TelerehabilitationNCT05571761
Teleneuropsychological Intervention in Asymptomatic HIV Seropositive Patients: N&C NeuroChange
A study testing Cognitive stimulation program in people with Telerehabilitation and Neuropsychology, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Telerehabilitation, Neuropsychology, HIV Dementia
- What is being tested?
- Cognitive stimulation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- 16 May 2022to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or females with HIV
- Minimum primary education
- From 20 to 45 years old
- Normal or corrected vision and hearing
- Treatment adherence
Who cannot join
- Neurological and psychiatric history (except mood disorders)
- Head injuries
- Cerebrovascular events
- Substance abuse
- AIDS associated diseases
- Hormonal therapy
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Condesa Iztapalapa Specialized Clinic
Mexico City, Iztapalapa, 09730
About this study
Official title: Feasibility and Usefulness of a Neuropsychological Telerehabilitation Program in Asymptomatic HIV Patients: Pilot Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Telerehabilitation, Neuropsychology, HIV Dementia
- Being tested
- Cognitive stimulation program
- Keywords
- HIV, HAND, Teleneuropsychological intervention
- Medical subject headings
- AIDS Dementia Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive stimulation programBehavioural
Also called N&C NeuroChange
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Refers to the experimental group that will receive the cognitive stimulation program intervention. Receives: Behavioral: Cognitive stimulation program |
| Waiting list control group | Other | 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. Receives: Behavioral: Cognitive stimulation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start16 May 2022
- Primary completion28 Nov 2023
- Study completion30 May 2024
Why it stopped: experimental abandonment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for TelerehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pilot randomized clinical trial will be conducted with HIV+ participants randomised in a 1:1 ratio to a study group that will receive the neuropsychological intervention and a second control group that will remain waiting until the study group finishes the intervention and after that can receive the intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalia Cortés Corona, MD, Universidad Nacional Autonoma de Mexico
- Investigators
- Natalia C Cortés, MD, Principal investigator, Universidad Nacional Autonoma de MexicoMa Guillermina T Yáñez, PhD, Study chair, Universidad Nacional Autonoma de MexicoDulce María Bélen C Prieto, PhD, Study chair, Universidad Nacional Autonoma de MexicoEdgar R Landa, PhD, Study chair, Universidad Nacional Autonoma de MexicoJuan C Castillo, PhD, Study chair, National Polythecnic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571761
- Sponsor's protocol ID
- TNSP
- Status last verified
- Jun 2024
- First submitted
- 27 Sep 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Becker JT, Dew MA, Aizenstein HJ, Lopez OL, Morrow L, Saxton J, Tarraga L. A pilot study of the effects of internet-based cognitive stimulation on neuropsychological function in HIV disease. Disabil Rehabil. 2012;34(21):1848-52. doi: 10.3109/09638288.2012.667188. Epub 2012 Mar 30.
PubMed 22458375Bilder RM, Postal KS, Barisa M, Aase DM, Cullum CM, Gillaspy SR, Harder L, Kanter G, Lanca M, Lechuga DM, Morgan JM, Most R, Puente AE, Salinas CM, Woodhouse J. InterOrganizational practice committee recommendations/guidance for teleneuropsychology (TeleNP) in response to the COVID-19 pandemic. Clin Neuropsychol. 2020 Oct-Nov;34(7-8):1314-1334. doi: 10.1080/13854046.2020.1767214. Epub 2020 Jul 16.
PubMed 32673163Boivin MJ, Busman RA, Parikh SM, Bangirana P, Page CF, Opoka RO, Giordani B. A pilot study of the neuropsychological benefits of computerized cognitive rehabilitation in Ugandan children with HIV. Neuropsychology. 2010 Sep;24(5):667-73. doi: 10.1037/a0019312.
PubMed 20804255Vance DE, Fazeli PL, Ross LA, Wadley VG, Ball KK. Speed of processing training with middle-age and older adults with HIV: a pilot study. J Assoc Nurses AIDS Care. 2012 Nov-Dec;23(6):500-10. doi: 10.1016/j.jana.2012.01.005. Epub 2012 May 11.
PubMed 22579081Weber E, Blackstone K, Woods SP. Cognitive neurorehabilitation of HIV-associated neurocognitive disorders: a qualitative review and call to action. Neuropsychol Rev. 2013 Mar;23(1):81-98. doi: 10.1007/s11065-013-9225-6. Epub 2013 Feb 16.
PubMed 23417497Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
PubMed 15189396Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005; 4: 287e91.
Berryman A, Rasavage K, Politzer T, Gerber D. Oculomotor Treatment in Traumatic Brain Injury Rehabilitation: A Randomized Controlled Pilot Trial. Am J Occup Ther. 2020 Jan/Feb;74(1):7401185050p1-7401185050p7. doi: 10.5014/ajot.2020.026880.
PubMed 32078510Delaney MC. Caring for the caregivers: Evaluation of the effect of an eight-week pilot mindful self-compassion (MSC) training program on nurses' compassion fatigue and resilience. PLoS One. 2018 Nov 21;13(11):e0207261. doi: 10.1371/journal.pone.0207261. eCollection 2018.
PubMed 30462717
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Usefulness of a Neuropsychological Telerehabilitation Program in Asymptomatic HIV Patients: Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05571761
- Acronym / sponsor ID
- TNSP
- Conditions
- Telerehabilitation, Neuropsychology, HIV Dementia
- Keywords
- HIV, HAND, Teleneuropsychological intervention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: experimental abandonment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidad Nacional Autonoma de MexicoUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A pilot randomized clinical trial will be conducted with HIV+ participants randomised in a 1:1 ratio to a study group that will receive the neuropsychological intervention and a second control group that will remain waiting until the study group finishes the intervention and after that can receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: Cognitive stimulation programRefers to the experimental group that will receive the cognitive stimulation program intervention. |
| Waiting list control group | Other | Behavioral: Cognitive stimulation programWill 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or females with HIV
- Minimum primary education
- From 20 to 45 years old
- Normal or corrected vision and hearing
- Treatment adherence
Key exclusion criteria (6 listed)
- Neurological and psychiatric history (except mood disorders)
- Head injuries
- Cerebrovascular events
- Substance abuse
- AIDS associated diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive stimulation programAlso: N&C NeuroChangeThe 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. | Behavioural | Study group, Waiting list control group |
Primary outcome
Attention
Time frame: Baseline
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.
Memory
Time frame: Baseline
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.
Visuospatial skills
Time frame: Baseline
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.
Working memory
Time frame: Baseline
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.
Processing speed
Time frame: Baseline
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.
Verbal fluency
Time frame: Baseline
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.
Planning
Time frame: Baseline
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.
Abstraction
Time frame: Baseline
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.
Attention
Time frame: Immediately after the intervention
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.
Memory
Time frame: Immediately after the intervention
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.
Visuospatial skills
Time frame: Immediately after the intervention
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.
Working memory
Time frame: Immediately after the intervention
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.
Processing speed
Time frame: Immediately after the intervention
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.
Verbal fluency
Time frame: Immediately after the intervention
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.
Planning
Time frame: Immediately after the intervention
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.
Abstraction
Time frame: Immediately after the intervention
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.
Attention
Time frame: Up to 12 weeks
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.
Memory
Time frame: Up to 12 weeks
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.
Visuospatial skills
Time frame: Up to 12 weeks
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.
Working memory
Time frame: Up to 12 weeks
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.
Processing speed
Time frame: Up to 12 weeks
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.
Verbal fluency
Time frame: Up to 12 weeks
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.
Planning
Time frame: Up to 12 weeks
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.
Abstraction
Time frame: Up to 12 weeks
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.
9 secondary outcomes
Depressive Symptoms
Time frame: Baseline
Anxiety symptoms
Time frame: Baseline
Daily functionality
Time frame: Baseline
Depressive Symptoms
Time frame: Immediately after the intervention
Anxiety symptoms
Time frame: Immediately after the intervention
Daily functionality
Time frame: Immediately after the intervention
Depressive Symptoms
Time frame: Up to 12 weeks
Anxiety symptoms
Time frame: Up to 12 weeks
Daily functionality
Time frame: Up to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 22458375Becker JT, Dew MA, Aizenstein HJ, Lopez OL, Morrow L, Saxton J, Tarraga L. A pilot study of the effects of internet-based cognitive stimulation on neuropsychological function in HIV disease. Disabil Rehabil. 2012;34(21):1848-52. doi: 10.3109/09638288.2012.667188. Epub 2012 Mar 30.
- Background: PubMed 32673163Bilder RM, Postal KS, Barisa M, Aase DM, Cullum CM, Gillaspy SR, Harder L, Kanter G, Lanca M, Lechuga DM, Morgan JM, Most R, Puente AE, Salinas CM, Woodhouse J. InterOrganizational practice committee recommendations/guidance for teleneuropsychology (TeleNP) in response to the COVID-19 pandemic. Clin Neuropsychol. 2020 Oct-Nov;34(7-8):1314-1334. doi: 10.1080/13854046.2020.1767214. Epub 2020 Jul 16.
- Background: PubMed 20804255Boivin MJ, Busman RA, Parikh SM, Bangirana P, Page CF, Opoka RO, Giordani B. A pilot study of the neuropsychological benefits of computerized cognitive rehabilitation in Ugandan children with HIV. Neuropsychology. 2010 Sep;24(5):667-73. doi: 10.1037/a0019312.
- Background: PubMed 22579081Vance DE, Fazeli PL, Ross LA, Wadley VG, Ball KK. Speed of processing training with middle-age and older adults with HIV: a pilot study. J Assoc Nurses AIDS Care. 2012 Nov-Dec;23(6):500-10. doi: 10.1016/j.jana.2012.01.005. Epub 2012 May 11.
- Background: PubMed 23417497Weber E, Blackstone K, Woods SP. Cognitive neurorehabilitation of HIV-associated neurocognitive disorders: a qualitative review and call to action. Neuropsychol Rev. 2013 Mar;23(1):81-98. doi: 10.1007/s11065-013-9225-6. Epub 2013 Feb 16.
- Background: PubMed 15189396Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
- BackgroundJulious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005; 4: 287e91.
- Background: PubMed 32078510Berryman A, Rasavage K, Politzer T, Gerber D. Oculomotor Treatment in Traumatic Brain Injury Rehabilitation: A Randomized Controlled Pilot Trial. Am J Occup Ther. 2020 Jan/Feb;74(1):7401185050p1-7401185050p7. doi: 10.5014/ajot.2020.026880.
- Background: PubMed 30462717Delaney MC. Caring for the caregivers: Evaluation of the effect of an eight-week pilot mindful self-compassion (MSC) training program on nurses' compassion fatigue and resilience. PLoS One. 2018 Nov 21;13(11):e0207261. doi: 10.1371/journal.pone.0207261. eCollection 2018.
- Joint United Nations Programme on HIV/AIDS (UNAIDS) (2018). Global AIDS update 2019.Link provided by the sponsor.
- National Center for Prevention and Control of HIV and AIDS (CENSIDA) (2022). Epidemiological Surveillance of HIV/AIDS Cases in Mexico, Update for the 1st Quarter of 2022.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia C Cortés, MD principal investigator
Universidad Nacional Autonoma de Mexico
Ma Guillermina T Yáñez, PhD study chair
Universidad Nacional Autonoma de Mexico
Dulce María Bélen C Prieto, PhD study chair
Universidad Nacional Autonoma de Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive stimulation program in people with Telerehabilitation and Neuropsychology, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention (time frame: Baseline). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05571761, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.