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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Dokumenter

  • Fulltext

    Forlagets udgivne version, 2,39 MB, PDF-dokument

Background
Cognitive impairments are prevalent across mood disorders and psychosis spectrum disorders, but there is a lack of real-life-like cognitive training programmes. Fully immersive virtual reality has the potential to ensure motivating and engaging cognitive training directly relevant to patients’ daily lives. We will examine the effect of a 4-week, intensive virtual reality-based cognitive remediation programme involving daily life challenges on cognition and daily life functioning in patients with mood disorders or psychosis spectrum disorders and explore the neuronal underpinnings of potential treatment efficacy.

Methods
The trial has a randomized, controlled, double-blinded, parallel-group design. We will include 66 symptomatically stable outpatients with mood disorders or psychosis spectrum disorders aged 18–55 years with objective and subjective cognitive impairment. Assessments encompassing a virtual reality test of daily life cognitive skills, neuropsychological testing, measures of daily life functioning, symptom ratings, questionnaires on subjective cognitive complaints, and quality of life are carried out at baseline, after the end of 4 weeks of treatment and at a 3-month follow-up after treatment completion. Functional magnetic resonance imaging scans are performed at baseline and at the end of treatment. The primary outcome is a broad cognitive composite score comprising five subtasks on a novel ecologically valid virtual reality test of daily life cognitive functions. Two complete data sets for 54 patients will provide a power of 80% to detect a clinically relevant between-group difference in the primary outcome. Behavioural data will be analysed using linear mixed models in SPSS, while MRI data will be analysed with the FMRIB Expert Analysis Tool (FEAT). Treatment-related changes in neural activity from baseline to end of treatment will be investigated for the dorsal prefrontal cortex and hippocampus as the regions of interest.

Discussion
The results will provide insight into whether virtual reality-based cognitive remediation has beneficial effects on cognition and functioning in symptomatically stable patients with mood disorders or psychosis spectrum disorders, which can aid future treatment development.
OriginalsprogEngelsk
Artikelnummer82
TidsskriftTrials
Vol/bind25
Udgave nummer1
Antal sider14
ISSN1745-6215
DOI
StatusUdgivet - 2024

Bibliografisk note

Funding Information:
The authors wish to thank the Copenhagen Affective Disorder Research Clinic and the early intervention clinics for psychotic disorders (OPUS) as well as other mental health centres in the Capital Region of Denmark for their assistance with the recruitment of participants. We are also grateful to focus-group participants from the School for Recovery and members of the Virtual Learning Lab, University of Copenhagen, for their valuable input during the development of the virtual reality environments. Occupational therapist and postdoc Maria Cecilie Von Bülow and occupational therapists Mie Skovmand Christensen and Thomas Buhl-Wiggers are acknowledged for their contribution in terms of completing the AMPS assessments. Finally, senior researchers Julian Macoveanu and Patrick Fisher, as well as research assistant Alexander Tobias Ysbæk-Nielsen, are acknowledged for their help in setting up the fMRI paradigms.

Funding Information:
Open access funding provided by Copenhagen University The study is supported by TrygFonden (grant no. 150128), and the study protocol has undergone external peer review as part of the funding application process. In addition, the study has received financial support from the Axel Muusfeldts Foundation (grant no. 2022-0097) and the Jascha Foundation (grant no. 2022-0134). The MR scanner was kindly donated by the KFJ Foundation. None of the funders has been involved in the study design or the writing of the current study protocol, nor will they be involved in the data collection, analysis, or interpretation of the data.

Publisher Copyright:
© 2024, The Author(s).

Antal downloads er baseret på statistik fra Google Scholar og www.ku.dk


Ingen data tilgængelig

ID: 381021436