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

Yale University7 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression

Interventions

Virtual realityDEVICE

Virtual reality gear and content will be used to affect and control the audiovisual perception of patients during a single treatment with ketamine/esketamine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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. Data presented here is the number of participants that stated the treatment was Tolerated.

Time frame: 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.

Time frame: baseline up to Immediately post-VR treatment

Change in Overall Treatment Experience Satisfaction

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.

Time frame: Baseline, during and immediately post VR treatment session

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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