- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05514678
Cognitive Stimulation Therapy for Dementia
October 12, 2022 updated by: Ejdane Coskun
The Effect of Cognitive Stimulation Therapy on Daily Life Activities, Depression and Life Satisfaction in Individuals With Dementia Nursing Home
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Center
-
Osmaniye, Center, Turkey, 80000
- Korkut Ata University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive Stimulation Therapy
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.
|
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.
|
|
Experimental: CST nonpharmacological intervention
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change of the effect of cognitive stimulation therapy on activities of daily living in individuals in nursing homes with dementia is being assessed.
Time Frame: up to 9 weeks
|
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.
|
up to 9 weeks
|
|
The change of the effect of cognitive stimulation therapy on depression in individuals in nursing homes with dementia is being assessed.
Time Frame: up to 9 weeks
|
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.
|
up to 9 weeks
|
|
The change of the effect of cognitive stimulation therapy on life satisfaction in individuals in nursing homes with dementia is being assessed.
Time Frame: up to 9 weeks
|
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.
|
up to 9 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ejdane Coşkun, Lect., ejdanecoskun@osmaniye.edu.tr
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
- Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Kurz A. [Psychosocial interventions in dementia]. Nervenarzt. 2013 Jan;84(1):93-103; quiz 104-5. doi: 10.1007/s00115-012-3655-x. German.
- Aslan M, Hocaoğlu C. Psychiatric Problems Associated with Aging and Aging. Duzce University Journal of Health Sciences Institute. 2017);7(1):53-62.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 30, 2022
Primary Completion (Actual)
May 27, 2022
Study Completion (Actual)
September 15, 2022
Study Registration Dates
First Submitted
August 11, 2022
First Submitted That Met QC Criteria
August 22, 2022
First Posted (Actual)
August 24, 2022
Study Record Updates
Last Update Posted (Actual)
October 14, 2022
Last Update Submitted That Met QC Criteria
October 12, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CST in DEMENTIA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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