Clinical trial NCT05571761: Teleneuropsychological Intervention in Asymptomatic HIV Seropositive Patients: N&C NeuroChange
Official title: Feasibility and Usefulness of a Neuropsychological Telerehabilitation Program in Asymptomatic HIV Patients: Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Telerehabilitation
Neuropsychology
HIV Dementia
Keywords: HIV
HAND
Teleneuropsychological intervention
Lead sponsor: Universidad Nacional Autonoma de Mexico
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Attention
timeFrame: Baseline
measure: Memory
timeFrame: Baseline
measure: Visuospatial skills
timeFrame: Baseline
measure: Working memory
timeFrame: Baseline
measure: Processing speed
timeFrame: Baseline
measure: Verbal fluency
timeFrame: Baseline
measure: Planning
timeFrame: Baseline
measure: Abstraction
timeFrame: Baseline
measure: Attention
timeFrame: Immediately after the intervention
measure: Memory
timeFrame: Immediately after the intervention
measure: Visuospatial skills
timeFrame: Immediately after the intervention
measure: Working memory
timeFrame: Immediately after the intervention
measure: Processing speed
timeFrame: Immediately after the intervention
measure: Verbal fluency
timeFrame: Immediately after the intervention
measure: Planning
timeFrame: Immediately after the intervention
measure: Abstraction
timeFrame: Immediately after the intervention
measure: Attention
timeFrame: Up to 12 weeks
measure: Memory
timeFrame: Up to 12 weeks
measure: Visuospatial skills
timeFrame: Up to 12 weeks
measure: Working memory
timeFrame: Up to 12 weeks
measure: Processing speed
timeFrame: Up to 12 weeks
measure: Verbal fluency
timeFrame: Up to 12 weeks
measure: Planning
timeFrame: Up to 12 weeks
measure: Abstraction
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: Baseline
measure: Anxiety symptoms
timeFrame: Baseline
measure: Daily functionality
timeFrame: Baseline
measure: Depressive Symptoms
timeFrame: Immediately after the intervention
measure: Anxiety symptoms
timeFrame: Immediately after the intervention
measure: Daily functionality
timeFrame: Immediately after the intervention
measure: Depressive Symptoms
timeFrame: Up to 12 weeks
measure: Anxiety symptoms
timeFrame: Up to 12 weeks
measure: Daily functionality
timeFrame: Up to 12 weeks
Other outcomes:
measure: Evaluation of the achievement of intervention objectives
timeFrame: Baseline
measure: Evaluation of the usability of the cognitive stimulation program
timeFrame: Immediately after the intervention
measure: Evaluation of the acceptability of the cognitive stimulation program
timeFrame: Immediately after the intervention
measure: Evaluation of the achievement of intervention objectives
timeFrame: Immediately after the intervention
Locations:
city: Mexico City
country: Mexico
facility: Condesa Iztapalapa Specialized Clinic
state: Iztapalapa
Study officials:
affiliation: Universidad Nacional Autonoma de Mexico
name: Natalia C Cortés, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Nacional Autonoma de Mexico
name: Ma Guillermina T Yáñez, PhD
role: STUDY_CHAIR
affiliation: Universidad Nacional Autonoma de Mexico
name: Dulce María Bélen C Prieto, PhD
role: STUDY_CHAIR
affiliation: Universidad Nacional Autonoma de Mexico
name: Edgar R Landa, PhD
role: STUDY_CHAIR
affiliation: National Polythecnic Institute
name: Juan C Castillo, PhD
role: STUDY_CHAIR
References:
citation: 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.
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.
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.
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.
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.
citation: 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.
citation: Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005; 4: 287e91.
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.
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.