Bipolar DisorderNCT06038955
Effect of Immersive Virtual Reality-based Cognitive Remediation in Patients With Mood - or Psychosis Spectrum Disorders
A study testing Virtual reality Based Cognitive Remediation in people with Bipolar Disorder and Depression, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to investigate the effect of a four-weeks, intensive virtual reality (VR)-based cognitive remediation (training) programme involving simulated daily-life challenges on cognition and functional capacity in symptomatically stable patients with mood disorders (depression or bipolar… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bipolar Disorder, Depression, Psychotic Disorders
- What is being tested?
- Virtual reality Based Cognitive Remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2022to 13 Dec 2024
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fluent Danish skills
- Meet the International Classification of Diseases 10th edition (ICD-10) diagnosis of unipolar disorder, bipolar disorder (types I and II) or a psychosis spectrum disorder (i.e. F20-F29) confirmed using the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) interview
- Patients must have objective and subjective cognitive impairment at the time of inclusion. Objective cognitive impairment is defined a total score on the Screen for Cognitive Impairment in Psychiatry - Danish version (SCIP-D) ≥ 0.5 standard deviations (SD) below the expected total score based on age, education, and gender or as a score ≥ 0.5 SD below the expected score on a minimum of two out of the five subtests (verbal learning test - immediate, working memory test, verbal fluency test, verbal learning, test - delayed, and processing speed test). Subjective cognitive impairment is defined as a score ≥ 14 on the Cognitive Complaints in Bipolar Disorder Rating Scale (COBRA).
Who cannot join
- Current drug or substance abuse
- A daily use of benzodiazepines >22.5 mg oxazepam or >7.5 mg diazepam (cutoffs for doses with limited cognitive side effects)
- Comorbid neurological disorder
- Previous serious head trauma
- Dyslexia
- Pregnancy
Show all 9Show fewer
- Claustrophobia (fMRI scan)
- Having a pacemaker or other metal implants inside the body (fMRI scan)
- Having had electroconvulsive therapy in the 3 months prior to inclusion
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Neurocognition and Emotion in Affective Disorders (NEAD) Centre, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Frederiksberg hospital
Frederiksberg, Capital Region of Copenhagen, 2000
About this study
Official title: Effect of Immersive Virtual Reality-based Cognitive Remediation in Patients With Mood Disorders or Psychosis Spectrum Disorders: a Randomized, Controlled, Double-blinded Trial
The goal of this clinical trial is to investigate the effect of a four-weeks, intensive virtual reality (VR)-based cognitive remediation (training) programme involving simulated daily-life challenges on cognition and functional capacity in symptomatically stable patients with mood disorders (depression or bipolar disorder) or psychosis spectrum disorders (F20-F29; e.g. schizophrenia or schizotypal disorder).
The investigators hypothesize that VR-based cognitive remediation vs. a VR control treatment has a beneficial effect on cognition after four-weeks treatment completion (primary outcome assessement time) measured with a novel ecologically valid VR test of daily-life cognitive functions (The CAVIR test; primary outcome measure), a verbal learning and memory composite score based on a traditional neuropsychological test and a performance-based measure of daily functioning (secondary outcome measures). Finally, for exploratory purposes, the study will examine neuronal underpinnings of treatment effects, and effects on additional measures of cognition, functioning and self-ratings scales (tertiary outcomes).
Read the detailed description
The current study will include outpatients with a mood disorders (unipolar - or bipolar disorder) in full or partial remission at the time of inclusion (score ≤ 14 on the Hamilton Depression or a psychosis spectrum disorders (F20-F29) that have been assessed to be relatively symptom stable by their treating clinician upon referral to the study. To accommodate for an approximately 20% drop-out rate from baseline to treatment completion (the primary outcome assessement time point), the investigators will recruit up to 66 participants (33 participants per intervention arm) to obtain complete data for minimum 54 participants (27 participants per arm).
Recruitment will be carried out through the outpatient Copenhagen Affective Disorder Clinic, the outpatient, early intervention clinics for psychotic disorders (OPUS), other mental health centres in the Capital Region of Denmark, and through advertisements on relevant websites.
After inclusion, the baseline assessements are scheduled and completed over two days, one to five days apart. On day 1, the participant is assessed with the virtual cognition test (the CAVIR test) and a comprehensive neuropsychological test battery. Participants also complete questionnaires concerning subjective cognitive complaints, quality of life and general acceptance of virtual reality technology. Functional capacity is assessed using a clinician-rated interview and a performance-based assessment. For participants with mood disorders, mood symptoms are rated with the Hamilton Depression Rating Scale (HDRS-17) and Young Mania Rating Scale (YMRS). For participants with psychosis spectrum disorders, positive and negative symptoms are rated with the Scale for the Assessement of Positive symptoms (SAPS) and Brief Negative Symptom Scale (BNSS), respectively. Finally, sleep quantity and quality in the past 3 days is recorded. Later the same day an fMRI scan is carried out encompassing a spatial working memory N-back task, a word encoding paradigm in which participants must encode and subsequently recognize words of typical household items, a resting state, and a structural scan. On day 2, participants' daily life functional capacity is assessed with The Assessement of Motor and Process Skills (AMPS) by an AMPS-certified occupational therapist in a standardized test kitchen.
The virtual reality cognition test, neuropsychological assessments, questionnaires, clinical symptom ratings, assessements of functional capacity (including AMPS) and fMRI scan are repeated within 2 weeks of treatment completion (primary outcome assessement time). All assessments except for the fMRI scan are repeated again 3 months after treatment completion to assess durability.
Participants are randomized upon full completion of the baseline assessement with allocation being carried out using the automated randomization module in the online Research Electronic Data Capture (REDcap) system based on an uploaded blocked randomization list stratified by age (< or ≥ 35 years) and diagnosis (mood disorders v. psychosis spectrum disorder)
- Conditions
- Bipolar Disorder, Depression, Psychotic Disorders, Cognitive Impairment, Schizophrenia, Schizotypal Disorder
- Being tested
- Virtual reality Based Cognitive Remediation, Virtual reality control training
- Keywords
- Cognition, Cognitive Impairment, Cognitive Remediation, Depression, Bipolar Disorder, Schizophrenia, Schizotypal Disorder, Psychotic Disorders, Virtual Reality
- Medical subject headings
- Bipolar Disorder, Depression, Psychotic Disorders, Cognitive Dysfunction, Schizophrenia, Schizotypal Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality Based Cognitive RemediationBehavioural
The main component of the intervention is a virtual reality training platform in 360° Oculus Quest 2-software in which participants train their cognitive abilities guided by the therapist. The platform includes four immersive daily-life scenarios in which patients have consistently reported that they often experience cognitive difficulties: (1) a kitchen scenario focusing on planning and cooking a meal, (2) a supermarket scenario focusing on grocery shopping, (3) a restaurant scenario focusing on remembering names and personal information and (4) an office scenario focusing on planning, initiating, and completing work assignments. The virtual reality training is supported by a psychoeducation program that focuses on application of learned cognitive strategies in daily life.
Virtual reality control trainingBehavioural
The virtual reality control training involves completing different virtual reality games that are available through the Oculus Quest games store.The chosen games involve no direct training of cognitive abilities such as planning skills og strategic learning, but merely involves simple reaction time and interaction with an entertaining environment that is meaningful to the participant and gives the impression of training cognitive skills.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality Based Cognitive Remediation | Experimental | The cognitive remediation program has a duration of four weeks and involves two weekly 1,5-hour virtual reality-based cognitive training sessions with a therapist accompanied by additional between-session virtual reality training at home and homework assignments consisting of cognitively challenging daily life tasks. Receives: Behavioral: Virtual reality Based Cognitive Remediation |
| Virtual reality control treatment | Sham comparator | The control treatment program also has a duration of four weeks and involves one weekly 2-hour session with a therapist. Receives: Behavioral: Virtual reality control training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition Assessement in Virtual Reality (CAVIR) test: cognitive composite score
The primary outcome measure is a broad cognitive composite score spanning all five subtasks on a novel virtual reality test of daily-life cognitive functions, the Cognition Assessement in Virtual Reality (CAVIR) test. The CAVIR test is a self-administered 360º immersive VR test in a kitchen, where the participant's abilities to plan and prepare a meal are assessed. The test has a duration of 15 minutes and involves five subtasks probing verbal memory, executive functions, processing speed, working memory and sustained attention, respectively. The cognitive composite score is calculated by averaging the z-transformed scores on the five CAVIR subtasks. No score range. Higher scores mean a better outcome.
Measured: Baseline, treatment completion (primary outcome assessement time point) and 3-months follow-up
Secondary outcomes (2)
Rey Auditory Verbal Learning Test (RAVLT): verbal learning and memory domain composite score
A domain composite of 'verbal learning and memory' comprising the following subtests on the Rays Verbal Learning (RAVLT) Test: RAVLT total recall lists I-V, RAVLT immediate recall, RAVLT delayed recall. Score range 0-120. Higher scores mean a better outcome
Measured: Baseline, treatment completion and 3-months follow-up
Assessement of Motor and Process skills (AMPS)
A recommended measure of functioning (i.e. Activity of Daily Living) in individuals with psychiatric illness and cognitive impairment conducted by an AMPS-certificated occupational therapist a standardized test apartment. During an AMPS-evaluation, two domains of performance are evaluated: ADL motor skills (16 items) and ADL process skills (20 items). Scoring of the AMPS assessment is conducted using t available software Occupational Therapy Assessment Package (OTAP) reporting software. OTAP is based on a many-faceted Rasch measurement model making it possible to convert ordinal raw scores into overall linear ADL motor and process ability measures adjusted for severity of the task, skill item difficulty, and rater severity (determined based on rater calibration). A clinically relevant difference has been determined as ≥0.3 logit on the ADL motor or process ability scales. Higher scores mean a better outcome.
Measured: Baseline, treatment completion and 3-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Oct 2022
- Primary completion27 Nov 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies 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
- Randomized, controlled, double-blinded, parallel-group design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark, University of Copenhagen, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Kamilla Woznica Miskowiak, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Investigators
- Kamilla Woznica Miskowiak, DMSc, DPhil, Principal investigator, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038955
- Sponsor's protocol ID
- H-22004153
- Other IDs
- P-2022-411
- Status last verified
- Jan 2024
- First submitted
- 8 Sep 2023
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miskowiak KW, Jespersen AE, Kessing LV, Aggestrup AS, Glenthoj LB, Nordentoft M, Ott CV, Lumbye A. Cognition Assessment in Virtual Reality: Validity and feasibility of a novel virtual reality test for real-life cognitive functions in mood disorders and psychosis spectrum disorders. J Psychiatr Res. 2022 Jan;145:182-189. doi: 10.1016/j.jpsychires.2021.12.002. Epub 2021 Dec 12.
PubMed 34923359Jespersen AE, Lumbye A, Vinberg M, Glenthoj LB, Nordentoft M, Bruun CF, von Bulow C, Makransky G, Waehrens EE, Miskowiak KW. Virtual reality-based cognitive remediation versus virtual reality control in people with mood or psychosis spectrum disorders in Denmark: a single-centre, double-blind, randomised controlled trial. Lancet Digit Health. 2026 Jun;8(6):101002. doi: 10.1016/j.landig.2026.101002. Epub 2026 May 8.
PubMed 42106222Jespersen AE, Lumbye A, Vinberg M, Glenthoj L, Nordentoft M, Waehrens EE, Knudsen GM, Makransky G, Miskowiak KW. Effect of immersive virtual reality-based cognitive remediation in patients with mood or psychosis spectrum disorders: study protocol for a randomized, controlled, double-blinded trial. Trials. 2024 Jan 24;25(1):82. doi: 10.1186/s13063-024-07910-7.
PubMed 38268043
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immersive Virtual Reality-based Cognitive Remediation in Patients With Mood Disorders or Psychosis Spectrum Disorders: a Randomized, Controlled, Double-blinded Trial
- ClinicalTrials.gov ID
- NCT06038955
- Acronym / sponsor ID
- H-22004153
- Conditions
- Bipolar Disorder, Depression, Psychotic Disorders, Cognitive Impairment, Schizophrenia, Schizotypal Disorder
- Keywords
- Cognition, Cognitive Impairment, Cognitive Remediation, Depression, Bipolar Disorder, Schizophrenia, Schizotypal Disorder, Psychotic Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark, University of Copenhagen, Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 15 Sep 2023 (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.
The goal of this clinical trial is to investigate the effect of a four-weeks, intensive virtual reality (VR)-based cognitive remediation (training) programme involving simulated daily-life challenges on cognition and functional capacity in symptomatically stable patients with mood disorders (depression or bipolar disorder) or psychosis spectrum disorders (F20-F29; e.g. schizophrenia or schizotypal disorder).
The investigators hypothesize that VR-based cognitive remediation vs. a VR control treatment has a beneficial effect on cognition after four-weeks treatment completion (primary outcome assessement time) measured with a novel ecologically valid VR test of daily-life cognitive functions (The CAVIR test; primary outcome measure), a verbal learning and memory composite score based on a traditional neuropsychological test and a performance-based measure of daily functioning (secondary outcome measures). Finally, for exploratory purposes, the study will examine neuronal underpinnings of treatment effects, and effects on additional measures of cognition, functioning and self-ratings scales (tertiary outcomes).
Detailed description
The current study will include outpatients with a mood disorders (unipolar - or bipolar disorder) in full or partial remission at the time of inclusion (score ≤ 14 on the Hamilton Depression or a psychosis spectrum disorders (F20-F29) that have been assessed to be relatively symptom stable by their treating clinician upon referral to the study. To accommodate for an approximately 20% drop-out rate from baseline to treatment completion (the primary outcome assessement time point), the investigators will recruit up to 66 participants (33 participants per intervention arm) to obtain complete data for minimum 54 participants (27 participants per arm).
Recruitment will be carried out through the outpatient Copenhagen Affective Disorder Clinic, the outpatient, early intervention clinics for psychotic disorders (OPUS), other mental health centres in the Capital Region of Denmark, and through advertisements on relevant websites.
After inclusion, the baseline assessements are scheduled and completed over two days, one to five days apart. On day 1, the participant is assessed with the virtual cognition test (the CAVIR test) and a comprehensive neuropsychological test battery. Participants also complete questionnaires concerning subjective cognitive complaints, quality of life and general acceptance of virtual reality technology. Functional capacity is assessed using a clinician-rated interview and a performance-based assessment. For participants with mood disorders, mood symptoms are rated with the Hamilton Depression Rating Scale (HDRS-17) and Young Mania Rating Scale (YMRS). For participants with psychosis spectrum disorders, positive and negative symptoms are rated with the Scale for the Assessement of Positive symptoms (SAPS) and Brief Negative Symptom Scale (BNSS), respectively. Finally, sleep quantity and quality in the past 3 days is recorded. Later the same day an fMRI scan is carried out encompassing a spatial working memory N-back task, a word encoding paradigm in which participants must encode and subsequently recognize words of typical household items, a resting state, and a structural scan. On day 2, participants' daily life functional capacity is assessed with The Assessement of Motor and Process Skills (AMPS) by an AMPS-certified occupational therapist in a standardized test kitchen.
The virtual reality cognition test, neuropsychological assessments, questionnaires, clinical symptom ratings, assessements of functional capacity (including AMPS) and fMRI scan are repeated within 2 weeks of treatment completion (primary outcome assessement time). All assessments except for the fMRI scan are repeated again 3 months after treatment completion to assess durability.
Participants are randomized upon full completion of the baseline assessement with allocation being carried out using the automated randomization module in the online Research Electronic Data Capture (REDcap) system based on an uploaded blocked randomization list stratified by age (< or ≥ 35 years) and diagnosis (mood disorders v. psychosis spectrum disorder)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, double-blinded, parallel-group design
| Arm | Type | Receives |
|---|---|---|
| Virtual reality Based Cognitive Remediation | Experimental | Behavioral: Virtual reality Based Cognitive RemediationThe cognitive remediation program has a duration of four weeks and involves two weekly 1,5-hour virtual reality-based cognitive training sessions with a therapist accompanied by additional between-session virtual reality training at home and homework assignments consisting of cognitively challenging daily life tasks. |
| Virtual reality control treatment | Sham comparator | Behavioral: Virtual reality control trainingThe control treatment program also has a duration of four weeks and involves one weekly 2-hour session with a therapist. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fluent Danish skills
- Meet the International Classification of Diseases 10th edition (ICD-10) diagnosis of unipolar disorder, bipolar disorder (types I and II) or a psychosis spectrum disorder (i.e. F20-F29) confirmed using the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) interview
- Patients must have objective and subjective cognitive impairment at the time of inclusion. Objective cognitive impairment is defined a total score on the Screen for Cognitive Impairment in Psychiatry - Danish version (SCIP-D) ≥ 0.5 standard deviations (SD) below the expected total score based on age, education, and gender or as a score ≥ 0.5 SD below the expected score on a minimum of two out of the five subtests (verbal learning test - immediate, working memory test, verbal fluency test, verbal learning, test - delayed, and processing speed test). Subjective cognitive impairment is defined as a score ≥ 14 on the Cognitive Complaints in Bipolar Disorder Rating Scale (COBRA).
Key exclusion criteria (9 listed)
- Current drug or substance abuse
- A daily use of benzodiazepines >22.5 mg oxazepam or >7.5 mg diazepam (cutoffs for doses with limited cognitive side effects)
- Comorbid neurological disorder
- Previous serious head trauma
- Dyslexia
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 |
|---|---|---|
| Virtual reality Based Cognitive RemediationThe main component of the intervention is a virtual reality training platform in 360° Oculus Quest 2-software in which participants train their cognitive abilities guided by the therapist. The platform includes four immersive daily-life scenarios in which patients have consistently reported that they often experience cognitive difficulties: (1) a kitchen scenario focusing on planning and cooking a meal, (2) a supermarket scenario focusing on grocery shopping, (3) a restaurant scenario focusing on remembering names and personal information and (4) an office scenario focusing on planning, initiating, and completing work assignments. The virtual reality training is supported by a psychoeducation program that focuses on application of learned cognitive strategies in daily life. | Behavioural | Virtual reality Based Cognitive Remediation |
| Virtual reality control trainingThe virtual reality control training involves completing different virtual reality games that are available through the Oculus Quest games store.The chosen games involve no direct training of cognitive abilities such as planning skills og strategic learning, but merely involves simple reaction time and interaction with an entertaining environment that is meaningful to the participant and gives the impression of training cognitive skills. | Behavioural | Virtual reality control treatment |
Primary outcome
Cognition Assessement in Virtual Reality (CAVIR) test: cognitive composite score
Time frame: Baseline, treatment completion (primary outcome assessement time point) and 3-months follow-up
The primary outcome measure is a broad cognitive composite score spanning all five subtasks on a novel virtual reality test of daily-life cognitive functions, the Cognition Assessement in Virtual Reality (CAVIR) test. The CAVIR test is a self-administered 360º immersive VR test in a kitchen, where the participant's abilities to plan and prepare a meal are assessed. The test has a duration of 15 minutes and involves five subtasks probing verbal memory, executive functions, processing speed, working memory and sustained attention, respectively. The cognitive composite score is calculated by averaging the z-transformed scores on the five CAVIR subtasks. No score range. Higher scores mean a better outcome.
2 secondary outcomes
Rey Auditory Verbal Learning Test (RAVLT): verbal learning and memory domain composite score
Time frame: Baseline, treatment completion and 3-months follow-up
Assessement of Motor and Process skills (AMPS)
Time frame: Baseline, treatment completion and 3-months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Background: PubMed 34923359Miskowiak KW, Jespersen AE, Kessing LV, Aggestrup AS, Glenthoj LB, Nordentoft M, Ott CV, Lumbye A. Cognition Assessment in Virtual Reality: Validity and feasibility of a novel virtual reality test for real-life cognitive functions in mood disorders and psychosis spectrum disorders. J Psychiatr Res. 2022 Jan;145:182-189. doi: 10.1016/j.jpsychires.2021.12.002. Epub 2021 Dec 12.
- Derived from this study: PubMed 42106222Jespersen AE, Lumbye A, Vinberg M, Glenthoj LB, Nordentoft M, Bruun CF, von Bulow C, Makransky G, Waehrens EE, Miskowiak KW. Virtual reality-based cognitive remediation versus virtual reality control in people with mood or psychosis spectrum disorders in Denmark: a single-centre, double-blind, randomised controlled trial. Lancet Digit Health. 2026 Jun;8(6):101002. doi: 10.1016/j.landig.2026.101002. Epub 2026 May 8.
- Derived from this study: PubMed 38268043Jespersen AE, Lumbye A, Vinberg M, Glenthoj L, Nordentoft M, Waehrens EE, Knudsen GM, Makransky G, Miskowiak KW. Effect of immersive virtual reality-based cognitive remediation in patients with mood or psychosis spectrum disorders: study protocol for a randomized, controlled, double-blinded trial. Trials. 2024 Jan 24;25(1):82. doi: 10.1186/s13063-024-07910-7.
- Individual participant dataSharing planned: No
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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.
Kamilla Woznica Miskowiak, DMSc, DPhil principal investigator
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality Based Cognitive Remediation in people with Bipolar Disorder and Depression, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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 9 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: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition Assessement in Virtual Reality (CAVIR) test: cognitive composite score (time frame: Baseline, treatment completion (primary outcome assessement time point) and 3-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06038955, which also lists 3 linked publications.
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 21 Nov 2025.