Clinical trial NCT06699927: Working Memory Training for People Aging with HIV
Official title: A Feasibility Study of Working Memory Training for People Aging with HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Cognitive Change
Lead sponsor: Northeastern University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized crossover trial will be conducted and participants will be randomly assigned to 1 of 2 conditions: Condition 1 consists of training type 1 followed by training type 2, whereas Condition 2 consists of training type 2 followed by training type 1. They will be assigned to Non-Gamified Span training and Gamified Span training.
Primary purpose: BASIC_SCIENCE

Brief summary: The present study investigates the feasibility of working memory training in people aging with HIV (PAWHIV). In a cross-over design this stage 1 feasibility trial, will evaluate acceptability, and estimate possible effect sizes related to working memory training by examining potential differential effects in PAWHIV and those aging without HIV. This project highlights the importance of tailored cognitive assessments and interventions, engaging with underrepresented communities to enhance inclusivity in cognitive health research.

Detailed description: In a randomized controlled trial (RCT) with a 3x2 design (pre-test, post-test, follow-up; PAWHIV, people aging without HIV), we will evaluate feasibility of implementing working memory-based interventions in PAWHIV. This study will examine the differential effects of WM training between PAWHIV and aging adults without HIV, providing insight into specific cognitive challenges in PAWHIV that may influence the efficacy of cognitive training interventions. The results of this trial will be instrumental in developing targeted, evidence-based interventions that promote cognitive health for PAWHIV and contribute to the broader understanding of cognitive aging in vulnerable populations.

Relying on an extended battery of cognitive assessments, we will test different multivariate models to best capture the unique cognitive profiles of PAWHIV and how they compare with people aging without HIV. This analytical framework will allow us to gain insight into and better addressing the needs of the PAWHIV community

The cross-over trial will obtain within-subject comparisons of training with enriched (game-like) versions of working memory training tasks compared to basic (non-gamified) versions of these tasks. Participants are assigned to Non-Gamified Span training and Gamified Span training for a total of 50 sessions per participant: the first few sessions consist of completing questionnaires and computerized cognitive assessments (pre-test). Participants then complete 20 sessions of working memory training. After a mid-test, they complete 20 sessions of a different type of working memory training. Post-test is administered upon training completion, and at least a month later, participants complete 3 follow-up sessions.

Eligibility criteria: Inclusion Criteria:

* 50-85 years of age
* Able to understand and speak English and follow study procedures
* Does not have a psychological or neurological condition that would prevent being able to give consent to participate
* Not currently involved in any other cognitive or memory training studies

Exclusion Criteria:

* Formal diagnosis of dementia or other neurological disease, including Mild cognitive impairment.
* A final total score below 17 on Montreal Cognitive Assessment - Blind (telephone) version.
* Score of 10 or more on the Generalized Anxiety Questionnaire (GAD7; Spitzer et al., 2006, Archives of Internal Medicine), indicating presence of moderate or severe anxiety
* Score of 9 or more on Geriatric depression scale (GDS15; Yesavage et al., 1982) indicating presence of moderate or severe depression
* Abnormal visual acuity prohibitive of tablet-based training.
* Physical handicap (motor or perceptual) that would impede training procedures.
* Medical illness requiring treatment and/or significant absences during the study timeline.
* Current evidence or 2-yr history of seizures, focal brain lesion, or head injury with loss of consciousness.
* Current alcohol consumption exceeds 14 drinks per week.
* Self-reported illicit drug use.

Primary outcomes:
measure: Change in Everyday Memory Questionnaire Revised
timeFrame: Day 24, Day 46, Day 77
measure: Change in General Cognitive Ability Composite Score
timeFrame: Day 77
Secondary outcomes:
measure: Change in Inhibitory Control Composite Score
timeFrame: Day 24, Day 46, Day 78
measure: Training Experience Enjoyment
timeFrame: Day 24, Day 46
measure: Training Experience Subjective Progress
timeFrame: Day 24, Day 46
measure: Training Experience Satisfaction Scale
timeFrame: Day 24, Day 46
measure: Training Experience Difficulty Scale
timeFrame: Day 24, Day 46
measure: Exit Survey
timeFrame: Time Frame: Day 79
Other outcomes:
Locations:
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
Study officials:
affiliation: Northeastern University
name: Susanne Jaeggi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northeastern University
name: Aaron Seitz
role: PRINCIPAL_INVESTIGATOR
References: