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临床试验/NCT06255119
NCT06255119已完成不适用

The Feasibility of 3D Therapy Thrive for Inpatients With Opioid Use Disorder

3D Therapy, LLC2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Retention in Treatment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Device Feasibility
盲法
Single (Participant)

盲法说明

Subjects were blinded to study condition.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1.18 years or older
  • Current diagnosis of opioid use disorder
  • Current inpatient in detox ATS unit
  • Fluent in English

排除标准

  • Active suicidality
  • History of seizures
  • History of psychosis
  • Severe visual impairment

结局指标

主要结局

Retention in Treatment

时间窗: 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

时间窗: Immediately after each treatment

Feasibility and tolerability of 3DTT was measured by the Side Effects Questionnaire.

次要结局

  • 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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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