Advanced Cognitive Stimulation Therapy (ACST)

NCT04550975 | Unknown

• 1 other identifier: 134729
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Change in cognitive function

  Pre test (baseline: week 0) and post test (week 8)

• Change in quality of life

  Pre test (baseline: week 0) and post test (week 8)

• Change in behaviour

  Pre test (baseline: week 0) and post test (week 8)

• Change in communication abilities

  Pre test (baseline: week 0) and post test (week 8)

• Change in engagement

  Evaluated by facilitator after every other session, and independent researcher through recordings; through study completion, up to 24-months

Study Arms (2)

Advanced Cognitive Stimulation Therapy

EXPERIMENTAL

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

Treatment as usual

NO INTERVENTION

Standard care in care homes

Interventions

Advanced Cognitive Stimulation Therapy OTHER

An adapted version of Cognitive Stimulation Therapy for people with moderate to severe dementia.

Advanced Cognitive Stimulation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University College, London: lead

Related Publications (8)

• 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.

  PMID: 9447431 BACKGROUND

• 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.

  PMID: 12021425 BACKGROUND

• 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.

  PMID: 1634695 BACKGROUND

• 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.

  PMID: 9153155 BACKGROUND

• 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.

  PMID: 10648298 BACKGROUND

• 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.

  PMID: 28214783 BACKGROUND

• 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.

  PMID: 16136845 BACKGROUND

• Holden UP, Woods RT. Positive approaches to dementia care. Edinburgh: Churchill Livingstone, 1995.

  BACKGROUND

MeSH Terms

Conditions

Dementia; Dementia, Vascular; Mixed Dementias; Lewy Body Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Aimee Spector, PhD, DClinPsych

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther K Hui, BSc

CONTACT

+447460285290; esther.hui.19@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind. Assessor will be blinded to the study. Due to the nature of the intervention, the facilitator and participants cannot be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 16, 2020
• Study Start: March 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon study completion
• Access Criteria: Email authors