The Feasibility of VR for OUD
The Feasibility of 3D Therapy Thrive for Inpatients With Opioid Use Disorder
1 other identifier
interventional
40
1 country
1
Brief Summary
This study aims to evaluate feasibility of a virtual reality software device and measure the effects of the intervention on OUD patient mood, tension and cravings, as well as the effect of treatment on patient retention to their inpatient detox protocol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 18, 2022
CompletedFirst Submitted
Initial submission to the registry
June 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedFirst Posted
Study publicly available on registry
February 13, 2024
CompletedFebruary 13, 2024
October 1, 2023
1.2 years
June 20, 2023
February 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Retention in Treatment
Medical record indicating whether patient completed detox protocol (i.e., completed, left against medical advice, administratively discharged, or moved to higher level of care)
At departure from facility, through study completion, an average of 10 days
Feasibility and Tolerability of 3DTT
Feasibility and tolerability of 3DTT was measured by the Side Effects Questionnaire.
Immediately after each treatment
Secondary Outcomes (3)
Mood
Before and after each treatment, approximately every other day for up to 5 days
Anxiety
Before and after each treatment, approximately every other day for up to 5 days
Cravings
Before and after each treatment, approximately every other day for up to 5 days
Study Arms (2)
Active VR Group
ACTIVE COMPARATORParticipants received the active virtual therapy intervention.
Control Group
NO INTERVENTIONA group of patients concurrently on the ATS unit, otherwise eligible to participate in the study who did not enroll, and did not receive an intervention.
Interventions
A novel virtual reality software intervention that utilizes elements of Cognitive Behavioral Therapy to improve outcomes for inpatients with OUD.
Eligibility Criteria
You may qualify if:
- years or older
- \. Current diagnosis of opioid use disorder
- \. Current inpatient in detox ATS unit
- \. Fluent in English
You may not qualify if:
- Active suicidality
- History of seizures
- History of psychosis
- Severe visual impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- 3D Therapy, LLClead
Study Sites (1)
The Gavin Foundation
Quincy, Massachusetts, 02170, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Subjects were blinded to study condition.
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2023
First Posted
February 13, 2024
Study Start
October 18, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
February 13, 2024
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share