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临床试验/NCT06302413
NCT06302413招募中不适用

Enhancing Prospective Thinking in Early Recovery

Indiana University2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
2
主要终点
Increased Length of Abstinence

研究概览

简要总结

The goal of this clinical trial is to use a novel virtual reality intervention to test for efficacy in reducing alcohol use and increasing abstinence, with concomitant increases in future self-identification, future time perspective, and delay-of-reward, in early recovering alcohol use disorder (AUD) persons. The main question[s] this trial aims to answer are:

Will the Virtual Reality (VR) intervention decrease the number of stimulant use days? Will the VR intervention produce longer abstinence periods during follow-up visits? Will the VR intervention increase alcohol abstinence rates? Will the VR intervention increase future self-identification? Will the VR intervention increase self-reported future time perspective? Will the VR intervention increase preference for delayed rewards in a laboratory delay discounting task on the study day? Will the VR intervention produce gains in the behavioral effects of future self-identification, future time perspective, and delayed rewards at the 30-day and 6-month follow-ups? Researchers will compare the experimental and control groups to see if there are differences in the results for the questions outlined above.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

All study participants are randomly assigned to a group prior to study enrollment. Participants will not be made aware of their group assignment.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Abstinence between ≥14 days and ≤1 year
  • Verbal endorsement of commitment to recovery
  • Outpatient
  • Psychotropic drugs for SUD-comorbidity
  • Drug/alcohol abstinence ≥ 24 hours at the time of the study day visit
  • English comprehension

排除标准

  • Unstable medical disorders
  • Habitual drug use
  • Mu-opioid drugs
  • Smell/taste disorders
  • Unstable psychiatric conditions
  • Extravagant/elaborate face tattoos

研究组 & 干预措施

Virtual Reality

Experimental

Participants in this arm will receive the following interventions:

Virtual Reality Park Virtual Reality Avatar

干预措施: Virtual Reality (Device)

Treatment As Usual

Placebo Comparator

Participants in this arm will receive the following interventions:

Virtual Reality Park

干预措施: Virtual Reality (Device)

结局指标

主要结局

Increased Length of Abstinence

时间窗: Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.

The Virtual Reality Avatar experience will increase the length of abstinence periods.

Future Time Perspective with the Delayed Discounting Behavioral Task and Future Self Continuity Questionnaire

时间窗: Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.

The Virtual Reality Avatar experience will increase future time perspective.

Reduced Use of Drug Using Days

时间窗: Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit

The Virtual Reality Avatar experience will reduce drug using days.

Increased (overall) Abstinence

时间窗: Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.

The Virtual Reality Avatar experience will increase abstinence.

Delayed Reward Preference with the Delayed Discounting Behavioral Task

时间窗: Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.

The Virtual Reality Avatar experience will increase preference for delayed rewards.

Future Self-identification with Future Self Continuity Questionnaire

时间窗: Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit

The Virtual Reality Avatar experience will increase future self-identification.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brandon G. Oberlin, PhD

Assistant Professor

Indiana University

研究点 (2)

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