INTERSTRESS - Interreality in the Management and Treatment of Stress-related Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- psychophysiological measures (heart rate and heart rate variability indexes)
研究概览
简要总结
Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. In this view, stressful experiences are conceptualized as person-environment transactions, whose result is dependent on the impact of the external stimulus. This is mediated by the person's appraisal of the significance of the stimulus, of the personal, social and cultural resources available and of the efficacy of the coping efforts.
Extreme levels of stress can have a negative influence on one's professional life and can disrupt both the social and personal life of an individual. Stress can also cause different physiological and psychological disorders such as anxiety, chronic headaches, depression, withdrawal symptoms, nausea, phobias, blood pressure problems, heart impairments and others.
Stress Management Therapy can help to overcome counter effects of stress. Usually various techniques are used including relaxation, interaction, biofeedback and Cognitive Behavior Therapy methods. According to the Cochrane Database of Systematic Reviews the best validated approach covering both stress management and stress treatment is the Cognitive Behavioral Therapy (CBT) approach.
The trouble with stress is that it is very personal. Thus, stress-related disorders depend a great deal on how the person experiencing a stressor is put together -psychologically and physically. So the focus for assessment, prediction and treatment has to be the person's situated experience.
To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health - Interreality - that integrates contextualized assessment and treatment within a hybrid environment, bridging physical and virtual world.
From the clinical point of view the INTERSTRESS solution may offer the following innovations to current traditional protocols for stress management:
- Objective and quantitative assessment of user's stress level using biosensors and behavioral analysis;
- Provision of warnings and motivating feedbacks to improve self awareness, compliance and long term outcome;
- Decision Support System (DSS) for treatment planning through data fusion and detection algorithms.
详细描述
The present trial is based on a randomized controlled study. We will recruited at least 100 participants, that will be split into two groups of at least 50 subjects who suffer from psychological stress: 1) the experimental group 2) the control group. Participants included in the experimental condition will receive a treatment based on cognitive behavioral techniques combined to virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as qualitative dependent variable.
Different settings are planned for the training: Clinical, Home and Mobile Setting.
Following, a description of the protocol in details, both for the experimental and the control group, in the three different settings.
- In the experimental condition, participants will first take part to an intake session with the introduction to the training (clinical setting) and to an assessment week to detect stressful situations in daily life through portable biosensors and a smart phone (home setting); then they will be exposed to an assessment session for detecting the psycho-physiological variations occurred during the different stressful environments exposure (clinical setting).
Afterwards, participants will receive a training for psychological stress management based on cognitive behavioral techniques combined to virtual reality, biofeedback and mobile phone. The training will be structured into ten sessions (two per week, each one lasting about one hour), which will be divided into four parts:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual who suffer from psychological stress;
- •Age between 25 and 60 years.
排除标准
- •DSM_IV-TR Axis I disorders;
- •history of neurological diseases, mental retardation, psychosis, alcohol or drug dependence;
- •psychotherapy received for their psychological stress;
- •pharmacotherapy received for their psychological stress;
- •migraine, headache, or vestibular abnormalities.
研究组 & 干预措施
A treatment based on CBT and new technologies
Individuals will receive a treatment based on cognitive behavioral therapy and new technologies (virtual reality, virtual reality combined to biofeedback and mobile phones). Relaxation will be induced through the immersion in different virtual environments (e.g., lake) which will be customized with different pre-recorded audio narratives that describe the specific setting and that guide the execution of a series of relaxation exercises. During biofeedback exercises a wearable biosensor system will provide suggestions to the trainer based on the reactions of the participants, and the biosensor data will directly modify the virtual reality experience in real time.
干预措施: Coping skills and relaxation training with new technologies (Behavioral)
Traditional treatment based on CBT
Participants will receive a treatment based on traditional cognitive behavioral therapy techniques for stress management, without the use of new technologies. Relaxation will be induced by guided imagery, through auditory narratives.
干预措施: Traditional coping skills and relaxation training (Behavioral)
结局指标
主要结局
psychophysiological measures (heart rate and heart rate variability indexes)
时间窗: 5 weeks
quality of life questionnaire
时间窗: 5 weeks
Level of psychological stress measured by psychometric questionnaires (PSM, PSS, COPE, PSQI, SWLS, STAI)
时间窗: five weeks
Treatment duration is 5 weeks. Outcome measures are assessed before and after treatment and at follow-up (18-month).
次要结局
未报告次要终点
研究者
Giuseppe Riva
Scientific coordinator
Istituto Auxologico Italiano