Effect of Immersive Virtual Reality-based Cognitive Remediation in Patients With Mood - or Psychosis Spectrum Disorders

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).

Conditions

• Bipolar Disorder
• Depression
• Psychotic Disorders
• Cognitive Impairment
• Schizophrenia
• Schizotypal Disorder

Interventions

BEHAVIORAL

Virtual reality Based Cognitive Remediation

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.

BEHAVIORAL

Virtual reality control training

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.

Sponsors & Collaborators

• TrygFonden, Denmark

  collaborator INDUSTRY

• University of Copenhagen

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Mental Health Services in the Capital Region, Denmark

  lead OTHER

Principal Investigators

• Kamilla Woznica Miskowiak, DMSc, DPhil · Mental Health Services in the Capital Region, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-01

Primary Completion

2024-11-27

Completion

2024-12-13

Countries

• Denmark

Study Locations