Impact of a cognitive training program on executive functions and anxious symptomatology in older adults: a study in a mental health institution in Manizales

ISRCTN ISRCTN45045597
DOI https://doi.org/10.1186/ISRCTN45045597
Secondary identifying numbers CBE06_2024
Submission date
03/09/2024
Registration date
06/09/2024
Last edited
06/09/2024
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
This study focuses on individuals with mild cognitive impairment (MCI), a condition that can affect memory and other cognitive abilities. The objective of the research is to evaluate whether a computer-based cognitive training program can better improve thinking skills (executive functions) and reduce anxiety symptoms compared with a traditional cognitive training program.

Who can participate?
Men and women diagnosed with mild cognitive impairment

What does the study involve?
The study will compare two types of cognitive training: one conducted on a computer and another using traditional methods. Participants will be divided into two groups, one for each type of training, and the study will last for 12 weeks. During this time, their cognitive abilities and anxiety levels will be assessed at the beginning and end of the program to determine which type of training yields better results.

What are the potential benefits and risks of participating?
Participants may improve their cognitive abilities and experience reduced anxiety by the end of the study. The treatments pose no significant risks, although some participants may feel tired or frustrated during training sessions.

Where is the study run from?
Plenamente Comprehensive Mental Health IPS (Colombia)

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

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
1. María Alexandra Cardona Tangarife, macardonat30829@umanizales.edu.co, alexacardonatangarife@gmail.com
2. Daniel Alfredo Landinez 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 logoORCID 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 logoORCID ID 0000-0002-7265-5052
Phone +57 (0)3102305063
Email dlandinez@umanizales.edu.co

Study information

Study designRandomized blinded longitudinal experimental clinical trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleEffect 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
Study acronymECAM-TNL
Study objectivesH0: 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) studiedMild cognitive impairment
InterventionThe 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 typeBehavioural
Primary outcome measure1. 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
Secondary outcome measuresSeverity of anxiety symptoms measured using the Beck Anxiety Inventory (BAI) at baseline and post-intervention
Overall study start date01/07/2024
Completion date30/03/2025

Eligibility

Participant type(s)Patient
Age groupSenior
Lower age limit50 Years
Upper age limit79 Years
SexBoth
Target number of participants100
Key inclusion criteria1. 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 criteria1. 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 enrolment09/08/2024
Date of final enrolment31/12/2024

Locations

Countries of recruitment

  • Colombia

Study participating centre

Plenamente salud mental integral IPS
-Calle 65 # 23B - 79, Av Lindsay
Manizales - Caldas
170001
Colombia

Sponsor information

Universidad de Manizales
University/education

Cra 9 a # 19-03
Manizales
170001
Colombia

Phone +57 (0)887 96 80
Email doctoradopsicologia@umanizales.edu.co
Website https://umanizales.edu.co/
ROR logo "ROR" https://ror.org/031n6w191

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/07/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryPublished as a supplement to the results publication
Publication and dissemination planPublication planned in a peer-reviewed journal
IPD sharing planThe datasets generated and/or analyzed during the current study will be available as a supplement to the publication of the results

Editorial Notes

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.