Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment

Study Overview
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Brief Summary
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Investigators aim to examine the role of audiovisual inputs during treatment with ketamine/esketamine in affecting tolerability and effectiveness of treatment of depressive episodes, by providing patients with a relaxing environment using virtual reality goggles and noise cancelling headphones, and assessing whether these tools can improve the tolerability and effectiveness of treatment with ketamine/esketamine

Official Title
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Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment

Conditions
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Depression

Intervention / Treatment
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* Device: Virtual reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be at least 18 years old Patients must have completed the acute series of treatment and weekly optimization phases of ketamine/esketamine treatment, and currently receiving continuation/maintenance treatment Written consent for the study procedures Ability and willingness, in the investigator's judgement, to comply with the study procedure and study requirements. Exclusion Criteria: Hearing or visual impairment to the degree that would interfere with ability to see or hear VR content. Difficulty in understanding spoken or written English Unable to provide informed consent Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the study procedure (per investigator judgment) Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study. Was previously enrolled/randomized into the study

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>This single arm will include all participants of the study, who will all receive the intervention | Device: Virtual reality<br>* Virtual reality gear and content will be used to affect and control the audiovisual perception of patients during a single treatment with ketamine/esketamine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of VR treatment assessed by qualitative report | Tolerability of VR treatment will be assessed by qualitative report, an open-ended question where the participant is allowed to describe any concerns not covered by SAFTEE assessment. | baseline and Immediately post-VR treatment | 
| Safety of VR treatment assessed by Systematic Assessment of Treatment Emergent Events (SAFTEE) assessment | The SAFTEE assessment will be used to assess adverse events during the trial by the number of participants that had any adverse events while on study. | baseline, during VR treatment and Immediately post-VR treatment | 
| Change in overall treatment experience satisfaction between the pre-VR and VR treatment sessions | Efficacy will be assessed by the difference in overall treatment experience satisfaction (via Likert scale) between the pre-VR and VR treatment sessions. Total scores range from 0 to 10 with higher scores indicating higher satisfaction with the treatment experience. | Baseline and immediately post VR treatment session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) subscale scores | The 5D-ASC measures altered states of consciousness and contains 94 items using visual analogue scales. Score for each will be calculated from 0 to 100 based on measurement of where the participant has drawn the line. Then each subscale is the median score from a pre-defined list of items (eg subscale 2 is median of items 9,81,94). Higher scores means more altered state of consciousness. | baseline, during VR treatment and Immediately post-VR treatment | 
| Change in 5D-ASC total score | The 5D-ASC measures altered states of consciousness and contains 94 items (visual analogue scales. Score for each will be calculated from 0 to 100 based on measurement of where the participant has drawn the line. Total score is the median of all items. Higher scores means more altered state of consciousness. | baseline, during VR treatment and Immediately post-VR treatment | 
| Change in The Clinician-Administered Dissociative States Scale (CADSS) | The CADSS is a 23 item structured clinical interview to assess state dissociation rated by clinicians. Each item is scored from 0 (not at all) to 4 (extreme). Total score range from 0-92 with higher scores indicating greater severity of dissociative experiences. | baseline, 40 minutes and immediately post VR treatment | 
| Change in participant experience | Participant experience will be assessed by self report on whether it was a pleasant vs unpleasant experienceusing a Likert scale. Scores from 0-11 with higher scores indicating a more pleasant experience. | baseline, during VR treatment and Immediately post-VR treatment | 
| Change in level of relaxation | The level of relaxation will be scored using a Likert scale with total score range from 0 to 11. Higher scores indicate a higher level of relaxation. | baseline, during VR treatment and Immediately post-VR treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketamine, esketamine, virtual reality