An interventional study of Virtual Individual Cognitive Simulation Therapy in Dementia, Dementia, Vascular and Dementia, Mixed, sponsored by University College, London. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-25.
Sponsored by University College, London · Not applicable, Interventional, and Treatment
Among 20 studies in Dementia by University College, London — 4 open to participants now, 6 under way, 1 of them phase 3. Dementia · University College, London.
Among the 20 studies in Dementia by University College, London, this one is the 9th largest by enrollment of the 13 interventional ones, is one of 3 that started in 2021, is one of 10 with no phase, and was the 14th registered.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's enrollment of 34 is below the median of 90 across 1,758 interventional studies indexed under Dementia.
Browse Dementia studies →4 of the 20 studies in Dementia by University College, London are open now, in 2 countries. Each count lists the studies.
Of the 381 Dementia studies recruiting now, 242 (64%) set no upper age limit and 25 (7%) stop at 75 or younger; 16 take children under 18; 163 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →20 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 3 started in 2021.
Median enrollment 48 across the 13 interventional studies, 220 across the 7 observational. Of the 6 that completed or were terminated, 2 (33%) have results posted.
University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 20 studies in Dementia by University College, London, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Virtual Cognitive Stimulation Therapy (V-iCST), a psychosocial intervention, is a modified version of CST for people with mild to moderate dementia. Like the original CST, each of the 14 sessions will begin with a "warm-up activity," which includes an orientation task and discussion of current affairs, followed by a main activity. V-iCST will be prescribed to participants twice a week, for 7 weeks and each session is approx. 45 minutes. The intervention will be delivered by trained professionals, such as research staff, psychologists, and trainee clinical psychologists. All facilitators will have experience in dementia care and will have completed the CST training.
Other: Virtual Individual Cognitive Simulation Therapy
Standard care.
Virtual Individual Cognitive Stimulation Therapy (V-iCST) is an individual and virtual adaptation of Cognitive Stimulation Therapy (CST), a routine psychosocial treatment for people with mild to moderate dementia in the UK.
Recruitment (feasibility of V-iCST)
Feasibility of recruitment by successful recruitment of the target sample of 32 in a 24-month period.
Time frame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Retention rate (feasibility of V-iCST)
Retention rate of at least 75% of participants at 9-week follow-up.
Time frame: Descriptive data will be collected during the study and analyzed post-intervention; at 9-week follow-up
Attendance and retention rate (acceptability of V-iCST)
Overall attendance and retention rates among the participants (60%) at 9-week follow-up.
Time frame: Descriptive data will be collected during the study and analyzed post-intervention; at 9-week follow-up
Negative of adverse events (acceptability of V-iCST)
Any negative or adverse events related to the intervention
Time frame: Descriptive data will be collected during the study and analyzed post-intervention; through study completion, 2 years
Fidelity (acceptability of V-iCST)
Fidelity will also be assessed to ensure that facilitators adhered to the protocol. Fidelity will be evaluated by a) facilitators' completion of the fidelity checklist following each session; b) vide recordings of all sessions and an independent researcher rating fidelity with a random 10% of the recordings.
Time frame: Descriptive data will be collected during the study and analyzed post-intervention; through study completion, 2 years
Change in cognitive function
Exploratory outcome; measured pre-and post-intervention with Montreal Cognitive Assessment Blind Version (MoCA-BLIND) (Wittich et al., 2010). MoCA - BLIND is a short version of the Montreal Cognitive Assessment designed for the visually impaired. It consists of 6 items with scores from 0 to 22, where a low score indicates poor performance.
Time frame: Pre-test (baseline: week 0) and post test (week 9)
Change in cognitive function
Exploratory outcome; measured pre-and post-intervention with Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) (Rosen et al., 1984). ADAS-Cog is a sensitive scale measuring cognitive function with more items on short-term memory. This scale is frequently used in dementia drug trials, and has 11 items, and a total score of 70, where the higher the score, the more severe the impairments.
Time frame: Pre-test (baseline: week 0) and post test (week 9)
Change in quality of life
Exploratory outcome; measured pre-and post-test with Quality of Life in Alzheimer's Disease (QoL-AD) (Logsdon et al., 2002). QoL-AD has 13-items, and a sum score range from 13 to 52; higher score denotes better quality of life.
Time frame: Pre-test (baseline: week 0) and post test (week 9)
Change in mood
Exploratory outcome; measured pre-and post-test with Geriatric Depression Scale (GDS), a dichotomous screening tool with 15 items. Participants answer "yes" or "no" to symptoms of depression. A score of 10 or higher indicates depression.
Time frame: Pre-test (baseline: week 0) and post test (week 9)
Change in communication
Exploratory outcome; measured pre-and post-test with Holden Communication Scale (Strom et al., 2016), a proxy-based instrument with 12 items developed to evaluate conversation, awareness, knowledge and communication. Each item contains five response options on a scale of 0 to 4, with a maximum score of 48. A higher score suggests difficulties with communication.
Time frame: Pre-test (baseline: week 0) and post test (week 9)
Change in engagement
Exploratory outcome; measured with the Adapted Greater Cincinnati Chapter Well-Being Observation Tool (Adapted GCCWBOT) (Kinney \& Rentz, 2005). An independent researcher will assess session recordings of every participant. Each evaluation will be 62 minutes, and 8 domains will be assessed: interest, attention, pleasure, self-esteem, normalcy, disengagement, sadness, and negative affect.
Time frame: Evaluated by an independent researcher through video recordings; up to 48 months.
Plan to share: Yes — Study results will be published in peer-reviewed journals, doctoral theses and presented at conferences, and disseminated to the public through information sheets. Participants who indicate their interest in receiving further information regarding dissemination will be sent a letter with the main findings of the study upon completion.
Time frame: Upon study completion.
Access criteria: Email authors.
Started Apr 2021 (actual). Primary completion is estimated for Apr 2023, 24 months after the start.
Of 855 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 24 months is close to that.
Counting every sponsor, half of 901 studies reached it within 25 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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