NCT06038955Completed
Effect of Immersive Virtual Reality-based Cognitive Remediation in Patients With Mood - or Psychosis Spectrum Disorders
Effect of Immersive Virtual Reality-based Cognitive Remediation in Patients With Mood Disorders or Psychosis Spectrum Disorders: a Randomized, Controlled, Double-blinded Trial
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 8 Sept 2023
- Start date
- 1 Oct 2022
- Primary completion date
- 27 Nov 2024
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Diseases
- Schizophrenia, Bipolar disorder
- NCT number
- NCT06038955
What you commit to
- Study type: Interventional
- Participants enrolled: 62
- From 1 Oct 2022 to the primary completion date, 27 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current drug or substance abuse
- Previous serious head trauma
- Having a pacemaker or other metal implants inside the body (fMRI scan)
- Having had electroconvulsive therapy in the 3 months prior to inclusion
Other illness
- Comorbid neurological disorder
Other
- A daily use of benzodiazepines \>22.5 mg oxazepam or \>7.5 mg diazepam (cutoffs for doses with limited cognitive side effects)
- Dyslexia
- Pregnancy
- Claustrophobia (fMRI scan)
Who the study is looking for
- 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).
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neurocognition and Emotion in Affective Disorders (NEAD) Centre, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Frederiksberg hospital Coordinator of this site? Confirm its status | Frederiksberg | Denmark | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.