NCT05514678

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

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

Study Start

First participant enrolled

March 30, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

August 11, 2022

Last Update Submit

October 12, 2022

Conditions

Keywords

Cognitive stimulation therapydementiaactivities of daily livingdepressionlife satisfaction

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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

Study Arms (2)

Cognitive Stimulation Therapy

EXPERIMENTAL

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.

Behavioral: Cognitive Stimulation Therapy

CST nonpharmacological intervention

EXPERIMENTAL

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.

Behavioral: Cognitive Stimulation Therapy

Interventions

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.

CST nonpharmacological interventionCognitive Stimulation Therapy

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korkut Ata University

Osmaniye, Center, 80000, Turkey (Türkiye)

Location

Related Publications (14)

  • 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.

    PMID: 27481112BACKGROUND
  • Kurz A. [Psychosocial interventions in dementia]. Nervenarzt. 2013 Jan;84(1):93-103; quiz 104-5. doi: 10.1007/s00115-012-3655-x. German.

    PMID: 23306213BACKGROUND
  • Aslan M, Hocaoğlu C. Psychiatric Problems Associated with Aging and Aging. Duzce University Journal of Health Sciences Institute. 2017);7(1):53-62.

    BACKGROUND
  • 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.

    PMID: 35149325BACKGROUND
  • 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.

    PMID: 22573599BACKGROUND
  • 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.

    PMID: 22889599BACKGROUND
  • 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.

    PMID: 30336993BACKGROUND
  • 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.

    PMID: 1202204BACKGROUND
  • 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.

    PMID: 9447431BACKGROUND
  • MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

    PMID: 14258950BACKGROUND
  • 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.

    PMID: 5349366BACKGROUND
  • 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.

    PMID: 3337862BACKGROUND
  • 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.

    PMID: 16367493BACKGROUND
  • 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

Related Links

MeSH Terms

Conditions

DementiaDepressionPersonal Satisfaction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Ejdane Coşkun, Lect.

    ejdanecoskun@osmaniye.edu.tr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 24, 2022

Study Start

March 30, 2022

Primary Completion

May 27, 2022

Study Completion

September 15, 2022

Last Updated

October 14, 2022

Record last verified: 2022-10

Locations