Virtual Environment With Biofeedback to Promote Awareness of Relapse Risk Among Chemically Dependent Individuals

NCT02535858 | Completed DMC

• 1 other identifier: 0094.0.237.000-07
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety

Keywords

Anxiety

Outcome Measures

Primary Outcomes (1)

• Percentage of the variation in respiratory and heart rate.

  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.

  The respiratory and heart rate were collected during 10 minutes from each no-drugs user and 30 minutes from each chemically dependent individual.

Study Arms (2)

Heart and respiratory rate and video

EXPERIMENTAL

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.

Device: Heart and respiratory rate and video

Heart and respiratory rate and VE

EXPERIMENTAL

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.

Device: Heart and respiratory rate and VE

Interventions

Heart and respiratory rate and VE DEVICE

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.

Heart and respiratory rate and VE

Heart and respiratory rate and video DEVICE

Anxiety is characterized by the average variability from both heart and respiratory rate of 30 volunteers undergoing stress environment situations.

Heart and respiratory rate and video

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• The patients were not abstained from drugs use for at least two months

Sponsors & Collaborators

• University of Mogi das Cruzes: lead

Study Sites (1)

University of Mogi das Cruzes

Mogi das Cruzes, São Paulo, 08780911, Brazil

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Respiratory Rate

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Annie F. Frère, PhD

  University of Mogi Cruzes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 31, 2015
• Study Start: November 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: May 1, 2008
• Last Updated: August 31, 2015

Record last verified: 2015-08

Locations

BR (1)