Teleneuropsychological Intervention in Asymptomatic HIV Seropositive Patients: N&C NeuroChange

Telerehabilitation Clinical Trial

Official title:

Feasibility and Usefulness of a Neuropsychological Telerehabilitation Program in Asymptomatic HIV Patients: Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05571761
• Other study ID #: TNSP
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2023
• Source: Universidad Nacional Autonoma de Mexico
• Contact: Natalia C Cortés, MD
• Phone: +52 5529358114
• Email: nat29cc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Male or females with HIV

• Minimum primary education

• From 20 to 45 years old

• Normal or corrected vision and hearing

• Treatment adherence

Exclusion Criteria:

• Neurological and psychiatric history (except mood disorders)

• Head injuries

• Cerebrovascular events

• Substance abuse

• AIDS associated diseases

• Hormonal therapy

Related Conditions & MeSH terms

• AIDS Dementia Complex
• HIV Dementia
• Neuropsychology
• Telerehabilitation

Intervention

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.

Locations

Country	Name	City	State
Mexico	Condesa Iztapalapa Specialized Clinic	Mexico City	Iztapalapa

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional Autonoma de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (9)

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. — View Citation

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. — View Citation

Bilder 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. — View Citation

Boivin 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. — View Citation

Delaney 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. — View Citation

Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005; 4: 287e91.

Lancaster 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. — View Citation

Vance 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. — View Citation

Weber 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	Baseline
Other	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.	Immediately after the intervention
Other	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.	Immediately after the intervention
Other	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).	Immediately after the intervention
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Immediately after the intervention
Primary	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.	Immediately after the intervention
Primary	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.	Immediately after the intervention
Primary	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.	Immediately after the intervention
Primary	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.	Immediately after the intervention
Primary	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.	Immediately after the intervention
Primary	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.	Immediately after the intervention
Primary	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.	Immediately after the intervention
Primary	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.	Up to 12 weeks
Primary	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.	Up to 12 weeks
Primary	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.	Up to 12 weeks
Primary	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.	Up to 12 weeks
Primary	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.	Up to 12 weeks
Primary	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.	Up to 12 weeks
Primary	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.	Up to 12 weeks
Primary	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.	Up to 12 weeks
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Immediately after the intervention
Secondary	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.	Immediately after the intervention
Secondary	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.	Immediately after the intervention
Secondary	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.	Up to 12 weeks
Secondary	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.	Up to 12 weeks
Secondary	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.	Up to 12 weeks

External Links

•   Joint United Nations Programme on HIV/AIDS (UNAIDS) (2018). Global AIDS update 2019.
•   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.