NCT06115785

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.

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 Oct 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2023

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

October 30, 2023

Last Update Submit

January 21, 2024

Conditions

Keywords

Cognitive stimulation therapyMild Cognitive ImpairmentCognitive StatusApathy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Apathy Rating Scale (ARS)

    up to 9 weeks

Study Arms (2)

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.

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.

Interventions

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.

Also known as: CST nonpharmacological intervention
Cognitive Stimulation Therapy

Eligibility Criteria

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

You may qualify if:

  • 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)

Türkiye

Osmaniye, Korkut Ata University, 80000, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Cognitive DysfunctionLethargy

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

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
PhD, Lecturer

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 3, 2023

Study Start

October 30, 2023

Primary Completion

December 25, 2023

Study Completion

December 25, 2023

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations