Effect of adapted computerized cognitive training on executive functions and anxiety symptoms compared with standard cognitive training in older adults with mild neurocognitive disorder: a randomized clinical trial

ISRCTN	ISRCTN45045597
DOI	https://doi.org/10.1186/ISRCTN45045597
Protocol serial number	CBE06_2024
Sponsor	Universidad de Manizales
Funder	Investigator initiated and funded

Submission date: 03/09/2024
Registration date: 06/09/2024
Last edited: 22/09/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Mild neurocognitive disorder can affect memory, executive functions, and other cognitive abilities while allowing people to maintain relative independence in their daily activities. This study aims to compare the effects of adapted computerized cognitive training and standard cognitive training on executive functions and anxiety symptoms in older adults with mild neurocognitive disorder.

Who can participate?
Adults aged 60 years or older with a diagnosis of mild neurocognitive disorder who meet the eligibility criteria established for the study.

What does the study involve?
Participants will be randomly assigned to one of two groups. One group will receive adapted computerized cognitive training using the Braining program, and the other group will receive standard cognitive training using paper-and-pencil activities and other materials. Both interventions will include 24 individual, face-to-face sessions delivered twice weekly over 12 weeks. Executive functions and anxiety symptoms will be assessed before and immediately after the interventions.

What are the potential benefits and risks of participating?
Participants may experience changes in some of the cognitive abilities exercised during the intervention, although individual benefit cannot be guaranteed. No significant risks are expected. Some participants may experience temporary tiredness, frustration, or discomfort while completing the assessments or training activities.

Where is the study run from?
Plenamente Salud Mental Integral IPS in Manizales, Colombia.

When is the study starting and how long is it expected to run for?
August 2024 to March 2025.

Who is funding the study?
The study is investigator initiated and funded.

Who is the main contact?
María Alexandra Cardona Tangarife: macardonat30829@umanizales.edu.co
Daniel Alfredo Landínez Martínez: dlandinez@umanizales.edu.co

Contact information

Mrs María Alexandra Cardona Tangarife
Public, Scientific, Principal investigator

carrera 9 N° 57 C1 58
Manizales
170001
Colombia

ORCID ID	0000-0001-6877-238X
Phone	+57 (0)3146058597
Email	macardonat30829@umanizales.edu.co

Mr Daniel Alfredo Landinez Martínez
Public, Scientific, Principal investigator

Carrera 9 N| 57 C1-58
Manizales
170001
Colombia

ORCID ID	0000-0002-7265-5052
Phone	+57 (0)3102305063
Email	dlandinez@umanizales.edu.co

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Scientific title	Effect of adapted computerized cognitive training on executive functions and anxiety symptoms compared with standard cognitive training in older adults with mild neurocognitive disorder: a randomized clinical trial
Study acronym	ECAM-TNL
Study objectives	Current study objectives as of 22/09/2026: Main objective To determine the effect of adapted computerized cognitive training on executive functions and anxiety symptoms, compared with standard cognitive training, in older adults with mild neurocognitive disorder receiving care at Plenamente IPS in Manizales. Specific objectives: 1. To describe the sociodemographic and clinical characteristics of older adults with mild neurocognitive disorder receiving care at Plenamente IPS in Manizales 2. To establish executive-function performance and anxiety symptom severity before and after adapted computerized cognitive training 3. To establish executive-function performance and anxiety symptom severity before and after standard cognitive training 4. To compare the pre-intervention and post-intervention changes in executive functions and anxiety symptoms between the group receiving adapted computerized cognitive training and the group receiving standard cognitive training. Null hypothesis: Adapted computerized cognitive training will not have a superior effect to standard cognitive training on executive functions or anxiety symptoms in older adults with mild neurocognitive disorder receiving care at Plenamente IPS in Manizales. Alternative hypothesis: Adapted computerized cognitive training will have a superior effect to standard cognitive training on executive functions and anxiety symptoms in older adults with mild neurocognitive disorder receiving care at Plenamente IPS in Manizales. _____ Previous study objectives: H0: An adapted computerized cognitive training has the same effect on executive function tasks and anxiety symptoms as standard cognitive training in patients with mild neurocognitive disorder (MND) at Plenamente IPS Comprehensive Mental Health in the city of Manizales. H1: An adapted computerized cognitive training has a greater effect on executive function tasks and anxiety symptoms than standard cognitive training in patients with MND at Plenamente IPS Comprehensive Mental Health in the city of Manizales.
Ethics approval(s)	Approved 08/08/2024, Bioethics Committee of the University of Manizales (Carrera 9 N° 19-03, Manizales, 170004, Colombia; +57 (0)8879680; info@umanizales.edu.co), ref: acta CBE06_2024
Health condition(s) or problem(s) studied	Mild neurocognitive disorder
Intervention	Current interventions as of 22/09/2026: Participants will be randomly allocated in a 1:1 ratio to adapted computerized cognitive training or standard cognitive training. Both interventions will consist of 24 individual, face-to-face sessions delivered twice weekly over 12 weeks and supervised by trained neuropsychology professionals. Adapted computerized cognitive training Participants assigned to this group will complete 24 sessions using the Braining program. Each session will last approximately 50 minutes. The program will include six activities designed to exercise executive functions: Cubes, Digits, Find Me, Letters, Change, and Rotation. In the Cubes activity, participants will reproduce sequences of illuminated cubes in the same order. In Digits, they will enter number sequences in reverse order. In Find Me, they will remember and identify the location of a specific letter after the stimuli disappear. In Letters, they will remember the locations of letters presented in a grid. In Change, they will identify the element that differs between two similar sequences. In Rotation, they will identify previously illuminated cubes after a 90-degree rotation. The training difficulty will increase progressively according to each participant’s performance. Correct responses will result in a greater number of stimuli or longer sequences. When errors occur, the difficulty will not decrease; participants will remain at the level reached and continue practising until their performance allows them to advance. Standard cognitive training Participants assigned to the active control group will complete 24 individual sessions delivered twice weekly over 12 weeks. Each session will last approximately 45 to 50 minutes. The intervention will be conducted mainly through paper-and-pencil activities, printed materials, puzzles, figures, cards, and other manipulable materials. The program will target the same executive-function components evaluated in the study: working memory, cognitive flexibility, and inhibitory control. Working memory will be exercised through sequential mental operations, retention and manipulation of information, multiple-step instructions, ordering of words and numbers, reverse sequences, and organization of everyday activities. Cognitive flexibility will be exercised through changes in rules and categories, stimulus classification, alternative problem-solving strategies, and adaptation to changes in instructions. Inhibitory control will be addressed through selective cancellation tasks, stimulus selection according to specific criteria, suppression of automatic responses, incompatible-rule exercises, and decision-making activities requiring participants to stop and consider different alternatives. The activities will be progressively distributed across the 24 sessions and will include structured tasks and everyday situations, such as organizing purchases, planning weekly activities, and managing limited resources. Unlike the computerized program, the standard intervention will not use an automated adaptation algorithm. However, the therapist will provide feedback and adjust the complexity of some exercises according to each participant’s progress while maintaining the sequence and content established in the protocol. _____ Previous interventions: The study will be conducted in the setting of the IPS Plenamente Comprehensive Mental Health using the diagnostic database of this institution. Participant selection will be rigorously carried out with predefined inclusion and exclusion criteria to ensure the homogeneity of the sample. The reason for the random allocation of participants to intervention groups is to ensure that any observed difference in the outcomes of executive functions and anxiety symptoms can be attributed to the interventions and not to confounding factors. Random allocation helps balance baseline characteristics between the groups, minimizing selection bias and enhancing the internal validity of the study. The use of an external and independent collaborator to perform random allocation using the Research Randomizer software (https://www.randomizer.org) ensures impartiality in the distribution of participants, allowing a fair and objective comparison of the intervention effects. The Computerized Cognitive Training Group (Braining) will participate in 50-minute sessions, 2 days a week for 12 weeks, using the Braining program to enhance executive functions. The activities include specific tasks such as sequences of cubes, digits, and letters, focused on memory, attention, and recognition. The Traditional Cognitive Training Group will conduct 24 sessions divided into six phases, focusing on crossing out tasks, solving everyday situations, and practising cognitive strategies.
Intervention type	Behavioural
Primary outcome measure(s)	Current primary outcome(s) as of 22/09/2026: 1. Direct score on Trial 2 of the Alphabetical Ordering Test from the BANFE-2, assessed at baseline and immediately after completion of the 12-week intervention 2. Direct score on Trial 3 of the Alphabetical Ordering Test from the BANFE-2, assessed at baseline and immediately after completion of the 12-week intervention 3. Direct score on the Arithmetic subtest of the WAIS-IV, assessed at baseline and immediately after completion of the 12-week intervention 4. Total direct score on the Digit Span subtest of the WAIS-IV, assessed at baseline and immediately after completion of the 12-week intervention 5. Direct score on the backward condition of the Corsi Block-Tapping Test, assessed at baseline and immediately after completion of the 12-week intervention 6. Direct score on the Spatial Addition subtest of the WMS-IV, assessed at baseline and immediately after completion of the 12-week intervention 7. Composite score on the Working Memory Index of the WAIS-IV, assessed at baseline and immediately after completion of the 12-week intervention 8. Number of perseverative responses on the Card Sorting Test from the BANFE-2, assessed at baseline and immediately after completion of the 12-week intervention 9. Word-colour score on the Stroop Test from the BANFE-2, assessed at baseline and immediately after completion of the 12-week intervention _____ Previous primary outcome(s): 1. Working memory measured using the Working Memory Index of the WAIS-IV (subtests of Arithmetic and Digit Span), the Corsi Blocks test, the Alphabetical Ordering (trials 2 and 3) from the BANFE-2, and the Spatial Addition test from the WMS-IV at baseline and post-intervention 2. Cognitive flexibility measured using the Card Sorting from the BANFE-2 at baseline and post-intervention 3. Inhibitory control measured using the Stroop (Forms A and B) from the BANFE-2 at baseline and post-intervention
Key secondary outcome measure(s)	Current key secondary outcome(s) as of 22/09/2026: Anxiety symptom severity will be assessed using the total score of the Beck Anxiety Inventory (BAI) at baseline and immediately after completion of the 12-week intervention. The BAI total score ranges from 0 to 63, with higher scores indicating greater anxiety symptom severity _____ Previous key secondary outcome(s): Severity of anxiety symptoms measured using the Beck Anxiety Inventory (BAI) at baseline and post-intervention
Completion date	30/03/2025

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	60 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	100
Total final enrolment	29
Key inclusion criteria	Current key inclusion criteria as of 22/09/2026: 1. Adults aged 60 years or older 2. Diagnosis of mild neurocognitive disorder according to DSM-5 criteria, with symptom onset within the previous two years and a neuropsychological diagnosis established at least six months before enrolment in the study 3. Montreal Cognitive Assessment (MoCA) score compatible with mild neurocognitive disorder according to education-adjusted reference values for the Colombian population: 18-21 for primary education or less, 19-23 for secondary education, and 19-24 for higher education 4. Preservation of independence in instrumental activities of daily living, indicated by a score of 7 or 8 on the Lawton and Brody Scale. Mild reductions will be permitted when they do not represent a substantial loss of independence and activities are maintained through greater effort or compensatory strategies 5. Preservation of basic activities of daily living, indicated by a Barthel Index score between 90 and 100 6. At least five years of formal education 7. Beck Anxiety Inventory (BAI) score between 0 and 21 8. Evidence of impairment in at least one of the executive-function indicators evaluated in the study, according to the cut-off scores established in the protocol 9. Sufficient visual and auditory acuity, with usual corrective aids if required, to understand the instructions and complete the assessments and interventions 10. Ability to understand the study procedures and provide written informed consent _____ Previous key inclusion criteria: 1. Diagnosis of MCI according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, with symptom onset within the last 2 years and diagnosed by the neuropsychology department at least 6 months prior to inclusion 2. Score on the Montreal Cognitive Assessment (MOCA) between ≥15.1 and ≤20.5 3. Preservation of complex instrumental activities of daily living with the possibility of using compensatory strategies according to a score of 8 on the Lawton and Brody scale 4. Preservation of basic activities of daily living with a Barthel Index score between 91 and 100, indicating "mild dependence" or "complete independence," sufficient for participation in the study 5. A minimum of 5 years of formal education 6. Mild anxiety symptoms according to the Beck Anxiety Inventory (BAI) score, between 8 and 15 7. Impairment in executive functions according to scores obtained in the study tests (Card Sorting from the BANFE-2: Standardized score ≤7, Alphabetical Ordering from the BANFE-2 (trial 2 and 3): Standardized score ≤7, Digit Retention from the WAIS-IV: Scaled scores ≤7, Arithmetic from the WAIS-IV: Scaled scores ≤7, Corsi Blocks: Scaled score ≤7, Stroop Test Form A and B from the BANFE-2: Standardized score ≤7, Working Memory Index from the WAIS-IV: Scores ≤85) 8. Sufficient visual and/or auditory acuity to perform neuropsychological tests
Key exclusion criteria	1. Associated neurological disorders 2. Scores on the Yesavage Geriatric Depression Scale (GDS-15) that do not indicate moderate to severe depressive symptoms (scores <6) 3. Psychiatric comorbidity other than anxiety symptoms 4. History of addiction within the last 10 years 5. Receiving cognitive training during the last 6 months prior to starting participation in the study 6. Hospitalization in an Intermediate Care or Intensive Care Unit within the last year
Date of first enrolment	09/08/2024
Date of final enrolment	31/12/2024

Locations

Countries of recruitment

Colombia

Study participating centre

Plenamente salud mental integral IPS

-Calle 65 # 23B - 79, Av Lindsay
Manizales - Caldas
170001
Colombia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan	The datasets generated and/or analyzed during the current study will be available as a supplement to the publication of the results

Editorial Notes

22/09/2026: The following changes were made to the study record:
1. The public title was changed from "Impact of a cognitive training program on executive functions and anxious symptomatology in older adults: a study in a mental health institution in Manizales" to "Effect of adapted computerized cognitive training on executive functions and anxiety symptoms compared with standard cognitive training in older adults with mild neurocognitive disorder: a randomized clinical trial".
2. The scientific title was changed from "Effect of adapted computerized cognitive training on executive functions and anxiety symptoms, compared to a standard intervention in patients with mild neurocognitive disorder at a mental health institution in Manizales: a randomized clinical experimental study" to "Effect of adapted computerized cognitive training on executive functions and anxiety symptoms compared with standard cognitive training in older adults with mild neurocognitive disorder: a randomized clinical trial".
3. The study objectives were changed.
4. The Health condition(s) or problem(s) studied was changed from Mild cognitive impairment to Mild neurocognitive disorder.
5. The interventions were changed.
6. The primary outcome(s) were changed.
7. The key secondary outcome(s) were changed.
8. The key inclusion criteria were changed.
9. The total final enrolment was added.
10. The plain English summary was updated to reflect these changes.
06/09/2024: The public title was changed from 'Impact of a cognitive training program on memory and anxiety in elderly patients: a study in a mental health institution in Manizales' to 'Impact of a cognitive training program on executive functions and anxious symptomatology in older adults: a study in a mental health institution in Manizales'.
04/09/2024: Study's existence confirmed by the Bioethics Committee of the University of Manizales.