This preliminary quasi experimental study aims to explore the experiences of patients using a newly developed VR application as an adjuvant in the treatment of AUD after clinical detoxification in DSM-5 diagnosed AUD patients. This study aims to…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
verslaving namelijk stoornissen in alcoholgebruik
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In the present study a quasi-experimental study is proposed. This study
provides more insights in the experience and acceptance of the use of an
VR-application as an adjuvant in the inpatient treatment of AUD patients. The
main study parameter is the experience and acceptance to use a VR app by AUD
patient in an inpatient treatment program.
Secondary outcome
Furthermore the study will focus on the level of realism, operationalized in
two different types of VR environments (360° recordings versus computer
generated virtual worlds) that is experienced by the participants. In addition,
the satisfaction and side effects as the level of self-efficacy and of craving
experienced by the participants will be measured. The last two will be measured
before and immediately after the VR-sessions. The dmCV (a hybrid measure of the
SSQ and subjective symptoms of craving to differentiate from both) will be used
for the exploration before (first base line measure) and after the three
sessions. The satisfaction will be measured only after the last session.
Background summary
Rationale: Alcohol Use Disorder (AUD) is a tremendous health challenge that
affects the life of many people. For instance in the US over 15 million adults
deal with an AUD (2015) and over five percent of the burden of disease and
injury worldwide was attributable to alcohol consumption according WHO (WHO,
2012). Although treatment programs are available, about 6.7 percent received an
AUD treatment (NIH, 2018). Treatment remains a challenge. According to Dutch
research between 47-75% of AUD patients relapse in the first year after
clinical detoxification (Snelleman et al., 2018). New digital technologies,
such as Virtual Reality (VR), provide potential adjuvant treatment
possibilities for AUD patients. VR is understood as an environment consisting
of a mediated observation of solely virtual (digital) objects. It immerses
users into virtual worlds as a multisensory and interactive experience, often
supported by stereoscopic images, sound and body tracking (van Gisbergen,
2016). While being in the virtual world, the user feels a higher level of being
present in the other world. VR creates patient contexts that are difficult or
too expensive to simulate in clinics (Maples-Keller et al., 2017). Being in a
sheltered and empowering VR environment, patients can explore challenging
situations in a safe environment (Riva & Wiederhold, 2002). VR has successfully
been used in psychiatry and psychology treatment programs for PTSD, phobias,
and anxiety, but has not yet been developed and tested as an adjuvant tools in
the immediate-post-inpatient-detoxification AUD therapy program ((Bordnick et
al., 2008; Hone-Blanchet, et al. 2014; Ryan,et al., 2010; Son et al., 2015)).
Study objective
This preliminary quasi experimental study aims to explore the experiences of
patients using a newly developed VR application as an adjuvant in the treatment
of AUD after clinical detoxification in DSM-5 diagnosed AUD patients. This
study aims to provide more insight in the experience and acceptance of using a
VR-application in detoxification treatment. Furthermore, the study will focus
on the effect of VR realism, operationalized in two different types of VR
environments (360° recordings versus computer generated virtual worlds),
negative effects of VR, satisfaction, and the intuition to use (attitude)
towards the VR-intervention. In addition, the study will assess whether
patients will experience strengthening of self-efficacy to stay abstinent in
challenging and craving-induced environmental circumstances and the level of
craving. When the outcomes are positive and this newly developed VR-software
technology can be used by AUD DSM-5 patients and their therapists in the
immediate-post detoxification phase of an inpatient detoxification treatment
program, a larger RCT study on long term effects will be developed.
Study design
it is an quasi experimental study that will compare three groups of 16
patients: (1) a group of AUD patients that will receive treatment as usual
(TAU); (2) a group of AUD patients that will be exposed to Computer Generated
Virtual reality environments and (3) a group of AUD patients that will be
exposed to the same environments but recorded in 360°. The patients will
receive VR as an adjuvant to the TAU AUD treatment in the last week of their
stay in the inpatient detoxification unit. They will receive 3 VR sessions at
day 1, 4 and 7. Prior to and immediately after each session patients will
complete self-rating outcome measures. After the final session they will be
asked to participate in an oral interview. The measurement instruments will
address: (a) the experience of using the VR-application in AUD treatment (e.g.,
the ITC-Sense of Presence Inventory (ITC-SOPI); (b) the intention to use of the
VR-application in AUD treatment (oral interview concerning (i) the
accessibility; (ii) the affordability; (iii) the perceived usefulness; (iv) the
perceived ease of use); (v) the motivation (c) possible VR negative effects
(e.g., using the Simulator Sickness Questionnaire (SSQ); (d) Self-efficacy
(using the Self-Efficacy scale for Drug Users-Revised (SELD-R); (e) and Craving
(using among others the Visual Analogue Scale (VAS)).
Intervention
In the last week of their inpatient detoxification program patients of both the
360° and animated VR groups will have three 30 minutes VR session (day 1,4 and
7) in which they will be confronted with four different environments based on a
general personal relapse prevention plan: a neutral environment, a green (safe)
environment, a yellow (home) environment and orange (bar) environment. Craving
levels and levels of self-efficacy will be measured prior and immediately after
each session as well measures concering the patients' VR experience of the
patients will be presented.
Study burden and risks
The patients burden will be the filling out of the questionnaires that will
take 10 minutes before and 10 minutes at the end of each session also the
session will take about 15 minutes. After the last session the patient will be
interviewed for about 25 min. Total the patients burden will be around 2 hours
and 10 min. In a pre-study patients were assessed in their
immediate-inpatient-detoxification period. They could get acquainted with a
forerunner of the VR -application and could address the side effects of
application. They indicated there were no side effects but instead of side
effects they experienced a high level of attraction because of a high fun
factor. So therefore we expect the burden and possible risks to be low.
Hoge dwarsstraat 3
Vught 5261 LX
NL
Hoge dwarsstraat 3
Vught 5261 LX
NL
Listed location countries
Age
Inclusion criteria
a) Primary dependence of alcohol, (b) Age between 18 and 65 years and (c)
Sufficient understanding of the Dutch language.
Exclusion criteria
(a) Severe psychiatric disorders like severe psychosis and suicidal ideations
(issues); (b) severe poly-drug use (in such a way that it interfers with the
treatment); (c) severe physical diseases (cardiovascular diseases, COPD
etc.),(d) mentally incompetent and (e) pregnancy.
Design
Recruitment
Medical products/devices used
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
CCMO | NL69690.029.19 |