Virtual Individual Cognitive Stimulation Therapy: a Proof of Concept Study (V-iCST)

University College London (UCL)

Status: Active, not recruiting

Conditions: Dementia of Alzheimer Type; Dementia, Mild; Dementia Frontotemporal; Dementia, Vascular; Dementia Frontal; Dementia With Lewy Bodies; Dementia Alzheimers; Dementia Moderate; Dementia; Dementia, Multi-Infarct; Dementia, Mixed

Treatments: Other: Virtual Individual Cognitive Simulation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04828434

17127/002/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of dementia, according to the DSM-IV
2. MoCA - BLIND ≥ 2
3. Age ≥ 18
4. Ability to communicate in English
5. Ability to complete outcome measures
6. Capacity to consent
7. Consent to video-conferencing
8. Access to video-conferencing

Exclusion criteria

1. Illness and disability that affects participation (as deemed by researcher)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Virtual Individual Cognitive Stimulation Therapy

Experimental group

Description:

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.

Treatment:

Other: Virtual Individual Cognitive Simulation Therapy

Treatment as usual

No Intervention group

Description:

Standard care.