Virtual Environment With Biofeedback to Promote Awareness of Relapse Risk Among Chemically Dependent Individuals
Condition: Anxiety
MeSH terms: Recurrence
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      2.4 Testing Protocol Prior CDI to the test, the therapist answered a questionnaire
      identifying the situations of risk presented in the VE that could lead the patient to
      relapse. The same questionnaire was also completed by the CDI before and after the VE test.
      In addition, this application was structured based on risk factors survey.

      The questions presented are listed below:

        1. If you receive a phone call from a friend that is a drug user, would it stimulate you to
           take drugs?

        2. If you walk on places that used to be selling drugs areas, would you relapse by any
           chance?

        3. If a colleague invites you to have drinks, would you be favored by taking drugs?

        4. Family issues or situations where the family is absent, would it contribute to your
           relapse?

        5. Would you relapse if you had the chance of going party or places that might have drugs?

        6. A friendship that is a drug user and can offer it to you would trigger your wishes for
           having drugs? The questionnaire and VE test were applied to each CDI in a single day on
           mornings. The patients were present with their therapists while performing the test.

      The test was conducted in a comfortable room that was part of a therapeutic community for
      CDIs. This room held the test equipment, a support table for the equipment, and chairs for
      the patient and therapist. Communication during the test was not recommended. Extra care was
      taken to avoid tests' interruptions including disturbance caused by equipment (air
      conditioning, audio, etc.) as well as people entering at the exam room. Regarding the
      sensors, the cardiac frequency meter was placed on the distal phalanx of the little finger
      and the respiratory rate (RR) sensor near the right nostril using a headset support. The CDIs
      were informed that the outcome of each situation presented in the VE would correspond to
      their physiological state when facing the risk situations. Their questions were answered, and
      only their emotions were shown to influence the scenarios. The test started with the
      volunteers watching a desired film selected by themselves where the basal levels from both
      physiological signals were simultaneously acquired. It was followed by the introduction of
      the developed VE where both heart and respiratory rates were measured between minutes and
      compared with the previously acquired baseline levels. The script automatically selected the
      scenes depending on the identified emotional state. When the state was identified as anxious,
      the program changed the scene, showing the character using drugs. Otherwise, the plot
      proceeded.
    

Intervention name(s): Heart and respiratory rate and VE; Heart and respiratory rate and video
Intervention type(s): Device; Device
Intervention description(s): To evaluate the effectiveness of the virtual environment (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.; Anxiety is characterized by the average variability from both heart and respiratory rate of 30 volunteers undergoing stress environment situations.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Anxiety