Cognitive Stimulation Therapy and Olderly People With Mild Cognitive Impairment

January 21, 2024 updated by: Ejdane Coskun

Evaluation of the Effect of Cognitive Stimulation Therapy on Cognitive Status and Apathy in Olderly People With Mild Cognitive Impairment

The aim of this study is to examine the effect of cognitive stimulation therapy on cognitive status and apathy in elderly individuals with mild cognitive impairment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled experimental study is planned for 30 October - 25 December 2023, with a total of 60 people (30 in the control group and 30 in the intervention group) at the Elderly Care and Rehabilitation Center. The data of the research were collected from the Literature-Based Personal Information Form, Standardized Mini Mental Test (SMMT), Apathy Assessment Scale. Approval from the Clinical Research Ethics Committee and written permission from the participants were obtained to conduct the study. Individuals in the intervention group started with introduction and in the first week, pre-test administration and CST will be administered twice for 45 minutes.

For the next 7 weeks, it will be carried out for one week, with the introduction and pre-test application for individuals in the control group in the first week. They will continue their daily lives in two sessions for one week and two days. They will continue their lives in the following weeks.

Written informed consent form will be given to all individuals in the study. It will start after information about the measurement tools is given.

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

  • Turkey
    • Korkut Ata University
      • Osmaniye, Korkut Ata University, Turkey, 80000
        • Türkiye

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

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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
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.
Behavioral: Cognitive Stimulation Therapy
Cognitive Stimulation Therapy 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 in progress10 min. 45 minutes in total, including the ending.
Other Names:
  • CST nonpharmacological intervention
No Intervention: CST nonpharmacological intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized Mini Mental Test (SMMT)
Time Frame: up to 9 weeks
This test consists of 11 items grouped into five subgroups measuring cognitive functions: orientation, recording memory, attention and calculation, recall and language. In SMMT, which is evaluated out of a total of 30 points, one point is given for each correct answer. Although scores of 23/24 for SMMT are considered the limit score for dementia; SMMT score between 18-23 points is considered as mild stage, 10-17 points as moderate stage, and 10 points or less as severe dementia.
up to 9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apathy Rating Scale (ARS)
Time Frame: up to 9 weeks
ARS focuses on the hobbies and pursuits of the individual in his daily life and his enjoyment of them, and measures his loss in these areas.ARS contains a total of 18 items and provides a four-point Likert type measurement. Scores are given between 1 and 4, with 1 representing not at all characteristic and 4 representing very characteristic.The 6th, 10th and 11th items of the scale are in the reverse direction and scoring is done in the reverse direction accordingly.The total score of ARS is found by summing the scores obtained from each of the items and is 18-72.
up to 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ejdane Coskun

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.

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)

October 30, 2023

Primary Completion (Actual)

December 25, 2023

Study Completion (Actual)

December 25, 2023

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 3, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cst

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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