Skip to main content
OpenTrials
Completed

NCT Number: NCT06139016

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit

New Haven, Connecticut, 06520, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality

Device

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

Primary outcomes

  1. Tolerability of VR Treatment Assessed by Qualitative Report

    Time frame: Immediately post-VR treatment

    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.

  2. Safety of VR Treatment Assessed by Systematic Assessment of Treatment Emergent Events (SAFTEE) Assessment

    Time frame: baseline up to Immediately post-VR treatment

    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.

  3. Change in Overall Treatment Experience Satisfaction

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

    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.

Secondary outcomes

  1. Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) Subscale Scores

    Time frame: baseline, during VR treatment and Immediately post-VR treatment

    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.

  2. Change in 5D-ASC Total Score

    Time frame: baseline, during VR treatment and Immediately post-VR treatment

    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.

  3. Change in The Clinician-Administered Dissociative States Scale (CADSS)

    Time frame: baseline, during VR and immediately post VR treatment

    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.

  4. Change in Participant Experience

    Time frame: baseline, during VR treatment and Immediately post-VR treatment

    Participant experience will be assessed by self report on whether it was a "pleasant vs unpleasant experience"using a Likert scale. Scores from 0-10 with higher scores indicating a more pleasant experience.

  5. Change in Level of Relaxation

    Time frame: baseline, during VR treatment and Immediately post-VR treatment

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Acronym: VR-KET

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.