Cognitive Stimulation Therapy for Dementia
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cognitive Stimulation Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring Cognitive stimulation therapy, dementia, activities of daily living, depression, life satisfaction
Eligibility Criteria
Inclusion Criteria:
- Having been diagnosed with dementia according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM V) by a physician
- Agree to participate in the study
- Being literate and speaking Turkish fluently
- Have communication and understanding skills
- Standardized Mini Mental Test result being between 18-23 points
- Having adequate vision and hearing functions for group participation
Exclusion Criteria:
- Presence of any sensory impairment
- Having a physical health problem that may impair group cohesion and integrity
Sites / Locations
- Korkut Ata University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cognitive Stimulation Therapy
CST nonpharmacological intervention
Arm Description
In the 2nd, 3rd, 4th, 6th, 7th and 8th weeks, IPT implementation twice a week, as two themes, for 7 weeks, with each session of 45 minutes.
Individuals in the control group will be given two sessions in the 2nd week, and they will continue their daily lives in the following weeks.
Outcomes
Primary Outcome Measures
The change of the effect of cognitive stimulation therapy on activities of daily living in individuals in nursing homes with dementia is being assessed.
Barthel index scores range from 0 to 100, 0-20 points; completely addicted, 21 - 61 points; severe addiction, 62 - 90 points; moderate addiction, 91 - 99 points; mild addiction, 100 points; explains independence. In studies using the Barthel Index, a score of 60 was taken as the limit, and scores above 60 explain the ability to function independently. Lawton and Brody Instrumental Daıly Lıfe Actıvıtıes Scale, the scale consists of 8 items and a single sub-dimension. The total score obtained from the scale varies between 0-8. A low score indicates a high level of addiction.
The change of the effect of cognitive stimulation therapy on depression in individuals in nursing homes with dementia is being assessed.
Cornell Dementia for Dementia In this scale, mood-related findings, behavioral changes, physical findings, cyclical functions and intellectual changes are evaluated with 19 items collected in 5 subgroups. Each item is scored between 0-2. A total score of eight and above suggests significant depression.
The change of the effect of cognitive stimulation therapy on life satisfaction in individuals in nursing homes with dementia is being assessed.
In the Satisfaction with Life Scale, a seven-point Likert type scale is graded between "strongly disagree" (1) and "strongly agree" (7). A high score on the scale indicates high life satisfaction.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05514678
Brief Title
Cognitive Stimulation Therapy for Dementia
Official Title
The Effect of Cognitive Stimulation Therapy on Daily Life Activities, Depression and Life Satisfaction in Individuals With Dementia Nursing Home
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
May 27, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ejdane Coskun
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim:
The aim of this study is to reveal the effectiveness of cognitive stimulation therapy on activities of daily living, depression and life satisfaction in individuals with mild dementia living in nursing homes.
Detailed Description
This randomized controlled experimental study was conducted between 30 March-27 May 2022, with a total of 60 individuals (30 in control and 30 in intervention group) living in Adana and Seyhan Nursing Home Elderly Care and Rehabilitation Centers. The data of the study were collected with the Personal Information Form based on the literature, the Standardized Mini Mental Test (SMMT), the Barthel Activities of Daily Living Index, the Lawton and Brody Instrumental Activities of Daily Living (IADL) Scale, the Cornell Dementia in Dementia Scale (CDS) and the Satisfaction with Life Scale. In order to conduct the study, the approval of the Clinical Research Ethics Committee, written institutional permission and written permission from the participants were obtained. The individuals in the intervention group started with the introduction and pre-test application in the first week and applied CST for 45 minutes twice a week for the next 7 weeks, while the individuals in the control group started with the introduction and pre-test application in the first week and performed two sessions for one week and two days and continued their daily lives in the following weeks. The study was terminated in 9 weeks by applying the post-test to both groups in the last week. Due to the 3-month follow-up study, measurements will be made for the last time in September with the SMMT, BADL, IADL, CDS and LDL measurement tools.After being informed about the study, all individuals with dementia were given written informed consent form.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Cognitive stimulation therapy, dementia, activities of daily living, depression, life satisfaction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Stimulation Therapy
Arm Type
Experimental
Arm Description
In the 2nd, 3rd, 4th, 6th, 7th and 8th weeks, IPT implementation twice a week, as two themes, for 7 weeks, with each session of 45 minutes.
Arm Title
CST nonpharmacological intervention
Arm Type
Experimental
Arm Description
Individuals in the control group will be given two sessions in the 2nd week, and they will continue their daily lives in the following weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Stimulation Therapy
Intervention Description
CST consists of 14 sessions, each session with different themes. The materials used in therapy will differ according to the characteristics of each theme. For example; In the theme of physical games, one of the individuals will be selected by voting, and each individual will be asked to choose a song suitable for the theme and introduce himself/herself to the music accompaniment. Then, a small table game will be prepared with the rackets and ball used for table tennis, and individuals will be able to play a round of table tennis with the researcher and their groupmates. Sessions 10 min. introductory part, 25 min. activity section and 10 min. 45 minutes in total, including the ending. in progress.
Primary Outcome Measure Information:
Title
The change of the effect of cognitive stimulation therapy on activities of daily living in individuals in nursing homes with dementia is being assessed.
Description
Barthel index scores range from 0 to 100, 0-20 points; completely addicted, 21 - 61 points; severe addiction, 62 - 90 points; moderate addiction, 91 - 99 points; mild addiction, 100 points; explains independence. In studies using the Barthel Index, a score of 60 was taken as the limit, and scores above 60 explain the ability to function independently. Lawton and Brody Instrumental Daıly Lıfe Actıvıtıes Scale, the scale consists of 8 items and a single sub-dimension. The total score obtained from the scale varies between 0-8. A low score indicates a high level of addiction.
Time Frame
up to 9 weeks
Title
The change of the effect of cognitive stimulation therapy on depression in individuals in nursing homes with dementia is being assessed.
Description
Cornell Dementia for Dementia In this scale, mood-related findings, behavioral changes, physical findings, cyclical functions and intellectual changes are evaluated with 19 items collected in 5 subgroups. Each item is scored between 0-2. A total score of eight and above suggests significant depression.
Time Frame
up to 9 weeks
Title
The change of the effect of cognitive stimulation therapy on life satisfaction in individuals in nursing homes with dementia is being assessed.
Description
In the Satisfaction with Life Scale, a seven-point Likert type scale is graded between "strongly disagree" (1) and "strongly agree" (7). A high score on the scale indicates high life satisfaction.
Time Frame
up to 9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Having been diagnosed with dementia according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM V) by a physician
Agree to participate in the study
Being literate and speaking Turkish fluently
Have communication and understanding skills
Standardized Mini Mental Test result being between 18-23 points
Having adequate vision and hearing functions for group participation
Exclusion Criteria:
Presence of any sensory impairment
Having a physical health problem that may impair group cohesion and integrity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ejdane Coşkun, Lect.
Organizational Affiliation
ejdanecoskun@osmaniye.edu.tr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korkut Ata University
City
Osmaniye
State/Province
Center
ZIP/Postal Code
80000
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
27481112
Citation
Cheng ST. Cognitive Reserve and the Prevention of Dementia: the Role of Physical and Cognitive Activities. Curr Psychiatry Rep. 2016 Sep;18(9):85. doi: 10.1007/s11920-016-0721-2.
Results Reference
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PubMed Identifier
23306213
Citation
Kurz A. [Psychosocial interventions in dementia]. Nervenarzt. 2013 Jan;84(1):93-103; quiz 104-5. doi: 10.1007/s00115-012-3655-x. German.
Results Reference
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Citation
Aslan M, Hocaoğlu C. Psychiatric Problems Associated with Aging and Aging. Duzce University Journal of Health Sciences Institute. 2017);7(1):53-62.
Results Reference
background
PubMed Identifier
35149325
Citation
Saragih ID, Tonapa SI, Saragih IS, Lee BO. Effects of cognitive stimulation therapy for people with dementia: A systematic review and meta-analysis of randomized controlled studies. Int J Nurs Stud. 2022 Apr;128:104181. doi: 10.1016/j.ijnurstu.2022.104181. Epub 2022 Jan 22.
Results Reference
background
PubMed Identifier
22573599
Citation
Aguirre E, Hoare Z, Streater A, Spector A, Woods B, Hoe J, Orrell M. Cognitive stimulation therapy (CST) for people with dementia--who benefits most? Int J Geriatr Psychiatry. 2013 Mar;28(3):284-90. doi: 10.1002/gps.3823. Epub 2012 May 10.
Results Reference
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PubMed Identifier
22889599
Citation
Aguirre E, Woods RT, Spector A, Orrell M. Cognitive stimulation for dementia: a systematic review of the evidence of effectiveness from randomised controlled trials. Ageing Res Rev. 2013 Jan;12(1):253-62. doi: 10.1016/j.arr.2012.07.001. Epub 2012 Aug 7.
Results Reference
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PubMed Identifier
30336993
Citation
Rai H, Yates L, Orrell M. Cognitive Stimulation Therapy for Dementia. Clin Geriatr Med. 2018 Nov;34(4):653-665. doi: 10.1016/j.cger.2018.06.010. Epub 2018 Aug 20.
Results Reference
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PubMed Identifier
1202204
Citation
Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
Results Reference
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PubMed Identifier
9447431
Citation
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.
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PubMed Identifier
14258950
Citation
MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
Results Reference
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PubMed Identifier
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Citation
Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
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Citation
Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.
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Citation
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Citation
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Results Reference
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Links:
URL
http://www.alzheimerdernegi.org.tr/
Description
alzheimer's association
URL
https://www.tuik.gov.tr/
Description
TUİK
URL
https://www.who.int/
Description
WHO
URL
https://www.who.int/news-room/fact-sheets/detail/dementia
Description
WHO DEMENTİA
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Cognitive Stimulation Therapy for Dementia
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