Status:
COMPLETED
Effect of Immersive Virtual Reality-based Cognitive Remediation in Patients With Mood - or Psychosis Spectrum Disorders
Lead Sponsor:
Mental Health Services in the Capital Region, Denmark
Collaborating Sponsors:
TrygFonden, Denmark
University of Copenhagen
Conditions:
Bipolar Disorder
Depression
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief 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 ...
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 psyc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2024
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06038955
Start Date
October 1 2022
End Date
December 13 2024
Last Update
November 21 2025
Active Locations (1)
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1
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, 2000