Cognitive Stimulation Therapy and Olderly People With Mild Cognitive Impairment

Sponsor

Ejdane Coskun (Other)

Overall Status

Recruiting

CT.gov ID

NCT06115785

Collaborator

(none)

Enrollment

Location

Arms

1.8

Anticipated Duration (Months)

32.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment	Behavioral: Cognitive Stimulation Therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 30, 2023

Anticipated Primary Completion Date :

Dec 25, 2023

Anticipated Study Completion Date :

Dec 25, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Standardized Mini Mental Test (SMMT) [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.

Secondary Outcome Measures

Apathy Rating Scale (ARS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Türkiye	Osmaniye	Korkut Ata University	Turkey	80000

Sponsors and Collaborators

Ejdane Coskun

Investigators

Principal Investigator: Ejdane Coşkun, Lect., ejdanecoskun@osmaniye.edu.tr

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Ejdane Coskun, PhD, Lecturer, Osmaniye Korkut Ata University

ClinicalTrials.gov Identifier:

NCT06115785

Other Study ID Numbers:

First Posted:

Nov 3, 2023

Last Update Posted:

Nov 3, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ejdane Coskun, PhD, Lecturer, Osmaniye Korkut Ata University

Cognitive stimulation therapy

Mild Cognitive Impairment

Cognitive Status

Apathy

Additional relevant MeSH terms:

Cognitive Dysfunction

Study Results

No Results Posted as of Nov 3, 2023