Dual DiagnosisNCT06315660
VR Based Therapy to Treat Anxiety in Dual Diagnosis
A study testing Cognitive Miljeu Therapy and Virtual Reality based CBT for Anxiety in people with Dual Diagnosis and Psychosis, run by Mental Health Centre Sct. Hans.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dual Diagnosis, Psychosis, Agoraphobia
- What is being tested?
- Cognitive Miljeu Therapy and Virtual Reality based CBT for Anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (+18 years) admitted to the standard dual diagnosis treatment program in the Mental Health Services of the Capital Region of Denmark.
- Fulfilling diagnostic criteria for a F20-29 disorder and dependence syndrome of either alcohol or drugs in the ICD-10 diagnostic manual.
- Scoring 6 or above on the avoidance subscale and 66 or above on the distress subscale scale of the O-AS. This corresponds to severe levels of avoidance and distress36.
Who cannot join
- Incapable of providing informed consent.
- Insufficient knowledge of the Danish and/or English language.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Virtual Reality Cognitive Behavioral Therapy for Anxiety in a Dual Diagnosis Population: A Randomized Clinical Trial Assessing Acceptance, Feasibility, and Preliminary Efficacy
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.
Read the detailed 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.
- Being tested
- Cognitive Miljeu Therapy, Virtual Reality based CBT for Anxiety
- Medical subject headings
- Psychotic Disorders, Agoraphobia, Phobia, Social, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Miljeu TherapyBehavioural
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.
Virtual Reality based CBT for AnxietyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TAU+VR | Experimental | Not described Receives: Behavioral: Cognitive Miljeu Therapy; Behavioral: Virtual Reality based CBT for Anxiety |
| TAU | Active comparator | Not described Receives: Behavioral: Cognitive Miljeu Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: From enrollment to post treatment (4 to 8 weeks)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to 3 month post treatment (16.9 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study startNov 2024 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dual DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a parallel group, investigator initiated, pragmatic, assessor-blinded, 1:1 randomized, clinical feasibility trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Sct. Hans
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Benjamin Arnfred, phd, Principal investigator, Mental Health Centre St. Hans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315660
- Sponsor's protocol ID
- P-2021-627
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Cognitive Behavioral Therapy for Anxiety in a Dual Diagnosis Population: A Randomized Clinical Trial Assessing Acceptance, Feasibility, and Preliminary Efficacy
- ClinicalTrials.gov ID
- NCT06315660
- Acronym / sponsor ID
- P-2021-627
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mental Health Centre Sct. HansOther government
- Study start
- Nov 2024 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a parallel group, investigator initiated, pragmatic, assessor-blinded, 1:1 randomized, clinical feasibility trial.
| Arm | Type | Receives |
|---|---|---|
| TAU+VR | Experimental | Behavioral: Cognitive Miljeu Therapy, Behavioral: Virtual Reality based CBT for Anxiety |
| TAU | Active comparator | Behavioral: Cognitive Miljeu Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (+18 years) admitted to the standard dual diagnosis treatment program in the Mental Health Services of the Capital Region of Denmark.
- Fulfilling diagnostic criteria for a F20-29 disorder and dependence syndrome of either alcohol or drugs in the ICD-10 diagnostic manual.
- Scoring 6 or above on the avoidance subscale and 66 or above on the distress subscale scale of the O-AS. This corresponds to severe levels of avoidance and distress36.
Key exclusion criteria (2 listed)
- Incapable of providing informed consent.
- Insufficient knowledge of the Danish and/or English language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Miljeu TherapyTAU 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. | Behavioural | TAU, TAU+VR |
| Virtual Reality based CBT for AnxietyThe 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. | Behavioural | TAU+VR |
Primary outcome
Oxford Agoraphobic Avoidance Scale
Time frame: From enrollment to 3 month post treatment (16.9 weeks)
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
Client Satisfaction Questionnaire
Time frame: From enrollment to post treatment (4 to 8 weeks)
The Client Satisfaction Questionnaire is an 8-item scale loading to one factor of satisfaction with mental healthcare service.
Systems Useability Scale
Time frame: From enrollment to post treatment (4 to 8 weeks)
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.
4 secondary outcomes
Timeline Followback
Time frame: From enrollment to 3 month post treatment (16.9 weeks)
The Six-item Positive and Negative Symptom Syndrome Scale
Time frame: From enrollment to 3 month post treatment (16.9 weeks)
The Social Functioning Scale
Time frame: From enrollment to 3 month post treatment (16.9 weeks)
The Questionnaire about the Process of Recovery
Time frame: From enrollment to 3 month post treatment (16.9 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Arnfred, phd principal investigator
Mental Health Centre St. Hans
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Miljeu Therapy and Virtual Reality based CBT for Anxiety in people with Dual Diagnosis and Psychosis, run by Mental Health Centre Sct. Hans.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Arnfred, phd (31724603 ext. +45, barn0006@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Agoraphobic Avoidance Scale (time frame: From enrollment to 3 month post treatment (16.9 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.