Using virtual reality to improve cognitive function in patients with mood and psychotic disorders
Effect of Immersive Virtual Reality-based Cognitive Remediation in Patients With Mood Disorders or Psychosis Spectrum Disorders: a Randomized, Controlled, Double-blinded Trial
This study is testing if a four-week virtual reality program can help improve thinking skills in people with mood disorders and psychosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Mental Health Services in the Capital Region, Denmark Academic / other |
| Locations | 1 site (Frederiksberg, Capital Region Of Copenhagen) |
| Trial ID | NCT06038955 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a four-week immersive virtual reality (VR) cognitive remediation program on cognition and functional capacity in patients with mood disorders (like depression and bipolar disorder) and psychosis spectrum disorders (such as schizophrenia). Participants will engage in simulated daily-life challenges designed to enhance cognitive skills. The study will assess cognitive improvements using a novel VR test and traditional neuropsychological measures, with a focus on both objective and subjective cognitive impairments. The trial aims to recruit 66 participants to ensure sufficient data for analysis, accounting for potential dropouts.
Who should consider this trial
Good fit: Ideal candidates are Danish-speaking outpatients with stable mood disorders or psychosis spectrum disorders who exhibit cognitive impairments.
Not a fit: Patients who do not have cognitive impairments or are not fluent in Danish may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance cognitive function and daily living skills for patients with mood and psychotic disorders.
How similar studies have performed: While the use of virtual reality in cognitive remediation is a novel approach, preliminary studies have shown promise in similar interventions for cognitive impairments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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 * 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
Where this trial is running
Frederiksberg, Capital Region Of Copenhagen
- Neurocognition and Emotion in Affective Disorders (NEAD) Centre, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Frederiksberg hospital — Frederiksberg, Capital Region Of Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Kamilla Woznica Miskowiak, DMSc, DPhil — Mental Health Services in the Capital Region, Denmark
- Study coordinator: Andreas Elleby Jespersen, PhD-student
- Email: andreas.elleby.jespersen@regionh.dk
- Phone: +4528587815
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.