Advanced Cognitive Stimulation Therapy (ACST)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dementia; Dementia, Vascular; Dementia, Mixed; Dementia With Lewy Bodies; Dementia of Alzheimer Type; Dementia Moderate; Dementia Severe; Dementia Frontal; DEM
• Intervention / Treatment: Other: Advanced Cognitive Stimulation Therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esther K Hui, BSc; Phone Number: +447460285290; Email: esther.hui.19@ucl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Advanced Cognitive Stimulation Therapy; 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; An adapted version of Cognitive Stimulation Therapy for people with moderate to severe dementia.
No Intervention: Treatment as usual; Standard care in care homes

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Principal Investigator: Aimee Spector, PhD, DClinPsych, University College, London

Publications and helpful links

General Publications

• Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.
• Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.
• Wood S, Cummings JL, Hsu MA, Barclay T, Wheatley MV, Yarema KT, Schnelle JF. The use of the neuropsychiatric inventory in nursing home residents. Characterization and measurement. Am J Geriatr Psychiatry. 2000 Winter;8(1):75-83. doi: 10.1097/00019442-200002000-00010.
• Molloy DW, Standish TI. A guide to the standardized Mini-Mental State Examination. Int Psychogeriatr. 1997;9 Suppl 1:87-94; discussion 143-50. doi: 10.1017/s1041610297004754.
• Kinney JM, Rentz CA. Observed well-being among individuals with dementia: Memories in the Making, an art program, versus other structured activity. Am J Alzheimers Dis Other Demen. 2005 Jul-Aug;20(4):220-7. doi: 10.1177/153331750502000406.
• Holden UP, Woods RT. Positive approaches to dementia care. Edinburgh: Churchill Livingstone, 1995.
• Albert M, Cohen C. The Test for Severe Impairment: an instrument for the assessment of patients with severe cognitive dysfunction. J Am Geriatr Soc. 1992 May;40(5):449-53. doi: 10.1111/j.1532-5415.1992.tb02009.x.
• Cohen-Mansfield J, Hai T, Comishen M. Group engagement in persons with dementia: The concept and its measurement. Psychiatry Res. 2017 May;251:237-243. doi: 10.1016/j.psychres.2017.02.013. Epub 2017 Feb 6.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 10, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Dementia; Randomized Controlled Trial; Cognitive Stimulation; Moderate to severe dementia
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Tauopathies; Intracranial Arterial Diseases; Intracranial Arteriosclerosis; Leukoencephalopathies; Dementia; Alzheimer Disease; Lewy Body Disease; Dementia, Vascular
• Other Study ID Numbers: 134729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Study results and IPD will be published in a doctoral thesis, peer-reviewed journals, and presented at conferences, and disseminated to the public through information sheets. Participants who indicate their interest in receiving further information regarding dissemination will be sent a letter with the main findings of the study upon completion. Other researchers can email authors for IPD.
• IPD Sharing Time Frame: Upon study completion
• IPD Sharing Access Criteria: Email authors
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No