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

NCT02535858 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-08-31

No results posted yet for this study

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

Interventions

DEVICE

Heart and respiratory rate and VE

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.

DEVICE

Heart and respiratory rate and video

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

Sponsors & Collaborators

  • University of Mogi das Cruzes

    lead OTHER

Principal Investigators

  • Annie F. Frère, PhD · University of Mogi Cruzes

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2007-12-31
Completion
2008-05-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02535858 on ClinicalTrials.gov