Home » Trials » SLCTR/2024/004

Effectiveness of maintenance cognitive stimulation therapy on cognitive function and electrophysiological markers among older adults with dementia : a randomized control trial.


SLCTR Registration Number


Date of Registration

15 Feb 2024

The date of last modification

Feb 14, 2024

Application Summary

Scientific Title of Trial

Effectiveness of maintenance cognitive stimulation therapy on cognitive function and electrophysiological markers among older adults with dementia : a randomized control trial.

Public Title of Trial

Effectiveness of maintenance cognitive stimulation therapy (CST) on cognitive function, and frequency of EEG wave pattern in comparison to initial CST among older adults with mild to moderate dementia; A randomized control trial.

Disease or Health Condition(s) Studied


Scientific Acronym


Public Acronym


Brief title

Universal Trial Number


Any other number(s) assigned to the trial and issuing authority

IRB3-113/2566 Faculty of Nursing, Burapha University

Trial Details

What is the research question being addressed?

What is the impact of maintenance cognitive stimulation therapy (CST) on cognitive function and frequency EEG wave pattern compared to initial CST alone among older adults with mild to moderate dementia?

Type of study


Study design


Randomized controlled trial


Masking not used


Standard therapy/practice





Study Phase

Not Applicable

Intervention(s) planned

This study will be undertaken in the government elderly nursing homes in Northeast region of Thailand. There are two steps in obtaining the sample for this study. A simple random sampling will be done by the RA during the first step to randomize one from three nursing homes. Then the elderly in the selected nursing home will be randomly assigned into experimental group and control group by using the coin tossing method. Participants in the intervention group will receive the initial cognitive stimulation therapy (CST), and the extension of the maintenance cognitive stimulation therapy (MCST) program. Participants in the control group will receive only the initial CST program, and usual care.

The MCST program includes the regular initial CST program along with an extension of the additional maintenance sessions. Hence there will be twice-a-week group interventions during the overall 15 weeks and this includes 30 themed sessions. The initial CST program consists of fourteen sessions which are 45-min sessions, held twice a week over 7 weeks. Also, an extension of the MCST program consists of a further sixteen, 45-min sessions, held twice a week over 8 weeks. These programs are designed using the theoretical concepts of reality orientation (RO)/cognitive stimulation. The intervention aims to improve cognitive function through a variety of cognitive tasks that involve executive function, multisensory stimulation, and reminiscence as an aid for orientation. The 14 themed sessions activities of the initial CST program include: 1) physical games, 2) sounds, 3) childhood memories, 4) food, 5) current affairs, 6) faces and scenes, 7) word association, 8) creativity, 9) categorizing objects, 10) orientation, 11) using money, 12) number games, 13) word games, and 14) team games. The 16 themed MCST sessions, in addition to the initial CST course, will run in the same way as the original CST course. Each session covers a different topic with a range of activities. The 16 themed sessions activities include: 1) my life (childhood), 2) current affairs (A), 3) current affairs (B), 4) using objects (A), 5) number game, 6) team games/quiz, 7) music session, 8) physical games, 9) categorizing objects, 10) using objects (B), 11) useful tips, 12) golden expressions cards (A), 13) golden expressions cards (B), 14) opinions on different types of art, 15) famous faces, and 16) word completion.

Activities of each session is as follows:

Session 1, 22: Physical games The researcher encourages the participants to introduce themselves to the group, mention their favorite team, meal, color, etc. Supporting self perception and playing catch with a ball until the music stops are also included.

Session 2, 21: Sounds and Music Matching the sounds (of creatures, objects, and so forth) with the relevant photographs, singing a song with or without anybody, moving an object (fork, spoon, etc.) with the beat of an instrumental.

Session 3, 15: Childhood memories Remembering the characteristics, moments, foods and games in childhood, encouraging the patients to talk, draw.

Session 4: Food Tasting and remembering foods with different tastes (e.g., jam, bread, chocolate, and yogurt), completing the food names, categorizing the foods, creating new names for food.

Session 5, 16, 17: Current affairs Making comments on the news in the newspapers, stating opinions, making comments on predetermined questions covering up-to-date issues.

Session 6, 29: faces and scenes Remembering the photographs of celebrities, archeological sites and historical places, making assessment about the photographs (who is older or where would you like to be?); Creating a moment relevant to the photographs and sharing this moment with the group.

Session 7, 30: Word association Completing the words (places, proverbs, celebrities, words indicating quantities, and so forth), and lyrics and melody of a song.

Session 8, 25, 28: Creativity and Useful tips Washing, peeling, chopping, mixing, and serving a fruit, making leaf prints, planting flowers in a pot.

Session 9, 18, 23: Categorizing objects Estimating the names in a certain category (eg, male names starting with A), writing on a board, categorizing the pictures in different categories by their colors, areas of usage, initials, and so forth.

Session 10: Orientation Asking questions to ensure orientation (categorizing by their colors, areas of usage, initials, etc), discussing on the old and new pictures of where they live or lived, asking questions about where they traveled.

Session 11, 24 : Using money and objects Estimating, reasoning, calculating and comparing the real and up-to-date prices of things (fruits, vegetables, beverages, stationery equipment, valuable objects, etc) to the old figures.

Session 12, 19: Number games Playing cards, estimating the card numbers, estimating the total sum of the money in a jar.

Session 13, 26, 27: Word games Reading stories/newspaper, playing hangman, doing puzzles, discussions etc.

Session 14, 20: Team games Creative activities: painting, coloring decorating, cooking, playing games with a team, rewarding the winning team.

Inclusion criteria

  1. Male and females age > 60 years old
  2. Living in a nursing home for at least 1 month
  3. Mild to moderate dementia with score of 10 to 24 on the MMSE
  4. Ability to communicate and understand communication which will be judged by the participants' understanding of the researcher’s instructions during the baseline assessment,
  5. Ability to read and write in Thai language
  6. Ability to see and hear well enough to follow conversations/comment on visual material, and complete the neuropsychological tests.

Exclusion criteria

  1. Learning disability defined by the DSM-5 diagnostic criteria for Specific Learning Disorder (SLD)
  2. Communication difficulties that is likely to impede participation,
  3. Major physical illness or disability severe enough to impede travel to the group or to sit comfortably in a group environment for one hour.

Primary outcome(s)


Cognitive function assessed by the Alzheimer’s Disease Assessment Scale - Cognition Subscale (ADAS-Cog). The ADAS-Cog, is the standard cognitive test used in clinical trials for dementia. 11 tasks that include both subject-completed tests and observer-based assessments. Together these tasks assess the cognitive domains of memory, language, and praxis. Specific tasks include word recall, naming objects and fingers, commands, constructional praxis, ideational praxis, orientation, word recognition, and language.


Week 0, 7, 15


Secondary outcome(s)


Absolute (V2/Hz) power (AP) density, relative power (RP) density and spectral power (Power spectral) of the EEG wave form.


Week 0, 7, 15


Target number/sample size

30 (15 in each arm)

Countries of recruitment


Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status


Funding source

Regulatory approvals

State of Ethics Review Approval



Date of Approval


Approval number


Details of Ethics Review Committee

Name: The ethics review committee of Institutional Review Board Graduate Studies, Faculty of Nursing, Burapha University
Institutional Address:Burapha University, 169 Longhaad Bangsaen Road, Saensuk, Mueang, ChonBuri 20131
Email: 63810002@go.buu.ac.th

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Wasan Gawgleun
Ph.D. candidate
Burapha University, 169 Longhaad Bangsaen Road, Saensuk, Mueang, ChonBuri 20131

Contact Person for Public Queries

Dr. Pornchai Jullamate
Associate Professor and Dean
Burapha University, 169 Longhaad Bangsaen Road, Saensuk, Mueang, ChonBuri 20131


Primary study sponsor/organization

Burapha University

169 Longhaad Bangsaen Road, Saensuk, Mueang, ChonBuri 20131

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Study protocol available


Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results