An interventional study of Virtual Reality and Treatment as Usual (TAU) in Dual Diagnosis, Risk Youth and Antisocial Behavior, sponsored by Universidad Francisco de Vitoria. Recruiting at 1 site in Spain. Open to participants aged 13 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Universidad Francisco de Vitoria · Not applicable, Interventional, and Treatment
The goal of this RCT is to evaluate the effects of a virtual reality intervention on self-efficacy regarding alcohol and cannabis use among at-risk youth in various residential mental health treatment centers who have co-occurring disorders and are under the care of the association where they receive treatment. The main question it aims to answer is:
Participants will be randomly assigned to each condition and will be evaluated before and after one month. In the experimental group, participants will receive a treatment session using VR software, during which they will undergo training in the following modules: The first phase is an assessment phase, during which objective measures are determined for 1) emotional recognition, 2) avoidance/approach toward related stimuli, 3) degree of compliance with social pressure, and 4) craving in the presence of the drug, exposure to cues, and/or conditioned contexts.
Adolescence constitutes a developmental stage characterized by heightened neurobiological and psychosocial vulnerability. During this period, significant maturational changes occur at the cerebral, emotional, and social levels, increasing susceptibility to the development of risk behaviors and mental health problems. Among these behaviors, antisocial conduct and substance use are particularly prominent, frequently emerging in an interconnected manner.
Adolescents and young people are at high risk of engaging in health-damaging behaviors, especially antisocial behavior and drug use. In this regard, juvenile offenders and youths involved in the juvenile justice system display significantly higher rates of substance use than the general population, particularly alcohol and cannabis consumption. Previous research has consistently shown that early substance use not only results from pre-existing psychosocial vulnerabilities, but also contributes to the perpetuation and aggravation of social exclusion, school dropout, violence, and criminal recidivism trajectories.
Scientific literature has demonstrated a strong association between mental disorders and substance use in adolescent populations. In particular, externalizing disorders such as Attention-Deficit/Hyperactivity Disorder (ADHD) and conduct disorder exhibit the strongest association with substance abuse. These disorders are characterized by impaired inhibitory control, impulsivity, sensation seeking, and emotional dysregulation, all of which increase vulnerability to early initiation of substance use and the subsequent development of addictive behaviors.
Moreover, there is a significant relationship between substance use and other psychopathological conditions, including depression, anxiety, and trauma-related symptoms. Many adolescents engage in substance use as a maladaptive emotional coping strategy, especially in contexts characterized by psychosocial adversity, family neglect, victimization, or early traumatic experiences. This bidirectional interaction between psychopathology and substance use contributes to the emergence of dual pathology, thereby complicating both clinical progression and therapeutic intervention.
When substance use emerges during adolescence in association with socially disadvantaged environments and antisocial behavior, treatment becomes particularly challenging due to its multifactorial nature. Individual, familial, social, and neurobiological factors interact dynamically, facilitating the chronicity of the problem. Furthermore, early substance use has been identified as a relevant factor in the persistence of antisocial behavior into adulthood, increasing the risk of social exclusion, unemployment, interpersonal conflict, and psychiatric disorders later in life.
Understanding the predictive factors associated with substance use and relapse in this population is essential for improving treatment effectiveness. Recent research has highlighted several psychological variables associated with addiction risk, including impulsivity, callous-unemotional traits, reduced empathy, deficits in emotional recognition, and impairments in decision-making processes. In parallel, biological variables have also been identified, such as altered physiological responses to emotional or drug-related stimuli, dysfunctions within the reward system, and abnormalities in neural circuits involved in self-control and emotional regulation.
Although current interventions have demonstrated effectiveness in reducing substance use, important limitations remain regarding long-term relapse prevention, treatment adherence, and the internalization of therapeutic learning. Many socially vulnerable youths exhibit low treatment motivation, difficulties generalizing coping strategies to real-life situations, and limited engagement with conventional therapeutic approaches.
In this context, emerging technologies represent a promising avenue for enhancing psychological interventions targeting vulnerable adolescent populations. In particular, Virtual Reality (VR) enables the development of immersive, interactive, and therapist-controlled environments, facilitating safe exposure to high-risk situations as well as the training of emotional and behavioral skills within ecologically valid contexts. VR constitutes a non-invasive technology capable of recreating real-life environments in a standardized, controlled, safe, and adaptable manner according to patients' clinical needs.
Accordingly, the present study proposes the implementation of VR software aimed at treating addictive behaviors in youths experiencing social conflict. Following the development and validation of the virtual environment, a structured intervention program will be conducted, including several therapeutic and assessment modules. In the initial phase, objective measures will be obtained regarding: (1) emotional recognition; (2) avoidance and approach responses to substance-related stimuli; (3) susceptibility to social pressure and conformity; and (4) craving levels induced by exposure to drugs, conditioned cues, and substance-related contexts.
Participants will subsequently be randomly assigned either to a VR intervention group or to a Treatment As Usual (TAU) control group. Psychological and physiological variables will be assessed using standardized instruments before and after the intervention. Participants in the experimental group will be assessed one week before the experimental session and one week after; participants in the TAU group will undergo the same assessments at the same time, but will not participate in the experimental session in between.
During the experimental session, participants will also be assessed before and after the tasks involving the goggles and will undergo a protocol for measuring physiological parameters during the session itself, as detailed in the "Measurements" section.
It is hypothesized that the incorporation of VR into conventional treatment will enhance therapeutic outcomes by improving emotional regulation, reducing craving, increasing treatment adherence, and decreasing relapse risk compared to the control condition.
The findings derived from this research project may contribute substantially to improving clinical approaches for substance use disorders and dual pathology among adolescents and young people experiencing social conflict, while also providing innovative evidence-based therapeutic tools specifically adapted to the needs of this high-risk population.
67 studies on the registry are indexed under Antisocial Personality Disorder; 10 are open to participants now.
This study's planned enrollment of 50 is below the median of 140 across 43 interventional studies indexed under Antisocial Personality Disorder.
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Exclusion Criteria:
Participants receive treatment as usual plus one VR session. This arm includes VR to practice emotion recognition, and management of risk situations for substance use.
Behavioral: Virtual Reality
Participants receive treatment as usual, no other additional intervention.
Behavioral: Treatment as Usual (TAU)
This group will undergo a 1 individual session with a Virtual Reality program targeting emotion recognition, training on avoidance-approximation to associated stimuli, and exposure to conditioned contexts for substance use. During this session, participants will train specific abilities throug various activities. The tasks have been designed as a serious game in a Virtual Reality setting and include: emotion identification and recognition, practicing avoidance of conditioned substance use stimuli, and approximation to neutral stimuli, and exposure to conditioned situations to train regulation and management abilities for craving.
Participants in this group will receive treatment as usual provided by the facility, with no additional intervention. Treatment will be delivered ober the same period of time as in the other study group. Participants will complete one baseline assessment before the study period, and one post-intervention assessment.
Self-Efficacy for Drug Taking measured with Drug-Taking Confidence Questionnaire (DTCQ-8)
The Drug-Taking Confidence Questionnaire (DTCQ) measures the self-efficacy of individuals regarding their ability to resist drug use.
Time frame: Baseline (pre-intervention), Intervention (pre-post), Post. Up to 12 weeks
Inventory of Callous-Unemotional Traits (ICU)
The ICU is a self-reported, 24-item questionnaire that includes three subscales: Callousness (lack of empathy and remorse, callous use of others), Uncaring (lack of concern about performance and other's feelings), and Unemotional (reduced emotional expression and shallow affect). Each item is rated on a 4-point Likert scale from 0 (not true at all), to 3 (definitely true).
Time frame: Baseline (pre-intervention)
Alcohol use measured with the Alcohol Use Disorders Identification Test (AUDIT)
The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item self-report questionnaire developed by the World Health Organization to screen for hazardous and harmful alcohol consumption. Items are rated on a Likert-type scale and total scores range from 0 to 40, with higher scores indicating greater risk of problematic alcohol use.
Time frame: Baseline (pre-intervention)
Cannabis use measured with the Cannabis Abuse Screening Test (CAST)
The Cannabis Abuse Screening Test (CAST) is a self-report questionnaire consisting of 6 items designed to assess problematic cannabis use. Items are rated on a Likert-type scale and total scores range from 0 to 24, with higher scores indicating greater risk of problematic cannabis use.
Time frame: Baseline (pre-intervention)
Impulsive behavior measured with the UPPS-P short version
The UPPS-P Impulsive Behavior Scale consits of 20 items that measure five distint impulsivity traits: negative urgency, lack of premeditation, lack of perseverance, sensation seeking, and positive urgency. The scale is scored on a 4 point Likert scake, ranging from 1 (strongly agree) to 4 (strongly disagree).
Time frame: Baseline (pre-intervention)
Trait Anxiety measured with the State-Trait Anxiety Expression Inventory (STAI)
The State-Trait Anxiety Expression Inventory (STAI) measures two dimensions of anxiety: anxiety state, that reflects a transitory emotional response to specific situations, and anxiety as trait, the stable and generalized trend to experience anxiety. It is a 40 items scale, divided in two scales of 20 items each.
Time frame: STAI-Trait: Baseline (pre-intervention). STAI-STATE: Intervention (pre-post)
Motivation to quit using measured by Motivation Test to Quit-Richmond
The Motivation Test to Quit-Richmond assesses the level of motivation to quit smoking or drinking. It is a 4 items test with scored options. The total score indicates whether the motivation to quit using is none, low, moderate, or high.
Time frame: Baseline (pre-intervention), Post. Up to 12 weeks.
Craving using an Analogue Craving Scale
The analogue craving scales, ranging for 0-10, measures the participants' desire to use at a given time.
Time frame: Baseline (pre-intervention), Intervention (pre-post and during tasks). Up to 12 weeks
Motion sickness to VR measured with Simulator Sickness Questionnaire (SSQ)
The SSQ assesses cybersickness, which is the adverse symptoms associated with the use of VR. The questionnaire contains 16 symptoms of simulator sickness that rate from none to severe.
Time frame: Intervention (post). Up to 12 weeks
Presence in VR measured with Multimodal Presence Scale (MPS)
The MPS identifies three dimentios for presence in virtual environments: physical, social, and self-presence. The scale consits of 15 items with a five-point Likert scale ranging from 1 (completely disagree), to 5 (strongly agree).
Time frame: Intervention (post)
Salivary cortisol levels
Physiological stress response will be assessed through salivary cortisol levels obtained using saliva collection devices (Salivette, Sarstedt). Cortisol is a hormone released in response to stress and reflects activation of the hypothalamic-pituitary-adrenal (HPA) axis. Saliva samples will be collected before the task, immediately after the task, and 15 minutes after the task during both the initial and final assessments. Unit of measure: μg/dL. Higher cortisol levels indicate greater physiological stress response.
Time frame: Intervention (pre-task, immediately post-task, and 15 minutes post-task)
Salivary alpha-amylase activity
Autonomic stress response will be measured through salivary alpha-amylase activity, collected using saliva sampling devices (Salivette, Sarstedt). Alpha-amylase is a biomarker of sympathetic nervous system activation and is commonly used as an indicator of acute stress reactivity. Samples will be obtained before the task, immediately after the task, and 15 minutes after the task during both the baseline and final assessments. Unit of measure: U/mL. Higher values indicate greater sympathetic activation.
Time frame: Intervention (pre-task, immediately post-task, and 15 minutes post-task)
Salivary testosterone levels
Salivary testosterone levels will be assessed as a biomarker associated with physiological activation during anger-inducing tasks. Saliva samples will be collected using Salivette devices (Sarstedt) before the task, immediately after the task, and 15 minutes after the task during both baseline and final assessments. Testosterone concentrations will be expressed in pg/mL. Changes in testosterone levels will be examined to evaluate physiological responses associated with emotional activation.
Time frame: Intervention (pre-task, immediately post-task, and 15 minutes post-task)
Resting heart rate
Heart rate will be recorded using a Polar H10 heart rate monitor. Participants will undergo a 5-minute resting recording during both baseline and final assessments. Heart rate provides an indicator of physiological activation and autonomic nervous system activity. Unit of measure: beats per minute (bpm). Higher values indicate greater physiological arousal.
Time frame: Intervention (5 minutes post-task), Post for control group (5 minutes). Up to 12 weeks.
Heart rate variability (RMSSD and SDNN)
Heart rate variability (HRV) will be derived from ECG signals recorded with a Polar H10 heart rate monitor and analyzed using Kubios HRV software. HRV indices will include RMSSD (root mean square of successive differences) and SDNN (standard deviation of normal-to-normal intervals). HRV reflects autonomic nervous system functioning. Higher HRV values generally indicate greater parasympathetic activity and better autonomic regulation.
Time frame: Intervention (during tasks). Up to 12 weeks.
Frontal and temporal cortical activity measured with EEG
Cortical activity will be recorded using a Muse 2 electroencephalography (EEG) device with four dry electrodes. EEG signals will be collected during a 5-minute resting recording at baseline and post-intervention. Relative spectral power will be calculated for the main frequency bands (delta, theta, alpha, beta, and gamma). These measures reflect neural activity associated with cognitive processing and emotional regulation.
Time frame: Intervention (during tasks, post-tasks - 5 minutes resting), Post-control group (5 minutes-resting). Up to 12 weeks.
Plan to share: No — Individual participant data will not be shared publicly due to the highly vulnerable nature of the study population, which consists of minors (aged 13-21 years) under judicial custody. The data collected are sensitive and include mental health information, psychophysiological measures, and records of aggressive behavior within the juvenile justice system. Informed consent signed by participants and their legal guardians restricts data use to the research teams of Universidad Francisco de Vitoria and GINSO. Restricting data access ensures compliance with data protection regulations (GDPR and Spanish data protection law) and protects participants' privacy. In line with the principle of responsible openness, study results will be disseminated in aggregated and anonymized form. Any exceptional access to anonymized data would require a justified request to the Principal Investigator and evaluation under scientific, ethical, and legal criteria.
Started Dec 2025 (actual). Primary completion is estimated for Oct 2026, 10 months after the start.
Of 25 interventional studies with no phase under Antisocial Personality Disorder, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 66. This study's planned 10 months is below that.
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