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临床试验/NCT05835921
NCT05835921进行中(未招募)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 200 人开始时间: 2023年3月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
2
主要终点
Reduced Use of Drug Using Days

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 stimulant use disorder (SUD) 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.

详细描述

We propose testing a novel VR paradigm for efficacy for increasing future self-identification, future time perspective, delayed reward preference, and recovery/abstinence outcomes. All participants will undergo VR, behavioral testing, longitudinal follow-up, and repeated drug testing. Both groups will receive the 5-min Park VR habituation (no avatar). The VR group will receive the Future Reality Portal VR experience plus mRecovery daily reminders for 30 days. TAU participants will experience the Park VR habituation and a matched-duration Park VR experience without an avatar and a non-personalized mRecovery ("Generic") daily reminder. All personality and behavioral assessments, and follow-up procedures will be mirrored between groups, with identical participant burden.

All participants will be phone screened and interviewed in-person to determine eligibility (see Human Subjects). We target a total of N=88 participants in StUD recovery (ns=44 for each of the 2 groups). These numbers include additional participants budgeted for attrition and unforeseen problems (7% over target sample) to obtain usable data for N=82, ns=41 per group. Outpatient participants (≥14 days and <6 months abstinent) performing recovery activities will be recruited in-person and through flyers placed at recovery-oriented facilities, e.g., local treatment/detox centers and recovery houses. Our pilot study currently recruits from 5 local addiction treatment providers. TAU comprises the recovery programming a participant would otherwise engage (intensive outpatient, mutual-help groups, individual counseling), but varies according to individualized treatment plans and participant-motivated activities. Randomization will largely address heterogeneity, with stratification by recruitment site to equally distribute site-specific variability across groups. During the interview, participants will provide informed consent, demographic data, drug/alcohol history with the Structured Clinical Interview for DSM-5 [SCID] to determine type and severity of use disorders (elaborated by the Timeline Followback [TLFB] for the 35 days prior to treatment to quantify use patterns in the three most-abused substances-acknowledging common polysubstance use), mental health assessments using CAT-MH™ (validated adaptive assessment for depression, anxiety, PTSD, severe mental illness, risky sexual behavior, and social support [121]), a quality-of-life scale, currently-used psychotropic medications, current/previous treatment history, and personal information. Participants will also perform a brief 1-minute behavioral delay discounting task. We will collect voice samples and studio-lit, high-resolution, multi-angle photos for creating avatars. Importantly, participants will name chief motivations for recovery and/or abstinence (from rank-ordered quality of life items), costs of prior StUD behavior (from items 5-9 in SCID detailing social, physical, and psychological problems), and hopes for their future. Urine and breath will be screened for illicit drugs and alcohol (ethyl glucuronide). A single lapse to drug/alcohol use will not necessarily be exclusionary if subjects remain committed to recovery (potentially allowing a positive screen to permit inclusion in the study). Relapse, i.e., return to undesired drug use (analogous to NIAAA's recent definition of AUD recovery) or disinterest in long-term abstinence (recovery) before study day will be exclusionary.

Drug and Alcohol Use. We will quantify StUD severity, use pattern, and drug types with the Structured Clinical Interview for DSM-5 [SCID-RV]. The Timeline Followback [TLFB] will provide daily use pattern and amount within the previous 35 days for the three most-used drugs, preceding treatment, and also to quantify post-study use, as required.

Recovery Activities. We will characterize recovery-related activities in all participants, such as intensive outpatient, mutual-help (e.g., 12-Step, SMART), or individual (counselor, psychiatrist) at interview, study day, and follow-ups to quantify type, frequency, and philosophical orientation of activities engaged.

Personality, Traits, and Mood States. We will assess mental health traits (CAT-MH™ validated adaptive assessment for depression, anxiety, PTSD, severe mental illness, risky sexual behavior, and social support), childhood trauma (ACE-Q), self-efficacy ('confidence in maintaining recovery'; 0-100 scale anchored by "not confident at all" to "very confident"), a single-item craving assessment ("How much do I crave drugs and/or alcohol right now?"), quality of life (QoL), Mood States (modified from), state anxiety (STAI short form), time perspective (ZTPI), reward and punishment sensitivity (SRSPQ), impulsivity and SS (UPPS-P), and IQ (WTAR). Some of these will be administered repeatedly, to assess state changes associated with the VR experience. A brief suicide screen (ASR) performed at the interview, and before and after the intervention on the study day will monitor participants' safety. STAI performed before the Future Reality Portal will ensure low state anxiety for participant safety.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Abstinence between ≥14 days and ≤1 year
  • At least 18 years old
  • 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
  • Less than 18 years old
  • 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

Reduced Use of Drug Using Days

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

The Virtual Reality Avatar experience will reduce drug using days.

Increased Length of Abstinence

时间窗: 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.

Increased (overall) Abstinence

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

The Virtual Reality Avatar experience will increase abstinence.

Future Self-identification

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

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

Delayed Reward Preference

时间窗: 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 Time Perspective

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

The Virtual Reality Avatar experience will increase future time perspective.

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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