To identify if, how and when VR is of added value in current treatment methods for people with SAD and MBID.
ID
Source
Brief title
Condition
- Other condition
Synonym
Research involving
Sponsors and support
Intervention
- Medical device
N.a.
Outcome measures
Primary outcome
<p>Virtual Reality can potentially lead to a better understanding of one's risk<br>situations and triggers, and the generalization of coping strategies to daily<br>life. This is assumed to increase client's self-efficacy in coping with their<br>substance-related and addictive disorder. Therefore, self-efficacy is measured as the primary<br>outcome measure.</p>
Secondary outcome
<p>As secondary outcome measures self-insight into triggers for SAD and adopted<br>coping strategies for SAD are measured. Both primary and secondary outcome<br>measures could potentially explain the added value of VR for clients.<br><br>Other secondary outcomes of the study are:<br>- To gain insight in experienced benefits, barriers, points of improvements and<br>suggestions from therapists on working with VR in addiction treatment.<br>- To gain insight in clients* experienced benefits, barriers, points of<br>improvements and suggestions on using VR during their addiction treatment.<br>- Investigate if there is a positive increase over time in self-reported<br>insight and self-efficacy levels by clients after the introduction of VR in<br>their treatment.<br>- Investigate whether the level of detail in describing and adopting coping<br>strategies by participants increases over time and can potentially be<br>attributed to the VR sessions.</p>
Background summary
People with low cognitive and adaptive abilities are more susceptible to
develop a substance-related and addictive disorder (SAD). While adapted cognitive behavioural
therapy (CBT) protocols, such as CBT+, have been developed to accommodate this
vulnerable user group, these protocols still heavily rely on the capacity to
reflect on and talk about behaviour and the generalization of skills that were
discussed in the treatment room. This presents a significant challenge for
individuals with mild to borderline intellectual disabilities (MBID). Virtual reality (VR) is a
suitable tool to overcome these shortcomings, by offering an immersive
environment in which patients can experience and learn to recognize risk
situations and triggers in context, without having to rely on memory or
verbalization. Although VR is already sparsely used in addiction treatment,
little is known about how it can be integrated in existing treatment, if and
how it is of added value for current SAD treatment programs, and during which
phase of treatment VR should be offered.
Study objective
To identify if, how and when VR is of added value in current treatment methods
for people with SAD and MBID.
Study design
In this study, a multiple baseline SCED with two conditions will be deployed,
where participants will follow their regular CBT treatment (A phase) and
additionally will receive VR either in the beginning (assessment phase) or the
middle (practice phase) of their treatment (B phase). Both conditions start
with a baseline of two weeks where participants follow TAU (i.e. one treatment
session per week). After two weeks, participants in condition 1 will start
using VR in their regular treatment for three weeks (week 3-5) and follow their
TAU again after these three weeks (in week 6). Participants in condition 2 will
start using VR in their regular treatment after 6 weeks of TAU, receiving VR
sessions in week 7 to 9 of their treatment program. Each participant thus
receives a total of three VR sessions in their TAU.
By introducing VR at different times in TAU, it is possible to investigate when
VR is of most added value for the patients. At the same time, this study
investigates whether the added value of VR for people with ID lays in gaining
insight into triggers and risk situations and / or learning and practicing
coping skills. A mixed-method approach will be used in which both quantitative
as qualitative measures will help in answering the research questions. Because
a SCED requires repetitive measurements over time, participants will
continuously be monitored throughout the duration of their treatment of 12
weeks by using the experience sampling method (ESM) and questionnaires after
each treatment session.
Intervention
The intervention consists of using VR scenarios in different parts of the
treatment to support the patient in their understanding of- and coping with
their SUD. For this purpose the hard- and software of CleVR will be used as an
intervention tool. CleVR is CE-certified as a medical device and is specialised
in developing evidence-based VR environments for the treatment of mental health
disorders. CleVR offers several VR environments identified as possible risk
situations for people with SUD, such as a supermarket, a living room or a pub.
In this SCED, participants in condition 1 will explore potential triggers and
risk situations in VR. Together with the client and based on the individual
needs of the client, the virtual environments will be personalised by the
therapist to resemble risk situations recognizable by the client (e.g. adding
specific triggers related to the substance used or the gambling behaviour by the client). The focus will
be on identifying personalized risk factors that are relevant for an individual
patient*s substance use or gambling behaviour (*triggers*, including e.g. situations and social
interactions). To support the therapist flashcards will be available with
guidelines on how to personalize VR environments together with their client.
Also example questions are given on how the therapist can help the client in
gaining more insight into their triggers and risk situations in VR. It is
emphasized that the number of triggers and the degree of stress in risk
situations for the client should be gradually increased, in order to let the
client get used to being in VR (i.e. starting in a VR environment that is
comfortable for the client with little to no triggers, and gradually adding
triggers to the environment or switching to more exciting environments).
Participants in condition 2 will use the VR environments to practice coping
strategies discussed in TAU, such as keeping distance or asking for help. VR
templates (e.g. home environment where a party is given, buying alcohol in a
supermarket, home environment with a computer) are available to the therapist in which a specific coping strategy can be practiced. Flashcards describing example exercises for each VR template
are available to the therapist. Each flashcard offers an introductory and an
advanced practice to be performed in VR, so the practice can be adapted to the
needs and skills of the client.
Study burden and risks
Load of study participation
Participants follow treatment-as-usual (TAU) for their SAD, where VR is either
integrated in the beginning (i.e. week 3-5) or middle (i.e. week 7-9) of their
treatment. In each condition participants partake in three VR sessions in
total. Existing CBT exercises are replaced with similar exercises in VR. Due to
this integration, treatment sessions will have the same duration as before
(between 30-45 minutes). For the purpose of this study, treatment session will
be lengthened with 5 minutes to administer the after session questionnaires,
which is done by the therapist to keep things efficient. The experience
sampling questionnaires will substitute paper and pencil homework exercises in
TAU. Hence, only participation in the intake and interviews will require some
substantial additional time investment of participants, each lasting a maximum
of 45 minutes. The study intake and interviews will focus mainly on the
experiences of the participants during treatment. We do not expect discomfort
or psychological burden from these study activities.
Risks associated with participation
The VR intervention has the potential to incur some discomfort to the
participants, including slight disorientation and motion sickness (i.e.
cybersickness). However, these disadvantages are minimized by exclusion of
participants with prior motion sickness, and continued monitoring of
participants while experiencing VR and introducing them gently back into the
real world after the VR session. Therapists are trained to recognize discomfort
in participants, to intervene appropriately and if necessary withdraw the
participant from the study.
Participants are exposed to potential triggers in VR related to their SAD,
which could lead to an increase in craving. This is a normal experience in
patients recovering from SAD (as increase in craving also appears during TAU
while talking about SAD), and if done well, is beneficial for treatment since
it allows them to gain insight in triggers and practice with coping strategies.
Health care professionals are trained to notice this craving and offer coping
strategies to the client when needed, as they do in TAU.
Benefits of participation
Possible benefits for participants could include more insight into their SAD
and triggers and generalization of learned skills in VR to the real world.
Additionally, VR integrated CBT+ potentially fits the needs of this vulnerable
user group better than TAU, offering a more practical and pleasurable treatment
experience.
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
Participants will be included in the study when:
- They voluntary want to participate in the study and can give informed consent
- They are 18 years or older
- Follow a CBT program, such as *Minder Drank of Drugs*, for individuals with
mild Intellectual Disability (MID) or Borderline Intellectual Functioning (BIF),
and Substance-related and addictive disorders (SAD; e.g. substance use disorder, gambling disorder).
- They have a sufficient understanding of the Dutch language and are able to
answer simple questionnaires, whether or not with some extra help of the
researcher / therapist
- They are in possession of a smartphone on which they can (either
independently or with some help) download the experience sampling app
Exclusion criteria
- If there are any conditions that precludes potential participants from
participating in an outpatient CBT+ program (e.g. severe current psychiatric
co-morbidities)
- If clients have a known history of epilepsy or severe motion sickness, or
show signs of severe motion sickness during the VR try-out.
- If clients are under the supervision of a legal custodian or mentor and are
unable to provide informed consent.
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL86695.091.24 |
Research portal | NL-005584 |