A clinical trial and economic assessment of Cognitive Stimulation Therapy delivered in an online modality for people living with mild to moderate dementia in Aotearoa New Zealand

Cognitive Stimulation Therapy (CST) is a low risk psychosocial group intervention and will be delivered via a tablet computer in a Zoom video conference setting as virtual Cognitive Stiulation Therapy (vCST). The intervention is manualised over 15 sessions (one hour per session, 2 sessions per week for 7.5 weeks). The first session focuses on whanaungatanga and familiarisation of technology. Each session starts with introduction, orientation, discussion of current affairs, followed by a main themed cognitively stimulating activity and farewell at the end. Each vCST group has up to six participants and will be facilitated by two trained vCST facilitators; vCST sessions are held in English. Sessions follow a standard format: 1. Welcome & Orientation (5-10 min) – what weekday, month, year, season, weather, etc. 2. Current Affairs Discussion (10 min) – what is happening today? 3. Main Themed Activity (30 min) – see below 4. Closing & Farewell (5-10 min) – karakia / song, reminder of next session Whereby the main themed activity is different for each session. In all instances visuals are used to support the activities. Session 1 – extended welcome, getting to know each other, and becoming familiar with the programme and the online setting, finding a group name and song. Session 2 – Getting to know you (childhood) – remembering where one comes from, siblings, school subjects, first job … Session 3 – Physical games – what sports / activities do you like, recall activities you enjoyed, engage with movements, stretches Session 4 – Sounds – hearing sounds and identifying what makes them, associations with sounds, using words related to sounds, name the sounds you hear Session 5 Food – foods you remember, word phrases about food, name foods good for your brain health, plan a meal together Session 6 – Current affairs – how do you keep up with the news, news in today’s world, identifying what is happening in a picture / screenshot Session 7 – Faces and Scenes – matching faces to names, differences and similarities in faces, what do you like in pictures and why, identify changes between two pictures of a street. Session 8 – Word Associations – supplying a missing word in a list, word associations, completing famous phrases, connect words that relate to each other Session 9 – Being Creative – conversations about different artworks, draw a house and introduce your house to the group Session 10 – Categorising Objects – name a sensation for a sensory category, find pairs of objects, group objects together, name items to take on a holiday, Session 11 – Orientation – name locations and landmarks, name sensory experiences while being in an imaginary place, describe your neighbourhood when stepping outside your home, name places you have been Session 12 – Using Money – guessing cost and income now and in the past, different currencies and exchange rates, payment methods and where you use them. Session 13 – Number Games – name day of the months associated with a specific day, name a number for a specific question, what items appear with a specific number, what is higher or lower, guess the quantity of objects in a jar Session 14 – Word Games – common Te Reo words, find the phrase in a picture, find words that rhyme, form different anagrams Session 15 – Team Quiz – different quizzes Facilitators will have been trained in delivering CST (in person) in a one day workshop. In addition we will provide an additional 3h online training focussed on the on-line modality and its specific requirements. Session attendance will be recorded and follow up calls organised. Also planned are reminder calls for the waitlisted group. It cannot be assumed that the control group' cognitive performance is stable between T1 (base line) and T2 (check out). Therefore measures are taken at Baseline at T1 and at T2 to record any potential change in cognitive performance during the waitlist period. Time between T1 and intervention start, and between end of intervention and T2 is again 2 weeks, resulting in a maximum time between T1 and T2 of 11.5 weeks (2wks+7.5wks+2wks). The study protocol recognised that there is a relatively cost-effective way of an additional T3 (post cool down) assessment, following the same time sequence as between T1 and T2. For the control arm T2 reflects T1 for the intervention arm, and correspondingly T3 reflects T2. The inclusion of T3 is optional for the study and be offered to all consented participants remaining in the study at T2. This additional assessment will gain two more pieces of information: 1) any decay effect in the intervention group following completion of the intervention, and 2) a further effectiveness measure by treating the control group as a separate independent sample to measure the intervention effect.