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

NCT05571761 | Withdrawn

• 1 other identifier: TNSP
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Telerehabilitation; Neuropsychology; HIV Dementia

Keywords

HIV; HAND; Teleneuropsychological intervention

Outcome Measures

Primary Outcomes (24)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (9)

• Depressive Symptoms

  Baseline

• Anxiety symptoms

  Baseline

• Daily functionality

  Baseline

• Depressive Symptoms

  Immediately after the intervention

• Anxiety symptoms

  Immediately after the intervention

Other Outcomes (4)

• Evaluation of the achievement of intervention objectives

  Baseline

• Evaluation of the usability of the cognitive stimulation program

  Immediately after the intervention

• Evaluation of the acceptability of the cognitive stimulation program

  Immediately after the intervention

Study Arms (2)

Study group

EXPERIMENTAL

Refers to the experimental group that will receive the cognitive stimulation program intervention.

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.

Behavioral: Cognitive stimulation program

Interventions

Cognitive stimulation program BEHAVIORAL

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

Study group; Waiting list control group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or females with HIV
• Minimum primary education
• From 20 to 45 years old
• Normal or corrected vision and hearing
• Treatment adherence

You may not qualify if:

• Neurological and psychiatric history (except mood disorders)
• Head injuries
• Cerebrovascular events
• Substance abuse
• AIDS associated diseases
• Hormonal therapy

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead

Study Sites (1)

Condesa Iztapalapa Specialized Clinic

Mexico City, Iztapalapa, 09730, Mexico

Location

Related 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.

  PMID: 22458375 BACKGROUND

• 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.

  PMID: 32673163 BACKGROUND

• 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.

  PMID: 20804255 BACKGROUND

• 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.

  PMID: 22579081 BACKGROUND

• 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.

  PMID: 23417497 BACKGROUND

• 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.

  PMID: 15189396 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 32078510 BACKGROUND

• 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.

  PMID: 30462717 BACKGROUND

Related 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.

MeSH Terms

Conditions

AIDS Dementia Complex

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Natalia C Cortés, MD

  Universidad Nacional Autonoma de Mexico

  PRINCIPAL INVESTIGATOR

• Ma Guillermina T Yáñez, PhD

  Universidad Nacional Autonoma de Mexico

  STUDY CHAIR

• Dulce María Bélen C Prieto, PhD

  Universidad Nacional Autonoma de Mexico

  STUDY CHAIR

• Edgar R Landa, PhD

  Universidad Nacional Autonoma de Mexico

  STUDY CHAIR

• Juan C Castillo, PhD

  National Polythecnic Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Random assignment will not be disclosed to the participants. The participants in the intervention arm will be contacted first, and once this is completed, the participants in the waiting list control arm will be contacted for the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 7, 2022
• Study Start: May 16, 2022
• Primary Completion: November 28, 2023
• Study Completion: May 30, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)