The aim of this clinical trial is to investigate the effects of a three-week virtual reality-based cognitive remediation training (VR-CRT) programme in combination with daily intake of a histone deacetylase inhibitor (HDACi) sodium butyrate on cognition in symptomatically stable patients with mood (depression or bipolar disorder; MD) or schizophrenia spectrum disorders.
The investigators hypothesize that the VR-based cognitive remediation training (VR-CRT) combined with HDACi butyrate vs. a VR-based control treatment combined with placebo will improve global cognition (primary outcome measure) over three weeks.
Secondly, the investigators hypothesize that VR-CRT with placebo will improve cognition relative to the VR control treatment with placebo, although to a lesser extent than VR-CRT with HDACi butyrate.
Thirdly, the investigators hypothesize that the HDACi butyrate with VR control treatment will not produce cognitive improvements relative to placebo with VR control treatment.
Finally, the investigators hypothesize that the combined treatment (VR-CRT + HDACi butyrate) will enhance neuroplasticity (exploratory outcome) vs. VR control with placebo, as indicated by increase in hippocampal volume and/or memory-related activity shown with structural and functional MRI.
Confirmed ICD-10 diagnosis of BD or recurrent UD in partial, or full remission (Hamilton Depression Rating Scale-17 items and Young Mania Rating Scale scores ≤14) or SSD assessed relatively stable by primary clinician at time of inclusion.
Subjective cognitive complaints (self-reported: COBRA ≥12) or objectively-verified cognitive impairment (measured using Screening for Cognitive Impairment in Psychiatry SCIP: total score or at least two subscores ≥ 0.5 SD below expected norms)
Fluency in Danish language
Neurological disorders (including dementia)
Dyslexia
Severe Physical illness
Kidney disease
Parallel
Virtual Reality-based cognitive remediation therapy (VR-CRT)
BehavioralVR-CRT on 360° Meta Quest 2-software in which participants train cognitive abilities guided by a therapist. The platform includes three immersive scenarios: (1) a kitchen scenario focusing on planning and cooking a meal, (2) a supermarket scenario focusing on grocery shopping and (3) a restaurant scenario focusing on remembering names and personal information. The virtual reality training is supported by a psychoeducation program that focuses on application of learned cognitive strategies in daily life.
Virtual Reality-based control treatment (VR-CT)
BehavioralVR-CT: The virtual reality control training involves completing different virtual reality games that are available through the Meta 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.
HDACi butyrate
Dietary supplementDaily intake of sodium butyrate.
Placebo
Dietary supplementDaily intake of placebo.
Cognitive composite measure
A global composite score based on the neuropsychological test across several cognitive domains: the Rey Auditory Verbal Learning Test (RAVLT)66 (verbal learning and memory), WAIS-III Letter-Number Sequencing 67 and Spatial Working Memory Test (CANTAB, SWM) (working memory), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)68 Coding (psychomotor speed), phonemic fluency and One Touch Stockings of Cambridge (CANTAB69, OTS) (executive function), RBANS Digit Span Test and Rapid Visual Information Processing (CANTAB69 , RVP), (attention) and Emotion Recognition Task (CANTAB69, emotional processing). No score range. higher scores mean a better outcome.
Verbal memory composite
A composite score of RAVLT based on three subtests: total recall, immediate recall, and delayed recall (verbal learning and memory). No score range. higher scores mean a better outcome.
Cognition Assessment in Virtual Reality (CAVIR)
The total score on our newly developed virtual reality-based daily-life real-world functioning test, Cognition Assessment in Virtual Reality (CAVIR). CAVIR includes 5 tests of verbal memory, executive functions, processing speed, working memory and attention, respectively. No score range. higher scores mean a better outcome.
Functional Assessment Short Test (FAST)
A semi-structured interview assessing level of psychosocial functioning. Score range 0-72. Higher scores mean a worse outcome.
Rey Auditory Verbal Learning Test
Neuropsychological test assessing verbal memory. Outcomes include total recall (score range 0-75), immediate recall (score range 0-15), and delayed recall (score range 0-15). Higher scores mean a better outcome.
Wechsler Adult Intelligence Scale (WAIS)-III Letter-Number Sequencing
Neuropsychological test assessing working memory. Score range 0-21. Higher scores mean a better outcome.
Spatial Working Memory Test from Cambridge Cognition (CANTAB)
Computerized neuropsychological test assessing working memory. Outcomes include errors (score range 0-153, higher scores mean a worse outcome) and strategy (score range 3-26, higher scores mean a worse outcome).
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding
Neuropsychological test assessing psychomotor speed. Score range 0-89. Higher scores mean a better outcome.
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