Virtual Individual Cognitive Stimulation Therapy: a Proof of Concept Study

University College, London34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.