An interventional study of Cognitive Miljeu Therapy and Virtual Reality based CBT for Anxiety in Dual Diagnosis, Psychosis and Agoraphobia, sponsored by Mental Health Centre Sct. Hans. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Mental Health Centre Sct. Hans · Not applicable, Interventional, and Treatment
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.
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.
1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.
This study's planned enrollment of 30 is below the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.
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Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Cognitive Miljeu Therapy · Behavioral: Virtual Reality based CBT for Anxiety
Behavioral: Cognitive Miljeu Therapy
TAU is an integrated voluntary inpatient treatment based on the principles of CBT, lasting between 12-20 weeks. This treatment includes exercise, close medical monitoring, group-based CBT for SUD, planning with social services, and is called Cognitive Milieu Therapy.
The experimental intervention is a manualized add-on to TAU and comprises eight sessions of 60 minutes over a period of four weeks. Of these eight sessions, six will include 30 minutes of VR-based behavioral experiments targeting agoraphobic and social fear.
Oxford Agoraphobic Avoidance Scale
The Oxford Agoraphobic Avoidance Scale is a psychometrically validated short-form questionnaire designed specifically to assess anxious avoidance and distress in a population with psychosis
Time frame: From enrollment to 3 month post treatment (16.9 weeks)
Client Satisfaction Questionnaire
The Client Satisfaction Questionnaire is an 8-item scale loading to one factor of satisfaction with mental healthcare service.
Time frame: From enrollment to post treatment (4 to 8 weeks)
Systems Useability Scale
The System Usability Scale is a standardized questionnaire designed to provide a quick measure of the user's subjective perception of the usability of a computer system. It will be administered to clinical staff after treatment.
Time frame: From enrollment to post treatment (4 to 8 weeks)
Timeline Followback
• Timeline Follow Back (TLFB) will be used to measure alcohol and drug consumption the last three month at baseline, post-treatment, and follow-up. TLFB is systematic review of consumption every day for a specific period of time, with adequate psychometric qualities.
Time frame: From enrollment to 3 month post treatment (16.9 weeks)
The Six-item Positive and Negative Symptom Syndrome Scale
• The Six-item Positive and Negative Symptom Syndrome Scale (PANSS-6) will be used to measure change in psychosis symptom severity between baseline, post-treatment, and follow-up. PANSS-6 is a clinician administered 6-item scale designed to measure positive and negative symptoms in patients with schizophrenia. It has been translated and validated for a Danish population.
Time frame: From enrollment to 3 month post treatment (16.9 weeks)
The Social Functioning Scale
The Social Functioning Scale (SFS) will be used to measure changes in social functioning between baseline, post-treatment, and follow-up. The SFS is a widely used measure of impairment in functioning that has been psychometrically validated for populations with psychosis and translated to multiple languages, including Norwegian.
Time frame: From enrollment to 3 month post treatment (16.9 weeks)
The Questionnaire about the Process of Recovery
The Questionnaire about the Process of Recovery (QPR) will be used to measure changes in the experience of recovery between baseline, post-treatment, and follow-up. QPR has been translated to several languages, including Swedish, and has acceptable psychometric properties in term of reliability and validity.
Time frame: From enrollment to 3 month post treatment (16.9 weeks)
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