NCT06038955

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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2024

Completed
Last Updated

November 21, 2025

Status Verified

January 1, 2024

Enrollment Period

2.2 years

First QC Date

September 8, 2023

Last Update Submit

November 18, 2025

Conditions

Bipolar DisorderDepressionPsychotic DisordersCognitive ImpairmentSchizophreniaSchizotypal Disorder

Keywords

CognitionCognitive ImpairmentCognitive RemediationDepressionBipolar DisorderSchizophreniaSchizotypal DisorderPsychotic DisordersVirtual Reality

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Baseline, treatment completion and 3-months follow-up

  • Assessement of Motor and Process skills (AMPS)

    Baseline, treatment completion and 3-months follow-up

Other Outcomes (16)

  • One Touch Stocking of Cambridge

    Baseline, treatment completion and 3-months follow-up

  • Spatial Working Memory test

    Baseline, treatment completion and 3-months follow-up

  • Rapid Visual Information Processing

    Baseline, treatment completion and 3-months follow-up

  • +13 more other outcomes

Study Arms (2)

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.

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.

Behavioral: Virtual reality control training

Interventions

Virtual reality Based Cognitive RemediationBEHAVIORAL

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 Based Cognitive Remediation
Virtual reality control trainingBEHAVIORAL

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.

Virtual reality control treatment

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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, 2000, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 34923359BACKGROUND

  • Jespersen 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.

    PMID: 38268043DERIVED

MeSH Terms

Conditions

Bipolar DisorderDepressionPsychotic DisordersCognitive DysfunctionSchizophreniaSchizotypal Personality Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersBehavioral SymptomsBehaviorSchizophrenia Spectrum and Other Psychotic DisordersCognition DisordersNeurocognitive DisordersPersonality Disorders

Study Officials

  • Kamilla Woznica Miskowiak, DMSc, DPhil

    Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The study has a double-blinded design. Neither the participant nor the outcome-assessors will know whether the participant is receiving VR-based cognitive remediation or VR control treatment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, controlled, double-blinded, parallel-group design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 15, 2023

Study Start

October 1, 2022

Primary Completion

November 27, 2024

Study Completion

December 13, 2024

Last Updated

November 21, 2025

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)