Virtual Environment With Biofeedback to Promote Awareness of Relapse Risk Among Chemically Dependent Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percentage of the variation in respiratory and heart rate.
研究概览
简要总结
Anxiety is one of the major influences on relapse and substance abuse treatment dropout. Chemically dependent individuals need to be aware of their emotional state in situations that jeopardise their treatment. The current therapeutic resources still subjective and with limited treatment success. This research presents a developed virtual environment (VE) simultaneously connected to a physiological signals device acquisition that allows, through a biofeedback, the chemically dependents consciousness on their vulnerability front different situations of 'risk', without a direct assessment of the therapist. Developed in 3ds Max® software, the VE is composed of scenarios and objects that are in the habit of the chemically dependent individual's daily life. The interaction with the environment is accomplished using a Human-Computer Interface (HCI) that converts incoming physiological signals indicating anxiety state into commands that change the scenes. Anxiety is characterized by the average variability from both heart and respiratory rate of 30 volunteers undergoing stress environment situations. To evaluate the effectiveness of the VE as a biofeedback of chemically dependent's vulnerability front situations of risk, a total of 50 volunteers who were drug users, monitored by 10 therapists, were enrolled. Prior VE, the results demonstrated a poor correlation between the therapists' predictions and those of the chemically dependent individuals. After exposure to the VE, there was a significant increase of 73% in awareness of the risks of relapse by the chemically dependent individuals, confirming the hypothesis that the VE coupled to the biofeedback device may assist the therapist with treatment.
详细描述
2.1 Ethical approval Approval was obtained from the Local Ethics Committee (CAAE-0094.0.237.000-07, process CEP/UMC-093/2007) for the participants. They had been informed about the methodology and confidentiality of their personal information. The participants were informed about the methodology and confidentiality of their personal information. All procedures were performed after written informed consent from all participants.
2.2 Study Participants To determine the limits between normal and emotional anxious, thirty volunteers male's adults (GL) with age range between 20 and 50 years were recruited. None of them had any pathology associated with anxiety or psychiatric disorders, and none was drugs user or taking medication. Three mental health professionals (PG1), specialized in chemical dependency, evaluated the emotional state of the volunteers.
A second group has fifty adult volunteers (DG) (mean age of 35±10.02 years) ongoing outpatient chemical dependency clinic [treatment average's population: 5 months and 14 days]. The patients were abstained from drugs use for at least two months, and they were selected to test the VE. None of the DG's participants had any pathology associated with anxiety or psychiatric disorders, and none was taking medications. The DG volunteers were narcotic users of two or more illicit drugs, such as alcohol, marijuana, tobacco, cocaine and crack cocaine. Addiction for alcohol and tobacco were 72% and 56% respectively. The group's percentage for using psychoactive drugs were, 70% for cocaine and crack cocaine and 32% for marijuana.
For this group, 10 mental health professionals (PG2), therapists, specialized in chemical dependency and responsible for monitoring the group's treatment assessed their emotional states.
To elaborate the scenarios and characterize the characters in the virtual environment (VE), another eight specialists professionals (PG3) from the chemical dependency field recommended situations, places, objects, signs, or cues thought to trigger craving.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Volunteers (DG) ongoing outpatient chemical dependency clinic [treatment average's population: 5 months and 14 days].
- •The patients were abstained from drugs use for at least two months, and they were selected to test the VE.
- •None of the DG's participants had any pathology associated with anxiety or psychiatric disorders, and none was taking medications.
- •The DG volunteers were narcotic users of two or more illicit drugs, such as alcohol, marijuana, tobacco, cocaine and crack cocaine.
排除标准
- •The patients were not abstained from drugs use for at least two months
研究组 & 干预措施
Heart and respiratory rate and video
To determine the limits between normal and emotional anxious, thirty volunteers male's adults (GL) with age range between 20 and 50 years were recruited. None of them had any pathology associated with anxiety or psychiatric disorders, and none was drugs user or taking medication.
干预措施: Heart and respiratory rate and video (Device)
Heart and respiratory rate and VE
A second group has fifty adult volunteers (DG) ongoing outpatient chemical dependency clinic [treatment average's population: 5 months and 14 days]. The patients were abstained from drugs use for at least two months, and they were selected to test the VE. None of the DG's participants had any pathology associated with anxiety or psychiatric disorders, and none was taking medications. The DG volunteers were narcotic users of two or more illicit drugs, such as alcohol, marijuana, tobacco, cocaine and crack cocaine. Addiction for alcohol and tobacco were 72% and 56% respectively. The group's percentage for using psychoactive drugs were, 70% for cocaine and crack cocaine and 32% for marijuana.
干预措施: Heart and respiratory rate and VE (Device)
结局指标
主要结局
Percentage of the variation in respiratory and heart rate.
时间窗: The respiratory and heart rate were collected during 10 minutes from each no-drugs user and 30 minutes from each chemically dependent individual.
This research presents a developed virtual environment (VE) simultaneously connected to a physiological signals device acquisition (heart and respiratory rates) that allows, through a biofeedback, the chemically dependents consciousness on their vulnerability front different situations of 'risk', without a direct assessment of the therapist. During the virtual exposure, the heart and respiratory rates of the chemically dependent individual (CDI) were acquired and processed to be classified as a normal or anxious state. Then, the scenes were automatically changed depending on the captured physiological signals. The signals' average were calculated for each individual and emotional state (normal vs. anxious). A volunteer was considered to be anxious if the heart or respiratory rates are at least 7% and 16% above the basal levels respectively.
次要结局
未报告次要终点
研究者
Annie France Frère Slaets
PhD
University of Mogi das Cruzes