy will be determined by 1) patient feedback on their satisfaction with the
intervention evaluated by the Client Satisfaction Questionnaire-8 (CSQ-8); 2) changes in
acute subjective anxiety before and after using the program; 3) changes in subjective
relaxation before and after using the program; 4) changes in global anxiety at referral to
psychology and just prior to discharge; Any patient on units with access to this VR program
who are referred for a psychological evaluation will have the opportunity to engage in the VR
intervention.
Overall Design:
This study is an open trial evaluating the acceptability and efficacy of a VR mindfulness
program being clinically implemented to address acute anxiety in patients admitted to medical
and rehabilitation inpatient units.
VR Mindfulness Program:
Participants referred for a psychological or neuropsychological evaluation will have the
opportunity to complete the study. A study staff member who is not the evaluating clinician
will approach the patient to inquire about their interest in the study and conduct the
informed consent process. Patients are typically referred for a psychological evaluation
based on acute anxiety observed by staff or reported by the patient. The evaluating
psychologist will collaborate with treatment team to make a clinical determination about
whether VR mindfulness is indication (see exclusion criteria below). If it is determined that
the patient could benefit from the VR intervention, a VR team member will facilitate the
administration of a self-report measure on anxiety (GAD-7), obtain subjective ratings of
anxiety and relaxation, and then administer the 5-minute VR mindfulness intervention. After
patient's completion of the intervention, the VR team member will repeat the measures of
subjective anxiety and relaxation. This procedure will be repeated as-needed (determined by
clinical team) or up to three times per week based on patient preference and staff
availability. The CSQ-8 will be administered after the patient's first use of VR mindfulness
and again the day before discharge, if the patient opted to use repeatedly. The study team
will re-administer the GAD-7 on the day prior to the patient's discharge.
Study-specific procedures:
Upon determination by the clinical and study team that a patient is an appropriate candidate
for VR mindfulness, the patient will be informed of the opportunity to participate in the
study. It will be made clear to the patient that participation in the study is voluntary and
will have no impact on their current or future access to care at NYP/WCM. If they agree they
will undergo the informed consent process.
Scientific Rationale for Study Design:
This is an open trial to determine acceptability and efficacy of using VR mindfulness to
address acute anxiety in varied clinical settings. This intervention is already being
implemented clinically, this study seeks to assess acceptability and provide preliminary data
on efficacy of this intervention. No control is being used at this time.
4. Subject Selection
Subjects will be patients admitted to medical and rehabilitation inpatient units at NYP/WCM.
Recruitment:
Patients are identified by their clinical team during their inpatient admission as
appropriate for the VR mindfulness intervention to address acute anxiety.
5. Registration Procedures
Subjects will be registered within the WRG-CT as per the standard operating procedure for
Subject Registration.
6. Study Procedures Upon determination by the treatment team and VR team member that a
patient is an appropriate candidate for VR mindfulness, the patient will be informed of the
opportunity to participate in the study. It will be made clear to the patient that
participation in the study is voluntary and will have no impact on their current or future
access to care at NYP/WCM or their ability to participate in the VR mindfulness intervention.
If they agree they will undergo the informed consent process.
Measures: Listed in the "Outcome Measures" section
Study intervention:
The study is seeking to evaluate the feasibility and preliminary efficacy of a VR mindfulness
intervention. 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.
Study duration, withdrawal and discontinuation:
Subjects will complete study procedures at least one time, with additional uses determined by
need (decided by clinical team) or patient preference (up to three times per week based on
staff availability). They will be followed for the duration of their admission. Study
participation ends when they are discharged or are no longer eligible to use VR. Participants
are free to withdraw from participation in the study at any time upon request.
An investigator may discontinue or withdraw a participant from the study for the following
reasons:
- Significant study intervention non-compliance
- If any clinical adverse event (AE) or other medical condition or situation occurs such
that continued participation in the study would not be in the best interest of the
participant
- If the participant meets an exclusion criterion (either newly developed or not
previously recognized) that precludes further study participation
- Participant unable to participate in VR mindfulness intervention
The reason for participant discontinuation or withdrawal from the study will be recorded on
the Case Report Form (CRF). Subjects who sign the informed consent form and do not receive
the study intervention may be replaced. Subjects who sign the informed consent form and
receive the study intervention, and subsequently withdraw, or are withdrawn or discontinued
from the study will be replaced.