Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06315660 |
| Other study ID # |
P-2021-627 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2024 |
| Est. completion date |
April 2026 |
Study information
| Verified date |
March 2024 |
| Source |
Mental Health Centre Sct. Hans |
| Contact |
Benjamin Arnfred, phd |
| Phone |
31724603 |
| Email |
barn0006[@]regionh.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Dual diagnosis refers to patients with both severe mental illness and substance abuse. Dual
diagnosis is therefore a challenging condition to treat, and the group typically represents
the most vulnerable individuals in society. Historically, research on dual diagnosis has been
underprioritized, and thus, we still do not know enough about how to best assist this
vulnerable group.
However, new studies indicate that virtual reality programs can reduce anxiety in patients
with psychotic disorders. They achieve this by providing access to a virtual therapist and
lifelike environments where patients can challenge their thoughts about the dangers of
navigating the world. For both psychotic disorders and substance abuse, we know that anxiety
often plays a role in the clinical picture. Therefore, anxiety almost always has an impact on
dual diagnosis patients, where it is crucial in maintaining substance abuse and functional
impairment. Despite this, anxiety is rarely a focus in existing treatment options, as it is
too resource-intensive in addition to an already intensive treatment process.
This study investigates whether the resource barrier can be overcome and whether hospitalized
dual diagnosis patients can experience reduced anxiety, fewer relapses, and better outcomes
after discharge when their anxiety is treated through partially automated virtual reality
therapy.
Description:
Introduction - Dual diagnosis (i.e., comorbid psychosis and substance use disorder) is
characterized by more severe psychopathology, higher morbidity, less treatment adherence, and
smaller treatment gains compared to psychosis alone. Further, there is a clear association
between educational status and both prevalence and mortality of psychosis and substance use.
Thus, the debilitating symptoms of these disorders propagate social inequality as well as
being a substantial societal burden in purely economic terms. Importantly, this burden seems
to increase when patients cannot access evidence-based treatment and recent policy changes
mean that the amount of dual diagnosis patients in the Danish mental health services will
soon more than triple. Improving the accessibility and efficacy of treatment for this
vulnerable population is therefore more than ever, a critical unmet need. For this reason,
this study aims to investigate the feasibility, efficacy, and acceptability of a partially
auto-mated virtual reality (VR) based psychotherapeutic intervention targeting anxiety in
dual diagnosis patients. Social avoidance has been theorized to be a highly relevant
treatment target in dual diagno-ses populations since it is thought to play a critical role
in maintaining symptoms, worsening mood and functional impairment, and deteriorating
treatment adherence. Recent studies have found that VR-based cognitive behavioral therapy for
psychosis (CBTp) resulted in significant reductions in anxiety and psychotic symptoms, while
being safe and acceptable. Studies also show that this treatment can be automated, thus
greatly increasing accessibility of treatment. Further, automatiza-tion allows patients to
continue treatment even after hospital discharge, potentially maintaining treatment gains for
longer. In short, there are several findings which indicate that automated VR-based CBTp is a
promising treatment for dual diagnosis and therefore this present trial will be the first in
the world to investigate this.
Background - Though CBTp has been shown to be an effective and safe treatment that patients
prefer to medication, it is still poorly implemented in many countries. Only 0.07 % of the
5.5 billion DKK that schizophrenia costs Danish society yearly, are related to contacts with
a psychologist or psychiatrist, implying that CBTp is also poorly implemented in Denmark. For
dual diagnosis patients, prospects of receiving CBTp are further complicated because
hospitals offering CBTp often forward patients with comorbid SUD to municipal services. In
addition, the evidence supporting psychotherapy for dual diagnosis is still inadequate and
the long-term effect of treat-ment remains unclear. This is likely because psychotherapy can
be difficult to access for dual diag-nosis patients, being a long-term and complex
intervention, which requires a high level of competence from the administering clinician. The
lack of high quality clinical research, along with the complexity of the treatment, represent
major barriers for implementation. Incorporating the use of VR technology in high quality
clinical research may be one way to develop CBTp towards be-coming more accessible, increase
long term efficacy and address anxiety symptoms, and easier to implement.
