Virtual Individual Cognitive Stimulation Therapy: a Proof of Concept Study
V-iCST
Virtual CST - A Collaborative Proof of Concept Study With FaceCog HK in Response to the Covid-19 Pandemic
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2021
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedFirst Posted
Study publicly available on registry
April 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedMarch 25, 2022
March 1, 2022
2 years
March 23, 2021
March 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Recruitment (feasibility of V-iCST)
Feasibility of recruitment by successful recruitment of the target sample of 32 in a 24-month period.
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.
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.
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
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.
Descriptive data will be collected during the study and analyzed post-intervention; through study completion, 2 years
Secondary Outcomes (6)
Change in cognitive function
Pre-test (baseline: week 0) and post test (week 9)
Change in cognitive function
Pre-test (baseline: week 0) and post test (week 9)
Change in quality of life
Pre-test (baseline: week 0) and post test (week 9)
Change in mood
Pre-test (baseline: week 0) and post test (week 9)
Change in communication
Pre-test (baseline: week 0) and post test (week 9)
- +1 more secondary outcomes
Study Arms (2)
Virtual Individual Cognitive Stimulation Therapy
EXPERIMENTALVirtual 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.
Treatment as usual
NO INTERVENTIONStandard care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of dementia, according to the DSM-IV
- MoCA - BLIND ≥ 2
- Age ≥ 18
- Ability to communicate in English
- Ability to complete outcome measures
- Capacity to consent
- Consent to video-conferencing
- Access to video-conferencing
You may not qualify if:
- \) Illness and disability that affects participation (as deemed by researcher)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College, Londonlead
- The University of Hong Kongcollaborator
Study Sites (1)
UCL
London, WC1E 6BT, United Kingdom
Related Publications (6)
Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.
PMID: 12021425BACKGROUNDRosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.
PMID: 6496779BACKGROUNDKinney JM, Rentz CA. Observed well-being among individuals with dementia: Memories in the Making, an art program, versus other structured activity. Am J Alzheimers Dis Other Demen. 2005 Jul-Aug;20(4):220-7. doi: 10.1177/153331750502000406.
PMID: 16136845BACKGROUNDHolden UP, Woods RT. Positive approaches to dementia care. Edinburgh: Churchill Livingstone, 1995.
BACKGROUNDYesavage JA, Sheikh JI. Geriatric Depression Scale (GDS) Recent evidence and development of shorter version. Clin Gerontol. 1986;5(1-2):165-73.
BACKGROUNDWittich W, Phillips N, Nasreddine ZS, Chertkow H. Sensitivity and Specificity of the Montreal Cognitive Assessment Modified for Individuals who are Visually Impaired. Journal of Visual Impairment & Blindness. 2010;104(6):360-368.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aimee Spector, PhD, DClinPsy
UCL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Single-blind. The assessor will be blinded. Due to the nature of the intervention, the facilitator, and participants cannot be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2021
First Posted
April 2, 2021
Study Start
April 1, 2021
Primary Completion
April 1, 2023
Study Completion
September 1, 2025
Last Updated
March 25, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Upon study completion.
- Access Criteria
- Email authors.
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.