Clinical trial NCT04550975: Advanced Cognitive Stimulation Therapy (ACST)
Official title: Feasibility Randomised Controlled Trial (RCT) of Advanced Cognitive Stimulation Therapy (ACST) for People With Moderate to Severe Dementia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: DEM
Dementia
Dementia, Vascular
Dementia, Mixed
Dementia With Lewy Bodies
Dementia Frontal
Dementia Severe
Dementia Moderate
Dementia of Alzheimer Type
Keywords: Dementia
Randomized Controlled Trial
Cognitive Stimulation
Moderate to severe dementia
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18
2. Diagnosis of dementia, according to the DSM-IV
3. SMMSE ≤ 12
4. Ability to communicate in English
5. Ability to complete outcome measures
6. Not having major physical illness or disability that affects participation
7. Consultee is willing and able to provide written informed consent if the participant is not able to provide consent.
8. Ability to remain in a group for around an hour (e.g. no challenging behaviour)

Exclusion Criteria:

1. Illness and disability that affects participation (as deemed by the researcher or attending care home staff)
2. SMMSE \< 5
3. Participation in other psychosocial intervention studies

Primary outcomes:
measure: Recruitment (feasibility of ACST)
timeFrame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
measure: Retention rate (feasibility of ACST)
timeFrame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
measure: Negative or adverse events (acceptability of ACST)
timeFrame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
measure: Intervention fidelity (acceptability of ACST)
timeFrame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
measure: Intervention fidelity (acceptability of ACST)
timeFrame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Secondary outcomes:
measure: Change in cognitive function
timeFrame: Pre test (baseline: week 0) and post test (week 8)
measure: Change in quality of life
timeFrame: Pre test (baseline: week 0) and post test (week 8)
measure: Change in behaviour
timeFrame: Pre test (baseline: week 0) and post test (week 8)
measure: Change in communication abilities
timeFrame: Pre test (baseline: week 0) and post test (week 8)
measure: Change in engagement
timeFrame: Evaluated by facilitator after every other session, and independent researcher through recordings; through study completion, up to 24-months
measure: Change in overall well-being
timeFrame: Evaluated by assessor through video recordings for every session; through study completion, 2 years
Other outcomes:
Locations:
Study officials:
affiliation: University College, London
name: Aimee Spector, PhD, DClinPsych
role: PRINCIPAL_INVESTIGATOR
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