Mild Cognitive ImpairmentNCT06115785
Cognitive Stimulation Therapy and Olderly People With Mild Cognitive Impairment
A study testing Cognitive Stimulation Therapy in people with Mild Cognitive Impairment, run by Ejdane Coskun at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Cognitive Stimulation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2023to 25 Dec 2023
- 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
- 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
Türkiye
Osmaniye, Korkut Ata University, 80000
About this study
Official title: 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Cognitive Stimulation Therapy
- Keywords
- Cognitive stimulation therapy, Mild Cognitive Impairment, Cognitive Status, Apathy
- Medical subject headings
- Cognitive Dysfunction, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Stimulation TherapyBehavioural
Also called CST nonpharmacological intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Stimulation Therapy | Experimental | 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. Receives: Behavioral: Cognitive Stimulation Therapy |
| CST nonpharmacological intervention | No 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 9 weeks
Secondary outcomes (1)
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.
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.
- First posted3 Nov 2023
- Study start30 Oct 2023
- Primary completion25 Dec 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ejdane Coskun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ejdane Coskun, Osmaniye Korkut Ata University
- Investigators
- Ejdane Coşkun, Lect., Principal investigator, ejdanecoskun@osmaniye.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115785
- Sponsor's protocol ID
- CST
- Status last verified
- Jan 2024
- First submitted
- 30 Oct 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Cognitive Stimulation Therapy on Cognitive Status and Apathy in Olderly People With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06115785
- Acronym / sponsor ID
- CST
- Conditions
- Mild Cognitive Impairment
- Keywords
- Cognitive stimulation therapy, Mild Cognitive Impairment, Cognitive Status, Apathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ejdane CoskunUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Stimulation Therapy | Experimental | Behavioral: Cognitive Stimulation TherapyCognitive 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. |
| CST nonpharmacological intervention | No 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Presence of any sensory impairment
- Having a physical health problem that may impair group cohesion and integrity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Stimulation TherapyAlso: CST nonpharmacological interventionCognitive 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. | Behavioural | Cognitive Stimulation Therapy |
Primary outcome
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.
1 secondary outcome
Apathy Rating Scale (ARS)
Time frame: up to 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- WHOLink provided by the sponsor.
- UCL HomeInternational Cognitive Stimulation Therapy (CST) Centre International Cognitive Stimulation Therapy (CST) CentreLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ejdane Coşkun, Lect. principal investigator
ejdanecoskun@osmaniye.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Stimulation Therapy in people with Mild Cognitive Impairment, 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 5 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 23 Jan 2024. 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?
Standardized Mini Mental Test (SMMT) (time frame: up to 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2024.