DEMNCT04550975
Advanced Cognitive Stimulation Therapy (ACST)
A study testing Advanced Cognitive Stimulation Therapy in people with DEM and Dementia, run by University College, London.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- DEM, Dementia, Dementia, Vascular
- What is being tested?
- Advanced Cognitive Stimulation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Illness and disability that affects participation (as deemed by the researcher or attending care home staff)
- SMMSE < 5
- Participation in other psychosocial intervention studies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Advanced Cognitive Stimulation Therapy
- Keywords
- Dementia, Randomized Controlled Trial, Cognitive Stimulation, Moderate to severe dementia
- Medical subject headings
- Dementia, Dementia, Vascular, Mixed Dementias, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Cognitive Stimulation TherapyOther
An adapted version of Cognitive Stimulation Therapy for people with moderate to severe dementia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Advanced Cognitive Stimulation Therapy |
| Treatment as usual | No intervention | Standard care in care homes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment (feasibility of ACST)
Feasibility of recruitment by successful recruitment of the target sample of 32 in a 24-month period.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Evaluated by assessor through video recordings for every session; through study completion, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Mar 2021 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DEMStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aimee Spector, PhD, DClinPsych, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550975
- Sponsor's protocol ID
- 134729
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 9447431Logsdon 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.
PubMed 12021425Albert 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.
PubMed 1634695Cummings 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.
PubMed 9153155Wood 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.
PubMed 10648298Cohen-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.
PubMed 28214783Kinney 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.
PubMed 16136845Holden UP, Woods RT. Positive approaches to dementia care. Edinburgh: Churchill Livingstone, 1995.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Randomised Controlled Trial (RCT) of Advanced Cognitive Stimulation Therapy (ACST) for People With Moderate to Severe Dementia
- ClinicalTrials.gov ID
- NCT04550975
- Acronym / sponsor ID
- 134729
- Conditions
- DEM, Dementia, Dementia, Vascular, Dementia, Mixed, Dementia With Lewy Bodies, Dementia Frontal
- Keywords
- Dementia, Randomized Controlled Trial, Cognitive Stimulation, Moderate to severe dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced Cognitive Stimulation Therapy | Experimental | Other: Advanced Cognitive Stimulation TherapyAdvanced 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. |
| Treatment as usual | No intervention | –Standard care in care homes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18
- Diagnosis of dementia, according to the DSM-IV
- SMMSE ≤ 12
- Ability to communicate in English
- Ability to complete outcome measures
Key exclusion criteria (3 listed)
- Illness and disability that affects participation (as deemed by the researcher or attending care home staff)
- SMMSE < 5
- Participation in other psychosocial intervention studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced Cognitive Stimulation TherapyAn adapted version of Cognitive Stimulation Therapy for people with moderate to severe dementia. | Other | Advanced Cognitive Stimulation Therapy |
Primary outcome
Recruitment (feasibility of ACST)
Time frame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Feasibility of recruitment by successful recruitment of the target sample of 32 in a 24-month period.
Retention rate (feasibility of ACST)
Time frame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Retention rate of at least 75% of participants at 8-week follow-up.
Negative or adverse events (acceptability of ACST)
Time frame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Any negative or adverse events related to the intervention
Intervention fidelity (acceptability of ACST)
Time frame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Facilitator's completion of the fidelity checklist following each session
Intervention fidelity (acceptability of ACST)
Time frame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Video recording of all sessions and an independent researcher rating fidelity with a random 10% of the recordings.
6 secondary outcomes
Change in cognitive function
Time frame: Pre test (baseline: week 0) and post test (week 8)
Change in quality of life
Time frame: Pre test (baseline: week 0) and post test (week 8)
Change in behaviour
Time frame: Pre test (baseline: week 0) and post test (week 8)
Change in communication abilities
Time frame: Pre test (baseline: week 0) and post test (week 8)
Change in engagement
Time frame: Evaluated by facilitator after every other session, and independent researcher through recordings; through study completion, up to 24-months
Change in overall well-being
Time frame: Evaluated by assessor through video recordings for every session; through study completion, 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 9447431Molloy 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.
- Background: PubMed 12021425Logsdon 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.
- Background: PubMed 1634695Albert 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.
- Background: PubMed 9153155Cummings 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.
- Background: PubMed 10648298Wood 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.
- Background: PubMed 28214783Cohen-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.
- Background: PubMed 16136845Kinney 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.
- BackgroundHolden UP, Woods RT. Positive approaches to dementia care. Edinburgh: Churchill Livingstone, 1995.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aimee Spector, PhD, DClinPsych principal investigator
University College, London
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Cognitive Stimulation Therapy in people with DEM and Dementia, run by University College, London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esther K Hui, BSc (+447460285290, esther.hui.19@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (feasibility of ACST) (time frame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04550975, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.