Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06038955
Status:
RECRUITING
Last Update Posted:
2024-01-09
First Post:
2023-09-08
Brief Title:
Effect of Immersive Virtual Reality-based Cognitive Remediation in Patients With Mood - or Psychosis Spectrum Disorders
Sponsor:
Mental Health Services in the Capital Region Denmark
Organization:
Mental Health Services in the Capital Region Denmark
Study Overview
Official Title:
Effect of Immersive Virtual Reality-based Cognitive Remediation in Patients With Mood Disorders or Psychosis Spectrum Disorders a Randomized Controlled Double-blinded Trial
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
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
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 psychosis spectrum disorders F20-F29 that have been assessed to be relatively symptom stable by their treating clinician upon referral to the study To accommodate for an approximately 20 drop-out rate from baseline to treatment completion the primary outcome assessement time point the investigators will recruit up to 66 participants 33 participants per intervention arm to obtain complete data for minimum 54 participants 27 participants per arm
Recruitment will be carried out through the outpatient Copenhagen Affective Disorder Clinic the outpatient early intervention clinics for psychotic disorders OPUS other mental health centres in the Capital Region of Denmark and through advertisements on relevant websites
After inclusion the baseline assessements are scheduled and completed over two days one to five days apart On day 1 the participant is assessed with the virtual cognition test the CAVIR test and a comprehensive neuropsychological test battery Participants also complete questionnaires concerning subjective cognitive complaints quality of life and general acceptance of virtual reality technology Functional capacity is assessed using a clinician-rated interview and a performance-based assessment For participants with mood disorders mood symptoms are rated with the Hamilton Depression Rating Scale HDRS-17 and Young Mania Rating Scale YMRS For participants with psychosis spectrum disorders positive and negative symptoms are rated with the Scale for the Assessement of Positive symptoms SAPS and Brief Negative Symptom Scale BNSS respectively Finally sleep quantity and quality in the past 3 days is recorded Later the same day an fMRI scan is carried out encompassing a spatial working memory N-back task a word encoding paradigm in which participants must encode and subsequently recognize words of typical household items a resting state and a structural scan On day 2 participants daily life functional capacity is assessed with The Assessement of Motor and Process Skills AMPS by an AMPS-certified occupational therapist in a standardized test kitchen
The virtual reality cognition test neuropsychological assessments questionnaires clinical symptom ratings assessements of functional capacity including AMPS and fMRI scan are repeated within 2 weeks of treatment completion primary outcome assessement time All assessments except for the fMRI scan are repeated again 3 months after treatment completion to assess durability
Participants are randomized upon full completion of the baseline assessement with allocation being carried out using the automated randomization module in the online Research Electronic Data Capture REDcap system based on an uploaded blocked randomization list stratified by age or 35 years and diagnosis mood disorders v psychosis spectrum disorder
Recruitment will be carried out through the outpatient Copenhagen Affective Disorder Clinic the outpatient early intervention clinics for psychotic disorders OPUS other mental health centres in the Capital Region of Denmark and through advertisements on relevant websites
After inclusion the baseline assessements are scheduled and completed over two days one to five days apart On day 1 the participant is assessed with the virtual cognition test the CAVIR test and a comprehensive neuropsychological test battery Participants also complete questionnaires concerning subjective cognitive complaints quality of life and general acceptance of virtual reality technology Functional capacity is assessed using a clinician-rated interview and a performance-based assessment For participants with mood disorders mood symptoms are rated with the Hamilton Depression Rating Scale HDRS-17 and Young Mania Rating Scale YMRS For participants with psychosis spectrum disorders positive and negative symptoms are rated with the Scale for the Assessement of Positive symptoms SAPS and Brief Negative Symptom Scale BNSS respectively Finally sleep quantity and quality in the past 3 days is recorded Later the same day an fMRI scan is carried out encompassing a spatial working memory N-back task a word encoding paradigm in which participants must encode and subsequently recognize words of typical household items a resting state and a structural scan On day 2 participants daily life functional capacity is assessed with The Assessement of Motor and Process Skills AMPS by an AMPS-certified occupational therapist in a standardized test kitchen
The virtual reality cognition test neuropsychological assessments questionnaires clinical symptom ratings assessements of functional capacity including AMPS and fMRI scan are repeated within 2 weeks of treatment completion primary outcome assessement time All assessments except for the fMRI scan are repeated again 3 months after treatment completion to assess durability
Participants are randomized upon full completion of the baseline assessement with allocation being carried out using the automated randomization module in the online Research Electronic Data Capture REDcap system based on an uploaded blocked randomization list stratified by age or 35 years and diagnosis mood disorders v psychosis spectrum disorder
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P-2022-411 | OTHER | Registry ID Danish Data Protection Agency | None |