The Feasibility of VR for OUD

Not Applicable

Completed

• Conditions: Opioid Use Disorder
• Interventions: Device: 3D Therapy Thrive

• Registration Number: NCT06255119
• Lead Sponsor: 3D Therapy, LLC

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.

Detailed Description

The primary objective of this study is to evaluate the feasibility and preliminary effectiveness of a novel virtual reality (VR) based intervention; 3D Therapy Thrive (3DTT). Inpatient detoxification can improve outcomes for individuals with opioid use disorder (OUD), however patients often leave treatment early due to mood, tension, and cravings associated with opioid withdrawal. Subjects were recruited from a community inpatient detoxification program and received up to two sessions of 3DTT. The patients completed surveys to assess their mood, distress, cravings, and overall satisfaction with the experience. Retention was measured by protocol completion as reported by clinic staff, independent of the study. A group of patients with OUD consecutively admitted to the program comprised a comparison treatment-as-usual (TAU) group.

Study Timeline

• Study Start: 2022-10-18
• Study First Submitted: 2023-06-20
• Status Verified: 2023-10
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Study First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Study First Posted: 2024-02-13
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active VR Group	3D Therapy Thrive	Participants received the active virtual therapy intervention.

Primary Outcome Measures

Name	Time	Method
Retention in Treatment	At departure from facility, through study completion, an average of 10 days	Medical record indicating whether patient completed detox protocol (i.e., completed, left against medical advice, administratively discharged, or moved to higher level of care)
Feasibility and Tolerability of 3DTT	Immediately after each treatment	Feasibility and tolerability of 3DTT was measured by the Side Effects Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Mood	Before and after each treatment, approximately every other day for up to 5 days	Depressive symptoms as measured by the AB-POMS depression scale (0-4, not at all to extremely)
Anxiety	Before and after each treatment, approximately every other day for up to 5 days	Anxiety symptoms as measured by the AB-POMS scale (0-4, not at all to extremely)
Cravings	Before and after each treatment, approximately every other day for up to 5 days	Opioid cravings as measured by the Visual Analog Scale (1-10, with higher scores indicating greater cravings.)

Trial Locations

Locations (1)

The Gavin Foundation; 🇺🇸 Quincy, Massachusetts, United States