Advanced Cognitive Stimulation Therapy (ACST)

NCT ID: NCT04550975

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-03-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Advanced Cognitive Stimulation Therapy

Intervention Type: OTHER

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

Treatment as usual

Standard care in care homes

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Advanced Cognitive Stimulation Therapy

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aimee Spector, PhD, DClinPsych

Role: PRINCIPAL_INVESTIGATOR

University College, London

Central Contacts

Esther K Hui, BSc

Role: CONTACT

esther.hui.19@ucl.ac.uk

+447460285290

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

Other Identifiers

134729

Identifier Type: -

Identifier Source: org_study_id