Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:54 PM
Study NCT ID:
NCT04828434
Status:
UNKNOWN
Last Update Posted:
2022-03-25
First Post:
2021-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Individual Cognitive Stimulation Therapy: a Proof of Concept Study
Sponsor:
University College, London
Organization:
Study Overview
Official Title:
Virtual CST - A Collaborative Proof of Concept Study With FaceCog HK in Response to the Covid-19 Pandemic
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
V-iCST
Brief Summary:
Due to COVID-19, the routine treatment for dementia, Cognitive Stimulation Therapy (CST), is currently suspended in multiple countries. Access to treatment is, therefore, paramount. The investigators seek to bridge the current treatment gap with a virtual and individual form of CST, called Virtual Individual Cognitive Stimulation Therapy (V-iCST). This psychosocial intervention was adapted from the key principles of CST and developed within the Medical Research Council (MRC) framework for complex interventions. The investigators aim to evaluate the feasibility and acceptability of V-iCST in a Randomized Controlled Trial.
This is a feasibility randomized controlled trial (RCT) for Virtual Individual Cognitive Stimulation Therapy (V-iCST), an evidence-based teletherapy for people with mild to moderate dementia. This psychosocial intervention is adapted from a routine and established dementia treatment, Cognitive Stimulation Therapy, and developed within the Medical Research Council (MRC) framework for complex interventions.
This is a feasibility randomized controlled trial (RCT) for Virtual Individual Cognitive Stimulation Therapy (V-iCST), an evidence-based teletherapy for people with mild to moderate dementia. This psychosocial intervention is adapted from a routine and established dementia treatment, Cognitive Stimulation Therapy, and developed within the Medical Research Council (MRC) framework for complex interventions.
Detailed Description:
Dementia, a global epidemic, affects 50 million individuals worldwide. Cognitive Stimulation Therapy (CST) is the only non-pharmacological therapy recommended by the UK government to improve cognition for mild to moderate dementia. It is delivered in over 85% of National Health Services (NHS) services and is offered in 34 countries. Unfortunately, this routine treatment is suspended due to lockdown, even though people with dementia are disproportionately affected by COVID-19. Accessible treatment is a pressing need. Virtual Individual Cognitive Stimulation Therapy (V-iCST) aims to bridge this treatment gap as an evidence-based treatment for dementia, developed within the Medical Research Council (MRC) Framework for complex interventions using principles of CST. There may still be a demand for V-iCST post-pandemic because those with sensory impairments and lack of transport provision may prefer a virtual and individual treatment. The investigators aim to 1) design V-iCST; 2) evaluate V-iCST in a feasibility Randomized Controlled Trial (RCT). A sample of 34 participants will be recruited. Seventeen will be allocated to V-iCST, and 17 to treatment as usual (TAU), the control group. Data will be collected pre-and post-test. Dementia prevalence is projected to reach 152 million worldwide by 2050. Therefore, accessible treatment is paramount during the pandemic and beyond.
Study Oversight
Has Oversight DMC:
False
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?: