NCT05835921

Enhancing Prospective Thinking in Early Recovery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Future Self-Identification. Participants will report how similar and connected they feel to their Future Self with visual representations (i.e., Venn-style circle pairs, labeled with the text 'Current Self' and 'Future Self', varying in the degree of overlap). These valid and reliable indices of future self-identification predict future-oriented behavior (financial savings) and delay discounting. We will measure future self-identification before and after the intervention to assess VR-induced shifts. While future self-identification and delay discounting both quantify aspects of future orientation, our pilot suggests that these constructs are partially independent (pre- versus post-VR change in future self-similarity and delay discounting were only weakly associated \[r=.10\]), highlighting the importance of capturing non-overlapping variance. VR Questionnaire. As in the pilot study, participants will indicate presence (the subjective experience of actually 'being there' in the virtual environment) in addition to equipment usability and VR comfort-such as eyestrain, headache, or motion sickness-on a visual analog scale. VR Questionnaire. As in the pilot study, participants will indicate presence (the subjective experience of actually 'being there' in the virtual environment \[135\]) in addition to equipment usability and VR comfort-such as eyestrain, headache, or motion sickness-on a visual analog scale (modified from \[104\]). Behavioral tasks. Delay Discounting. Participants will perform an adjusting-amount delay discounting task before and after VR to quantify relative preference for immediate versus delayed rewards. The 1-min DD task performed at the interview will obviate concerns of nonsystematic behavior in the forms of total or zero discounting (rendering the task's data uninterpretable). Choices between smaller immediate versus larger delayed monetary rewards adjust the next trial's immediate amount down for immediate choices and up for delayed choices, allowing the procedure to converge on indifference points at various delays. Choices are presented as e.g., "Which would you prefer? $50 today OR $100 after 1 week" using E-Prime® presentation software on a laptop. The delayed amount of $100 is delayed by 2 days, 1 week, 1 month, 6 months, 1 year, and 5 years, with titrating immediate amounts that converge on a point of indifference. For each delay, the immediate amounts are initially half the delayed amount, and adjusted up or down on subsequent trials. Thirty choice trials are presented; 5 trials for each of the 6 delays, with 4 additional control trials to assess attentive responding. Amount/delay combinations and the presentation side for each trial are pseudorandomized. The degree of discounting as a function of delay can be readily quantified as k, the fitted parameter derived from nonlinear regression on indifference points, i.e., (y=A/(1+kD) where y=indifference points, A=delayed amount, and D=delay). Curve-fitting assumes a particular discounting function, however, which may not describe all decision-makers. We will use the model-free area under the curve approach, which yields more normally distributed data . The DD task is an objective measurement of intertemporal decision-making and is sensitive to manipulations affecting delayed reward preference, thus permitting us to quantify the effect of VR on delay-of-reward behavior, acutely and longitudinally. This task version is the same as used in the pilot study, except that in the pilot study an additional fMRI version was used that presented avatar images. In the current proposal, the VR effects on discounting are directly quantified (pre-VR vs. post-VR comparison), with no avatars shown during either discounting task. Thus, shifts in discounting are attributed to prospective induction from the Future Reality Portal experience. Executive Tasks. Stroop: The 144-trial color/word mismatch test of executive attention will provide a baseline of cognitive inhibition and flexibility, predicted to correlate with better recovery outcomes. Operation Span: Participants will perform 172 trials requiring holding letters in memory while solving simple math problems, predicted to correlate with greater baseline delay-of-reward. mRecovery. Using the method described in Preliminary data, we will reinvigorate the VR experience for 30 days by sending daily images of a person on the park bench (the Recovery Future Self for the VR group, or a Generic Person for TAU) to participants' smartphones at randomized evening times (5PM-10PM). Low-cost devices will be provided to any participant without a smartphone. Image viewing is ensured with logged daily responses to the recovery confidence question, as explained to participants on the study day (with a payment contingency). The Generic Person is age/sex/race-matched to the participant from an authorized-use researcher face photo library we currently employ in another ongoing study. Longitudinal follow-up. Participants will return after 30 days and 6 months for follow-up assessments, including a breathalyzer, a 6-month detection-window drug/alcohol screen (urine screen and fingernail test with EtG), SCID interview (and TLFB to characterize any detected or reported substance use), delay discounting, and quality of life inventory. High retention will be ensured with multiple reminder emails and phone calls, and importantly, the "helper" contacts provided at the interview, in addition to social media contact information obtained. Our preliminary data suggest that retention will easily exceed 90% using our current methods.

Conditions

• Stimulant Use
• Substance Use Disorders

Interventions

Type	Name	Description
DEVICE	Virtual Reality	They will receive a Virtual Reality Park experience, which is an empty park with no avatars. They will then have a Virtual Reality Avatar experience, where they will see an avatar resembling themselves in a park setting.
DEVICE	Virtual Reality	They will receive a Virtual Reality Park experience, which is an empty park with no avatars.

Timeline

• Start date: 2023-03-28
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2023-04-28
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study