An interventional study of Cognitive stimulation program in Telerehabilitation, Neuropsychology and HIV Dementia, sponsored by Universidad Nacional Autonoma de Mexico. Withdrawn at 1 site in Mexico. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Universidad Nacional Autonoma de Mexico · Not applicable, Interventional, and Supportive care
Currently 37.9 million people are living with human immunodeficiency virus (HIV) around the world (UNAIDS, 2018). Even with antiretroviral treatment (ART), the virus enters the central nervous system and can affect the following structures: amygdala, hippocampus, thalamus, parietal, frontal, temporal regions, orbitofrontal, cingulate, motor and sensory cortex; generating cognitive, behavioral and motor alterations, up to HIV-associated neurocognitive disorder (HAND) and occasionally HIV-associated dementia (HAD).
Few clinical studies have been conducted using computerized cognitive rehabilitation programs to counteract neuropsychological alterations. The aim of this project is to explore the feasibility of a cognitive stimulation program (CSP) developed to strengthen cognitive domains identified as impaired through a neuropsychological assessment in asymptomatic HIV+ patients adherent to ART, with the purpose of improving their quality of life and mood disorder.
A pilot randomized controlled trial (RCT) will be conducted with a study group and a control group in waiting list. This design will be used because it allows to evaluate the feasibility of a teleneuropsychological intervention (N\&C NeuroChange) and to identify a preliminary effect as a first approach in a given population, provides greater experimental control over the study variables and allows pre-intervention, post-intervention and follow-up comparisons.
Lancaster et al. (2004) state that n=30 is acceptable for a pilot study, while (Julious, 2005) suggest a minimum sample of n=12 per group. Therefore, 24 participants will be recruited for this study. This has already been implemented in other pilot studies that sought to identify the efficacy of an intervention using samples of 20 (Berrymam et al., 2020) and 13 participants (Delaney, 2018) in total. Although the size of the sample may be a methodological limitation, it will be considered in the discussion of the results; in addition to being a preliminary study to carry out a more rigorous study with an RCT. Participants will be eligible if they are between 20 and 45 years old because 77.5% of the reported cases are in this age range in Mexico (CENSIDA, 2022) .
The procedure will be as follows: All participants will be explained what the study consists of, the intervention and will be given informed consent. Patients will be recruited from the Specialized Clinic Condesa Iztapalapa that serves people living with HIV. A brief medical history will begin with an interview to collect medical history (HIV pathological and infectious history such as time of evolution, viral load, CD4 level, ART regimen, as well as substance abuse and cognitive complaints) and then a neuropsychological assessment will be performed. With those candidates who meet the inclusion criteria and wish to participate, will be randomly assigned in a 1:1 ratio to the intervention group or waiting list control arm. The intervention will begin first with the study group, and a subsequent evaluation will be carried out and then the intervention will be applied to the control group on the waiting list, which will also undergo a subsequent evaluation. Both groups will undergo a third follow-up evaluation three months later to identify whether the changes were maintained over time. Main outcomes of interest include evaluation of the achievement of intervention objectives, usability and acceptability of the CSP. Baseline and follow up measures include assessment of attention, memory, visuospatial skills, working memory, processing speed, verbal fluency, planning, abstraction, depressive and anxiety symptomatology, and daily functionality.
41 studies on the registry are indexed under AIDS Dementia Complex; 2 are open to participants now.
Browse AIDS Dementia Complex studies →Universidad Nacional Autonoma de Mexico is the lead sponsor of 28 studies on the registry; 9 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Refers to the experimental group that will receive the cognitive stimulation program intervention.
Behavioral: Cognitive stimulation program
Will be the control group that remains without intervention until the study group completes the cognitive stimulation program and the subsequent neuropsychological assessment has been done. Once the intervention is completed with the study group, the same program will be applied to the control group.
Behavioral: Cognitive stimulation program
The cognitive stimulation program consists of 12 sessions of approximately 45 minutes, distributed in a first stage of training and psychoeducation (1 session), a second stage to address emotional aspects of anxiety and depression (2 sessions), and neuropsychological training (8 sessions) and a final closing stage with one session. There will be two sessions per week for 6 weeks. The neuropsychological training includes 20 activities whose level of difficulty will vary according to the number of stimuli and the time of stimuli presentation. It includes 5 attentional activities, 3 memory activities, 5 executive functioning activities, one visuospatial skills activity and 6 ecological activities. These activities will be developed on a digital computer platform where patients will be assigned an identification and password to ensure confidentiality.
Also known as: N&C NeuroChange
Attention
Direct digits of the Integrated Neuropsychological Exploration Program. The repetition of a series of digits is requested and an element is added as the task progresses. Uses percentile scores.
Time frame: Baseline
Memory
Immediate and deferred texts, and word learning of the Integrated Neuropsychological Exploration Program. Two stories are read and at the end of each one, the patient is asked to narrate everything he/she remembers from the story. In case of not remembering elements, questions are asked about the missing information. The stories are asked again after 5 minutes. Uses percentile scores.
Time frame: Baseline
Visuospatial skills
Rey Figure of the NEUROPSI A\&M. A complex figure is copied from a model. Afterwards, the figure is drawn again without the model. Uses scalar scores.
Time frame: Baseline
Working memory
Digits and letters of the Weschler Adults Intelligence Scale IV. Numbers and letters are provided in disorder and all the elements are asked to be repeated in order, first the numbers and then the letters. Uses scalar scores.
Time frame: Baseline
Processing speed
Word reading of Stroop test. A list of 5 columns of words with 20 items each is read as quickly as possible. Uses percentile scores.
Time frame: Baseline
Verbal fluency
Categorical recall of the Integrated Neuropsychological Exploration Program. The highest number of animals is said in one minute and the highest number of words beginning with "p" in three minutes. Uses percentile scores.
Time frame: Baseline
Planning
Zoo test of the Behavioral Assessment of Dysexecutive Syndrome and Behavioral Rating Inventory of Executive Functioning for Adults. Consists in marking a route in a zoo map to visit different places. Afterwards, the person marks again in the zoo map a rout but is told which route to follow.
Time frame: Baseline
Abstraction
Resemblances of the Weschler Adults Intelligence Scale IV. Consists in mentioning what two words have in common or how they are similar. Uses scalar scores.
Time frame: Baseline
Attention
Direct digits of the Integrated Neuropsychological Exploration Program. The repetition of a series of digits is requested and an element is added as the task progresses. Uses percentile scores.
Time frame: Immediately after the intervention
Memory
Immediate and deferred texts, and word learning of the Integrated Neuropsychological Exploration Program. Two stories are read and at the end of each one, the patient is asked to narrate everything he/she remembers from the story. In case of not remembering elements, questions are asked about the missing information. The stories are asked again after 5 minutes. Uses percentile scores.
Time frame: Immediately after the intervention
Visuospatial skills
Rey Figure of the NEUROPSI A\&M. A complex figure is copied from a model. Afterwards, the figure is drawn again without the model. Uses scalar scores.
Time frame: Immediately after the intervention
Working memory
Digits and letters of the Weschler Adults Intelligence Scale IV. Numbers and letters are provided in disorder and all the elements are asked to be repeated in order, first the numbers and then the letters. Uses scalar scores.
Time frame: Immediately after the intervention
Processing speed
Word reading of Stroop test. A list of 5 columns of words with 20 items each is read as quickly as possible. Uses percentile scores.
Time frame: Immediately after the intervention
Verbal fluency
Categorical recall of the Integrated Neuropsychological Exploration Program. The highest number of animals is said in one minute and the highest number of words beginning with "p" in three minutes. Uses percentile scores.
Time frame: Immediately after the intervention
Planning
Zoo test of the Behavioral Assessment of Dysexecutive Syndrome and Behavioral Rating Inventory of Executive Functioning for Adults. Consists in marking a route in a zoo map to visit different places. Afterwards, the person marks again in the zoo map a rout but is told which route to follow.
Time frame: Immediately after the intervention
Abstraction
Resemblances of the Weschler Adults Intelligence Scale IV. Consists in mentioning what two words have in common or how they are similar. Uses scalar scores.
Time frame: Immediately after the intervention
Attention
Direct digits of the Integrated Neuropsychological Exploration Program. The repetition of a series of digits is requested and an element is added as the task progresses. Uses percentile scores.
Time frame: Up to 12 weeks
Memory
Immediate and deferred texts, and word learning of the Integrated Neuropsychological Exploration Program. Two stories are read and at the end of each one, the patient is asked to narrate everything he/she remembers from the story. In case of not remembering elements, questions are asked about the missing information. The stories are asked again after 5 minutes. Uses percentile scores.
Time frame: Up to 12 weeks
Visuospatial skills
Rey Figure of the NEUROPSI A\&M. A complex figure is copied from a model. Afterwards, the figure is drawn again without the model. Uses scalar scores.
Time frame: Up to 12 weeks
Working memory
Digits and letters of the Weschler Adults Intelligence Scale IV. Numbers and letters are provided in disorder and all the elements are asked to be repeated in order, first the numbers and then the letters. Uses scalar scores.
Time frame: Up to 12 weeks
Processing speed
Word reading of Stroop test. A list of 5 columns of words with 20 items each is read as quickly as possible. Uses percentile scores.
Time frame: Up to 12 weeks
Verbal fluency
Categorical recall of the Integrated Neuropsychological Exploration Program. The highest number of animals is said in one minute and the highest number of words beginning with "p" in three minutes. Uses percentile scores.
Time frame: Up to 12 weeks
Planning
Zoo test of the Behavioral Assessment of Dysexecutive Syndrome and Behavioral Rating Inventory of Executive Functioning for Adults. Consists in marking a route in a zoo map to visit different places. Afterwards, the person marks again in the zoo map a rout but is told which route to follow.
Time frame: Up to 12 weeks
Abstraction
Resemblances of the Weschler Adults Intelligence Scale IV. Consists in mentioning what two words have in common or how they are similar. Uses scalar scores.
Time frame: Up to 12 weeks
Depressive Symptoms
Patient Health Questionnaire - 9. A self-applied questionnaire that identifies the presence of depressive symptomatology based on a Likert-type scale of 9 items. Based on the cut-off points, minimal (0-4), mild (5-9), moderate (10-14), moderate to severe (15-19) and severe (20-27) depression can be identified.
Time frame: Baseline
Anxiety symptoms
General Anxiety Disorder - 7. A self-applied scale to identify generalized anxiety. It consists of a self-applied questionnaire of seven Likert-type questions. Based on the cut-off points, no anxiety (0-4), mild anxiety symptoms (5-9), moderate anxiety symptoms (10-14) and severe anxiety symptoms (15-21) can be identified.
Time frame: Baseline
Daily functionality
The Activities of Daily Living Questionnaire. This instrument evaluates daily functioning by assessing basic and instrumental activities in six areas (self-care, home activities, work, recreation, money management, travel and communication, and information technology); it is usually useful for patients with mild cognitive or motor limitations. It allows to generate a percentage of functional impairment by adding the scores of each item among the total number of responses per 100.
Time frame: Baseline
Depressive Symptoms
Patient Health Questionnaire - 9. A self-applied questionnaire that identifies the presence of depressive symptomatology based on a Likert-type scale of 9 items. Based on the cut-off points, minimal (0-4), mild (5-9), moderate (10-14), moderate to severe (15-19) and severe (20-27) depression can be identified.
Time frame: Immediately after the intervention
Anxiety symptoms
General Anxiety Disorder - 7. A self-applied scale to identify generalized anxiety. It consists of a self-applied questionnaire of seven Likert-type questions. Based on the cut-off points, no anxiety (0-4), mild anxiety symptoms (5-9), moderate anxiety symptoms (10-14) and severe anxiety symptoms (15-21) can be identified.
Time frame: Immediately after the intervention
Daily functionality
The Activities of Daily Living Questionnaire. This instrument evaluates daily functioning by assessing basic and instrumental activities in six areas (self-care, home activities, work, recreation, money management, travel and communication, and information technology); it is usually useful for patients with mild cognitive or motor limitations. It allows to generate a percentage of functional impairment by adding the scores of each item among the total number of responses per 100.
Time frame: Immediately after the intervention
Depressive Symptoms
Patient Health Questionnaire - 9. A self-applied questionnaire that identifies the presence of depressive symptomatology based on a Likert-type scale of 9 items. Based on the cut-off points, minimal (0-4), mild (5-9), moderate (10-14), moderate to severe (15-19) and severe (20-27) depression can be identified.
Time frame: Up to 12 weeks
Anxiety symptoms
General Anxiety Disorder - 7. A self-applied scale to identify generalized anxiety. It consists of a self-applied questionnaire of seven Likert-type questions. Based on the cut-off points, no anxiety (0-4), mild anxiety symptoms (5-9), moderate anxiety symptoms (10-14) and severe anxiety symptoms (15-21) can be identified.
Time frame: Up to 12 weeks
Daily functionality
The Activities of Daily Living Questionnaire. This instrument evaluates daily functioning by assessing basic and instrumental activities in six areas (self-care, home activities, work, recreation, money management, travel and communication, and information technology); it is usually useful for patients with mild cognitive or motor limitations. It allows to generate a percentage of functional impairment by adding the scores of each item among the total number of responses per 100.
Time frame: Up to 12 weeks
Evaluation of the achievement of intervention objectives
Goal Assessment Scale. Mathematical technique that identifies the achievement of objectives in a rehabilitation program based on the perception of the patient and/or family member. Each objective is measured on a 5-point scale ranging from -2 to +2 (very little, little, expected level, more than expected, much more than expected).
Time frame: Baseline
Evaluation of the usability of the cognitive stimulation program
System usability scale. A 5-level Likert-type scale (strongly disagree to strongly agree) that evaluates the opinion of the participants regarding the usability of digital systems. A maximum total score of 100 is obtained by averaging each response from all questionnaires.
Time frame: Immediately after the intervention
Evaluation of the acceptability of the cognitive stimulation program
In the last session of the intervention, a qualitative interview will be conducted with the participants. The interview will include questions associated with the relevance, usefulness, acceptability and satisfaction of the cognitive stimulation program.
Time frame: Immediately after the intervention
Evaluation of the achievement of intervention objectives
Goal Assessment Scale. Mathematical technique that identifies the achievement of objectives in a rehabilitation program based on the perception of the patient and/or family member. Each objective is measured on a 5-point scale ranging from -2 to +2 (very little, little, expected level, more than expected, much more than expected).
Time frame: Immediately after the intervention
Plan to share: No — While the results of the present research will be shared in a scientific publication article, there is still no plan to make IPDs available due to the confidentiality that must be maintained when working with HIV+ populations and the ethical issues that remain during the research.
Ran from May 2022 to primary completion in Nov 2023, 18 months.
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Universidad Nacional Autonoma de Mexico