Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315660
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-12
Brief Title:
VR Based Therapy to Treat Anxiety in Dual Diagnosis
Sponsor:
Mental Health Centre Sct Hans
Organization:
Mental Health Centre Sct Hans
Study Overview
Official Title:
Virtual Reality Cognitive Behavioral Therapy for Anxiety in a Dual Diagnosis Population A Randomized Clinical Trial Assessing Acceptance Feasibility and Preliminary Efficacy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Introduction - Dual diagnosis ie 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 007 of the 55 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
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 007 of the 55 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None