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

Not Applicable

• Conditions: Depression
• Interventions: Device: Virtual reality

• Registration Number: NCT06139016
• Lead Sponsor: Yale University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-18
• Study Start: 2024-07-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Virtual reality	This single arm will include all participants of the study, who will all receive the intervention

Primary Outcome Measures

Name	Time	Method
Tolerability of VR treatment assessed by qualitative report	baseline and 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.
Safety of VR treatment assessed by Systematic Assessment of Treatment Emergent Events (SAFTEE) assessment	baseline, during VR treatment and 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.
Change in overall treatment experience satisfaction between the pre-VR and VR treatment sessions	Baseline 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 Outcome Measures

Name	Time	Method
Change in participant experience	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 0-11 with higher scores indicating a more pleasant experience.
Change in level of relaxation	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.
Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) subscale scores	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.
Change in 5D-ASC total score	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.
Change in The Clinician-Administered Dissociative States Scale (CADSS)	baseline, 40 minutes 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.

Trial Locations

Locations (1)

Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit; 🇺🇸 New Haven, Connecticut, United States