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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06115785
Other study ID # CST
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 30, 2023
Est. completion date December 25, 2023

Study information

Verified date January 2024
Source Osmaniye Korkut Ata University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 25, 2023
Est. primary completion date December 25, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Türkiye Osmaniye Korkut Ata University

Sponsors (1)

Lead Sponsor Collaborator
Ejdane Coskun

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Standardized Mini Mental Test (SMMT) 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 Apathy Rating Scale (ARS) 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
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