Advanced Cognitive Stimulation Therapy (ACST)

Study Overview
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Brief Summary
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This study is a feasibility randomised controlled trial (RCT) for an evidence-based intervention for people with moderate to severe dementia. The psychosocial intervention is adapted from Cognitive Stimulation Therapy (CST) and developed within the Medical Research Council (MRC) framework.

Detailed Description
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The World Health Organization calls for an increase of psychosocial interventions for dementia-a global epidemic. Cognitive Stimulation Therapy (CST) is the only non-pharmacological therapy recommended by the National Institute for Health and Care Excellence for improving cognition for mild to moderate dementia. However, there is little guidance on how to maximise cognition for severe dementia. Advanced Cognitive Stimulation Therapy (ACST) will be the first evidence-based complex intervention for moderate to severe dementia developed within the Medical Research Council (MRC) framework and building upon CST's key principles. This feasibility randomised controlled trial (RCT) aims to 1) evaluate the feasibility of ACST 2) explore if ACST can improve the cognitive function, and QoL, as well as other outcomes including behaviour, engagement, and communication, for people with moderate to severe dementia. A sample of 32 participants will be recruited, where 16 will be randomly allocated to ACST, and 16 to treatment as usual (TAU). Data will be collected pre and post the 7-week intervention period. Improving cognition and QoL for people with moderate to severe dementia is vital because dementia's prevalence is projected to reach 152 million by 2050, resulting in excessive excess disability.

Official Title
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Feasibility Randomised Controlled Trial (RCT) of Advanced Cognitive Stimulation Therapy (ACST) for People With Moderate to Severe Dementia

Conditions
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DEM, Dementia, Vascular, Dementia, Mixed, Dementia With Lewy Bodies, Dementia Frontal, Dementia Severe, Dementia Moderate, Dementia of Alzheimer Type, Dementia

Intervention / Treatment
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* Other: Advanced Cognitive Stimulation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Diagnosis of dementia, according to the DSM-IV SMMSE ≤ 12 Ability to communicate in English Ability to complete outcome measures Not having major physical illness or disability that affects participation Consultee is willing and able to provide written informed consent if the participant is not able to provide consent. Ability to remain in a group for around an hour (e.g. no challenging behaviour) Exclusion Criteria: Illness and disability that affects participation (as deemed by the researcher or attending care home staff) SMMSE < 5 Participation in other psychosocial intervention studies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advanced Cognitive Stimulation Therapy<br>Advanced Cognitive Stimulation Therapy (ACST), a psychosocial intervention, is the modified version of CST for people with moderate and severe dementia. Activities consist of more multisensory stimulation elements than the original CST. ACST will be prescribed to participants 45-minutes per week, biweekly for 7 weeks. The intervention will be delivered by two facilitators, such as a research staff, clinical psychologist trainee or care home staff. | Other: Advanced Cognitive Stimulation Therapy<br>* An adapted version of Cognitive Stimulation Therapy for people with moderate to severe dementia.<br>|
| No Intervention: Treatment as usual<br>Standard care in care homes | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment (feasibility of ACST) | 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 ACST) | Retention rate of at least 75% of participants at 8-week follow-up. | Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years | 
| Negative or adverse events (acceptability of ACST) | Any negative or adverse events related to the intervention | Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years | 
| Intervention fidelity (acceptability of ACST) | Facilitator's completion of the fidelity checklist following each session | Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years | 
| Intervention fidelity (acceptability of ACST) | Video recording 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 analysed post-intervention; through study completion, 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive function | Exploratory primary outcome; measured pre and post intervention with Standardised Mini-Mental State Examination (Molloy & Standish, 1997) and Test for Severe Impairment (Albert & Cohen, 1992). SMMSE has 11 questions with scores from 0 to 30, where a low score indicates poor performance. TSI has six domains: motor performance, language comprehension, language production, memory, general knowledge, and conceptualisation. Each domain has a maximum score of 4, and a higher score indicates better cognitive ability. | Pre test (baseline: week 0) and post test (week 8) | 
| Change in quality of life | Exploratory primary 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. | Pre test (baseline: week 0) and post test (week 8) | 
| Change in behaviour | Exploratory secondary outcome; measured pre and post test with the Neuropsychiatric Inventory (Cummings et al., 1997). NPI consists of 12 domains. Each question asks for a frequency of symptoms on a 4-point score, severity on a 3-point score, and distress on a 5-point scale. Higher score denotes higher frequency and severity. | Pre test (baseline: week 0) and post test (week 8) | 
| Change in communication abilities | Exploratory secondary outcome; measured pre and post test with the Holden Communication Scale (Holden & Woods, 1995). Each item contains is on a 5 point scale, and the questionnaire has a maximum score of 48, where a higher score indicates difficulties in communication. | Pre test (baseline: week 0) and post test (week 8) | 
| Change in engagement | Exploratory secondary outcome; measured with the Group Observational Measurement of Engagement Tool (Cohen-Mansfield et al., 2017). GOME consists of 5-domains: attendance, engagement, active participation, attitude, and sleep. Each item is measured on a 4- or 7-point Likert scale from 0, none of the time, to 6, all of the time. | Evaluated by facilitator after every other session, and independent researcher through recordings; through study completion, up to 24-months | 
| Change in overall well-being | Exploratory secondary outcome; measured with the Adapted Greater Cincinnati Chapter Well-Being Observation Tool (Adapted GCCWBOT) (Kinney & Rentz, 2005). The facilitator or independent researcher will assess 4 participants at a time. Each evaluation will be 62 minutes, and 8 domains will be assessed: interest, attention, pleasure, self-esteem, normalcy, disengagement, sadness, and negative affect. | Evaluated by assessor through video recordings for every session; through study completion, 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Randomized Controlled Trial, Cognitive Stimulation, Moderate to severe dementia