NCT05808530

Brief Summary

The concept of cognitive stimulation in AD is one of the most popular approaches. Cognitive Stimulation Therapy (CST) is stated to be evidence-based best practice with robust clinical trials, administered according to specific guidelines for individuals with mild to moderate dementia. In this study, it was aimed to investigate the effects of CST application on the levels of apathy, loneliness, anxiety and daily living activities in elderly individuals with Alzheimer's disease. This research was planned in an experimental research design with a single center and pretest posttest control group. The research was planned to be carried out between January 2023 and June 202 at the Moral House of Gaziantep Metropolitan Municipality, Department of Disabled and Health Services. Introductory Information Form, Standardized Mini-Mental Test, Geriatric Anxiety Scale, Apathy Rating Scale, Loneliness Scale and Functional Disability in Dementia Scale will be used in the research. CST will be administered by a researcher trained in therapy, 2 days a week, for a total of 14 sessions of 45-50 minutes. There will be a pre-test before the application, an intermediate test right after the application, and a post-test three months later. Research data will be evaluated in SPSS 25.0 New York package program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

January 14, 2023

Last Update Submit

March 14, 2024

Conditions

Keywords

Alzheimer DiseaseDementiaApathyAnxietyLonelinessCognitive Stimulation Therapy

Outcome Measures

Primary Outcomes (4)

  • The effect of CST on the level of apathy in Alzheimer's patients

    The level of apathy will be measured withAphaty Evaluation Scale in Alzheimer's patients after CST.

    through study completion, an average of 1 year

  • The effect of CST on the level of loneliness in Alzheimer's patients

    The level of loneliness will be measured with a UCLA Loneliness Scale in Alzheimer's patients after CST.

    through study completion, an average of 1 year

  • The effect of CST on the level of anxiety in Alzheimer's patients

    The level of anxiety will be measured with a Geraitric Anxiety Scale in Alzheimer's patients after CST.

    through study completion, an average of 1 year

  • The effect of CST on the level of Activities of Daily Living in Alzheimer's patients

    The level of anxiety will be measured with a Activities of Daily Living Scale in Alzheimer's patients after CST.

    through study completion, an average of 1 year

Study Arms (2)

Intervention arm

EXPERIMENTAL

It is te intervention grup.

Behavioral: Cognitive Stimulation Therapy

no intervention arm

NO INTERVENTION

It is the non intervention group.

Interventions

CST involves the use of standard tasks that focus on cognitive functions, designed to meet varying levels of difficulty in accordance with the individual's ability and rehabilitation. A detailed guide for CST is available for a range of health and care professionals, including care workers, occupational therapists, psychologists, and nurses (https://www.ucl.ac.uk/international-cognitive-stimulation-therapy/) publications/cst-manuals). The CST application consists of 14 sessions of 45-50 minutes, 2 days a week. Intervention Group Week 1=Getting acquainted and applying pre-tests Week 2=Physical games and Sounds Week 3=Childhood and Food Week 4=Current events and Faces / Scenes Week 5=Word association and Creativity Week 6=Categorizing Objects and Orientation Week 7= Money usage and Games Week 8=Word Games and Team Competition Week 9=Closing and post-test application

Intervention arm

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older,
  • Having a mild Alzheimer's diagnosis and a Standardized Mini Mental Test score in the range of 18-23,
  • Able to speak and understand Turkish,
  • Hearing, understanding, seeing and speaking problems,
  • Having no physical illness or disability to participate in group work,
  • Have not participated in the CST program before, Individuals who volunteer to participate in the research will be included in the study.

You may not qualify if:

  • Have not attended at least two sessions of the CST program,
  • Patients who refuse/want to leave the CST program will be excluded from the study by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, 27000, Turkey (Türkiye)

Location

Related Publications (14)

  • Juarez-Cedillo T, Gutierrez-Gutierrez L, Sanchez-Hurtado LA, Martinez-Rodriguez N, Juarez-Cedillo E. Randomized Controlled Trial of Multi-Component Cognitive Stimulation Therapy (SADEM) in Community-Dwelling Demented Adults. J Alzheimers Dis. 2020;78(3):1033-1045. doi: 10.3233/JAD-200574.

    PMID: 33104028BACKGROUND
  • Zhao QF, Tan L, Wang HF, Jiang T, Tan MS, Tan L, Xu W, Li JQ, Wang J, Lai TJ, Yu JT. The prevalence of neuropsychiatric symptoms in Alzheimer's disease: Systematic review and meta-analysis. J Affect Disord. 2016 Jan 15;190:264-271. doi: 10.1016/j.jad.2015.09.069. Epub 2015 Oct 24.

    PMID: 26540080BACKGROUND
  • Cerejeira J, Lagarto L, Mukaetova-Ladinska EB. Behavioral and psychological symptoms of dementia. Front Neurol. 2012 May 7;3:73. doi: 10.3389/fneur.2012.00073. eCollection 2012.

    PMID: 22586419BACKGROUND
  • Sobral SR, Sobral M. Computerized cognitive stimulation for people with dementia or with mild cognitive impairment: a bibliometric review. Dement Neuropsychol. 2021 Jan-Mar;15(1):28-40. doi: 10.1590/1980-57642021dn15-020003.

    PMID: 33907595BACKGROUND
  • Perkins L, Fisher E, Felstead C, Rooney C, Wong GHY, Dai R, Vaitheswaran S, Natarajan N, Mograbi DC, Ferri CP, Stott J, Spector A. Delivering Cognitive Stimulation Therapy (CST) Virtually: Developing and Field-Testing a New Framework. Clin Interv Aging. 2022 Feb 9;17:97-116. doi: 10.2147/CIA.S348906. eCollection 2022.

    PMID: 35173425BACKGROUND
  • Fukushima RLM, do Carmo EG, Pedroso RDV, Micali PN, Donadelli PS, Fuzaro G Junior, Venancio RCP, Viola J, Costa JLR. Effects of cognitive stimulation on neuropsychiatric symptoms in elderly with Alzheimer's disease: A systematic review. Dement Neuropsychol. 2016 Jul-Sep;10(3):178-184. doi: 10.1590/S1980-5764-2016DN1003003.

    PMID: 29213453BACKGROUND
  • Khan Z, Corbett A, Ballard C. Cognitive stimulation therapy: training, maintenance and implementation in clinical trials. Pragmat Obs Res. 2014 Apr 5;5:15-19. doi: 10.2147/POR.S56000. eCollection 2014.

    PMID: 27774025BACKGROUND
  • Wong GHY, Yek OPL, Zhang AY, Lum TYS, Spector A. Cultural adaptation of cognitive stimulation therapy (CST) for Chinese people with dementia: multicentre pilot study. Int J Geriatr Psychiatry. 2018 Jun;33(6):841-848. doi: 10.1002/gps.4663. Epub 2017 Jan 11.

    PMID: 29717527BACKGROUND
  • Yang YP, Lee FP, Chao HC, Hsu FY, Wang JJ. Comparing the Effects of Cognitive Stimulation, Reminiscence, and Aroma-Massage on Agitation and Depressive Mood in People With Dementia. J Am Med Dir Assoc. 2016 Aug 1;17(8):719-24. doi: 10.1016/j.jamda.2016.03.021. Epub 2016 May 7.

    PMID: 27168052BACKGROUND
  • Hall L, Orrell M, Stott J, Spector A. Cognitive stimulation therapy (CST): neuropsychological mechanisms of change. Int Psychogeriatr. 2013 Mar;25(3):479-89. doi: 10.1017/S1041610212001822. Epub 2012 Nov 12.

    PMID: 23146408BACKGROUND
  • Chen HM, Tsai LJ, Chao SY, Clark MJ. Study on the Effects of Individualized Learning Therapy on Cognitive Function and Behavioral and Psychological Symptoms of Dementia in the Institutionalized Older Adults. J Nurs Res. 2016 Dec;24(4):300-310. doi: 10.1097/JNR.0000000000000118.

    PMID: 27846102BACKGROUND
  • Lin HC, Yang YP, Cheng WY, Wang JJ. Distinctive effects between cognitive stimulation and reminiscence therapy on cognitive function and quality of life for different types of behavioural problems in dementia. Scand J Caring Sci. 2018 Jun;32(2):594-602. doi: 10.1111/scs.12484. Epub 2017 Sep 7.

    PMID: 28881430BACKGROUND
  • Lok N, Buldukoglu K, Barcin E. Effects of the cognitive stimulation therapy based on Roy's adaptation model on Alzheimer's patients' cognitive functions, coping-adaptation skills, and quality of life: A randomized controlled trial. Perspect Psychiatr Care. 2020 Jul;56(3):581-592. doi: 10.1111/ppc.12472. Epub 2020 Jan 12.

    PMID: 31930518BACKGROUND
  • Martinez-Moreno M, Cerulla N, Chico G, Quintana M, Garolera M. Comparison of neuropsychological and functional outcomes in Alzheimer's disease patients with good or bad response to a cognitive stimulation treatment: a retrospective analysis. Int Psychogeriatr. 2016 Nov;28(11):1821-1833. doi: 10.1017/S104161021600123X. Epub 2016 Aug 9.

    PMID: 27503001BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease 10DementiaLethargyAnxiety DisordersAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTauopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2023

First Posted

April 11, 2023

Study Start

May 1, 2023

Primary Completion

October 30, 2023

Study Completion

December 30, 2023

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations