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DementiaNCT05514678

Cognitive Stimulation Therapy for Dementia

A study testing Cognitive Stimulation Therapy in people with Dementia, run by Ejdane Coskun at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Dementia
What is being tested?
Cognitive Stimulation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Mar 2022to 15 Sep 2022
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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • Presence of any sensory impairment
  • Having a physical health problem that may impair group cohesion and integrity

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Korkut Ata University

    Osmaniye, Center, 80000

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Conditions
Dementia
Being tested
Cognitive Stimulation Therapy
Keywords
Cognitive stimulation therapy, dementia, activities of daily living, depression, life satisfaction
Medical subject headings
Dementia, Depression, Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Stimulation TherapyBehavioural

    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.

Study groups in NCT05514678
Study groupRoleWhat they receive
Cognitive Stimulation TherapyExperimentalIn 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.
Receives: Behavioral: Cognitive Stimulation Therapy
CST nonpharmacological interventionExperimentalIndividuals in the control group will be given two sessions in the 2nd week, and they will continue their daily lives in the following weeks.
Receives: Behavioral: Cognitive Stimulation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 9 weeks

  2. 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.

    Measured: up to 9 weeks

  3. 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.

    Measured: up to 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2022
  2. Study start30 Mar 2022
  3. Primary completion27 May 2022
  4. Study completion15 Sep 2022

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05514678
Sponsor's protocol ID
CST in DEMENTIA
Status last verified
Oct 2022
First submitted
11 Aug 2022
Last updated
14 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27481112

  • Kurz A. [Psychosocial interventions in dementia]. Nervenarzt. 2013 Jan;84(1):93-103; quiz 104-5. doi: 10.1007/s00115-012-3655-x. German.

    PubMed 23306213

  • 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.

    PubMed 35149325

  • 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.

    PubMed 22573599

  • 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.

    PubMed 22889599

  • 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.

    PubMed 30336993

  • 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.

    PubMed 1202204

  • 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 9447431

  • MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

    PubMed 14258950

  • 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.

    PubMed 5349366

  • 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.

    PubMed 3337862

  • 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.

    PubMed 16367493

  • 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.

    PubMed 31930518

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Stimulation Therapy in people with Dementia, run by Ejdane Coskun at 1 site in Turkey (Türkiye).

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 6 inclusion and 2 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: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 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 NCT05514678, which also lists 14 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 14 Oct 2022.

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