Speed of Processing Training in Adults With HIV

NCT02758093 | Completed DMC

• 1 other identifier: F160122002
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

Brief Summary

As people age with HIV, the synergistic effects with normal age-related cognitive declines will accentuate and/or accelerate declines in cognitive functioning which can be detected as early in one's 40s. Although interventions are needed to protect/improve cognitive functioning, one intervention already exists to improve speed of processing. NINR/NIA (January 14, 2014) announced that Speed of Processing Training used in the ACTIVE Study (N = 2,802 community-dwelling older adults) has the ability to enable "older people to maintain their cognitive abilities as they age" even 10 years after training. As shown in the ACTIVE Study, this intervention uniquely improves driving, instrumental activities of daily living (IADL), health-related quality of life, self-rated health, internal locus of control, and protects one from depression; these represent areas of needed intervention for adults with HIV as well. In adults with HIV, previous pilot studies likewise indicate speed of processing declines are associated with poorer driving simulator performance and more self-reported at-fault automobile crashes; such speed of processing declines on driving alone represent a significant public health concern. These studies also demonstrated that Speed of Processing Training improved this cognitive ability and translated into improved performance on a timed measure of IADLs. Based on prior research, this RCT proposal consists of a pre-post two-year longitudinal experimental design whereby 264 adults with HIV, 40+ years and diagnosed with HIV-Associated Neurocognitive Disorder, will be randomly assigned to one of three training conditions: 1) 10 hours of laboratory-based Speed of Processing Training, 2) 20 hours of laboratory-based Speed of Processing Training, or 3) 10 hours of a standardized computer-contact control (sham) condition. AIM 1: Determine whether 10 vs 20 hours of speed of processing training will improve this cognitive ability at post-test, year 1, and year 2 after baseline. AIM 2: Determine whether 10 vs 20 hours of speed of processing training will improve everyday functioning at post-test, year 1, and year 2 after baseline. Exploratory AIM: Determine whether improvement in speed in speed of processing and/or everyday functioning over time mediate improvement quality of life (e.g., depression, health related quality of life).

Conditions

HIV; Cognition - Other; Impaired Driving

Outcome Measures

Primary Outcomes (4)

• Mean Speed of Processing Measures at baseline

  Cognitive measures of speed of processing (i.e., Useful Field of View) will be used to determine whether the training was effective.

  at baseline

• Mean Speed of Processing Measures at 10 - 12 weeks after baseline

  Cognitive measures of speed of processing (i.e., Useful Field of View) will be used to determine whether the training was effective.

  at 10-12 weeks after baseline

• Mean Speed of Processing Measures at 1 year after baseline

  Cognitive measures of speed of processing (i.e., Useful Field of View) will be used to determine whether the training was effective.

  at 1 year after baseline

• Mean Speed of Processing Measures at 2 years after baseline

  Cognitive measures of speed of processing (i.e., Useful Field of View) will be used to determine whether the training was effective.

  at 2 years after baseline

Secondary Outcomes (7)

• Driving Simulation (a measure of everyday functioning)

  Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline)

• Number of vehicular crashes identified in State Crash Records for the 5 years prior to enrollment

  from baseline to 5 years prior to baseline

• Driving Habits Questionnaire (a measure of everyday functioning)

  from baseline to 5 years prior to baseline

• Timed Instrument Activities of Daily Living (a measure of everyday functioning)

  Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline)

• Medication Adherence (a measure of everyday functioning)

  Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline)

Other Outcomes (4)

• Centers for Epidemiological Studies Depression Scale (a quality of life measure)

  Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline)

• Internal Locus of Control (a quality of life measure)

  Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline)

• Medical Outcomes Study Short Form (a quality of life measure)

  Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline)

Study Arms (3)

Speed of Processing Training (10 hours)

EXPERIMENTAL

Participants randomized to this arm will receive 10 hours of speed of processing training; this training is designed to improve the speed/accuracy in which they identify and locate visual information using five games/exercises from the POSIT Science Speed of Processing Training. Those who receive 20 hours of speed of processing training will be compared to those participants who are randomized only to receive 10 hours speed of processing training; both of these groups will be compared to those randomized to receive only 10 hours of a computer training (Contact Control Group).

Behavioral: Speed of Processing Training

Speed of Processing Training (20 hours)

EXPERIMENTAL

Participants randomized to this arm will receive 20 hours of speed of processing training; this training is designed to improve the speed/accuracy in which they identify and locate visual information using five games/exercises from the POSIT Science Speed of Processing Training. Those who receive 20 hours of speed of processing training will be compared to those participants who are randomized only to receive 10 hours speed of processing training; both of these groups will be compared to those randomized to receive only 10 hours of a computer training (Contact Control Group).

Behavioral: Speed of Processing Training

Internet Navigational (10 hours)

SHAM COMPARATOR

In this group, participants will receive 10 hours of Internet Navigation Training. Specifically, participants will be given instructional materials and exercises on how to navigate the Internet. For more computer savvy participants, they will be directed to the Thinks.com website. Those who receive 20 hours of speed of processing training will be compared to those participants who are randomized only to receive 10 hours speed of processing training; both of these groups will be compared to those randomized to receive only 10 hours of a computer training (Contact Control Group).

Other: Internet Navigational

Interventions

Speed of Processing Training BEHAVIORAL

These are specific computerized exercises that are designed to increase the rate in which people can process visual information.

Also known as: Insight Software

Speed of Processing Training (10 hours); Speed of Processing Training (20 hours)

Internet Navigational OTHER

This is a sham condition in which participants will receive the same amount of social and computer contact as those randomized to receive the 10 hours of speed of processing training. In this condition, participants will learn how to do various activities on the internet.

Also known as: Contact Control Condition

Internet Navigational (10 hours)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Since driving-related factors are being examined as one of the outcomes of the intervention, participants must be licensed drivers when entering the study.
• Men and/or women
• Must be 40+ years
• English speaking
• Have HIV-Associated Neurocognitive Disorder (HAND) or borderline HAND (defined using Frascati criteria).

You may not qualify if:

• Because this study is longitudinal, participants not living in stable housing (e.g., halfway house) will be excluded.
• Potential participants will be excluded if they indicate that they are planning to move outside of the Birmingham metropolitan area within the next 2 years.
• Participants with significant neuromedical co-morbidities (e.g., schizophrenia, epilepsy, bipolar disorder, multiple sclerosis, Alzheimer's disease or related dementias, mental retardation)
• Legally blind or deaf (vision confirmed at baseline)
• Currently undergoing radiation or chemotherapy
• A history of brain trauma with a loss of consciousness greater than 30 minutes
• Those who have participated in our pilot studies and were randomized to the Speed of Processing Training will be excluded.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (18)

• 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

• Vance DE, Fazeli PL, Moneyham L, Keltner NL, Raper JL. Assessing and treating forgetfulness and cognitive problems in adults with HIV. J Assoc Nurses AIDS Care. 2013 Jan-Feb;24(1 Suppl):S40-60. doi: 10.1016/j.jana.2012.03.006.

  PMID: 23290376 BACKGROUND

• Vance DE. Prevention, Rehabilitation, and Mitigation Strategies of Cognitive Deficits in Aging with HIV: Implications for Practice and Research. ISRN Nurs. 2013;2013:297173. doi: 10.1155/2013/297173. Epub 2013 Feb 3.

  PMID: 23431469 BACKGROUND

• Lin F, Chen DG, Vance D, Mapstone M. Trajectories of combined laboratory- and real world-based speed of processing in community-dwelling older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):364-73. doi: 10.1093/geronb/gbs075. Epub 2012 Sep 11.

  PMID: 22967505 BACKGROUND

• Fazeli PL, Ross LA, Vance DE, Ball K. The relationship between computer experience and computerized cognitive test performance among older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):337-46. doi: 10.1093/geronb/gbs071. Epub 2012 Aug 28.

  PMID: 22929395 BACKGROUND

• Kaur J, Dodson JE, Steadman L, Vance DE. Predictors of improvement following speed of processing training in middle-aged and older adults with HIV: a pilot study. J Neurosci Nurs. 2014 Feb;46(1):23-33. doi: 10.1097/JNN.0000000000000034.

  PMID: 24399164 BACKGROUND

• Vance DE, Fazeli PL, Azuero A, Frank JS, Wadley VG, Raper JL, Pope CN, Jacob A, Ball KK. A 2-Year, Randomized, Clinical Trial Examining the Effects of Speed of Processing Cognitive Training on Quality-of-Life Indicators in Adults With HIV-Associated Neurocognitive Disorder in Birmingham, Alabama: Results of the Think Fast Study. J Assoc Nurses AIDS Care. 2024 Mar-Apr 01;35(2):104-121. doi: 10.1097/JNC.0000000000000449. Epub 2024 Jan 18.

  PMID: 38949906 DERIVED

• Vance DE, Fazeli PL, Azuero A, Frank JS, Wadley VG, Raper JL, Pope CN, Ball KK. A 2-year longitudinal randomized controlled trial examining the transfer of speed of processing training to secondary cognitive domains in middle-aged and older adults with HIV-associated neurocognitive disorder: Results of the think fast study. Clin Neuropsychol. 2024 Feb;38(2):471-492. doi: 10.1080/13854046.2023.2212867. Epub 2023 May 16.

  PMID: 37191339 DERIVED

• Waldrop D, Irwin C, Nicholson WC, Lee CA, Webel A, Fazeli PL, Vance DE. The Intersection of Cognitive Ability and HIV: A Review of the State of the Nursing Science. J Assoc Nurses AIDS Care. 2021 May-Jun 01;32(3):306-321. doi: 10.1097/JNC.0000000000000232.

  PMID: 33449578 DERIVED

• Vance DE, Robinson J, Walker TJ, Tende F, Bradley B, Diehl D, McKie P, Fazeli PL. Reactions to a Probable Diagnosis of HIV-Associated Neurocognitive Disorder: A Content Analysis. J Assoc Nurses AIDS Care. 2020 May-Jun;31(3):279-289. doi: 10.1097/JNC.0000000000000120.

  PMID: 31436599 DERIVED

• Vance DE, Cody SL, Nicholson WC, Cheatwood J, Morrison S, Fazeli PL. The Association Between Olfactory Function and Cognition in Aging African American and Caucasian Men With HIV: A Pilot Study. J Assoc Nurses AIDS Care. 2019 Sep-Oct;30(5):e144-e155. doi: 10.1097/JNC.0000000000000086.

  PMID: 31259847 DERIVED

• Vance DE, Lee L, Munoz-Moreno JA, Morrison S, Overton T, Willig A, Fazeli PL. Cognitive Reserve Over the Lifespan: Neurocognitive Implications for Aging With HIV. J Assoc Nurses AIDS Care. 2019 Sep-Oct;30(5):e109-e121. doi: 10.1097/JNC.0000000000000071.

  PMID: 30865059 DERIVED

• Vance DE, Cody SL, Nicholson C, Cheatwood J, Morrison S, Fazeli PL. Olfactory Dysfunction in Aging African American and Caucasian Men With HIV: A Pilot Study. J Assoc Nurses AIDS Care. 2022 May-Jun 01;33(3):e19-e30. doi: 10.1097/JNC.0000000000000061.

  PMID: 30676359 DERIVED

• Vance DE, Fazeli PL, Cheatwood J, Nicholson WC, Morrison SA, Moneyham LD. Computerized Cognitive Training for the Neurocognitive Complications of HIV Infection: A Systematic Review. J Assoc Nurses AIDS Care. 2019 Jan-Feb;30(1):51-72. doi: 10.1097/JNC.0000000000000030.

  PMID: 30586083 DERIVED

• Vance DE, Blake BJ, Brennan-Ing M, DeMarco RF, Fazeli PL, Relf MV. Revisiting Successful Aging With HIV Through a Revised Biopsychosocial Model: An Update of the Literature. J Assoc Nurses AIDS Care. 2019 Jan-Feb;30(1):5-14. doi: 10.1097/JNC.0000000000000029.

  PMID: 30586079 DERIVED

• Vance DE, Jensen M, Tende F, Raper JL, Morrison S, Fazeli PL. Individualized-Targeted Computerized Cognitive Training to Treat HIV-Associated Neurocognitive Disorder: An Interim Descriptive Analysis. J Assoc Nurses AIDS Care. 2018 Jul-Aug;29(4):604-611. doi: 10.1016/j.jana.2018.04.005. Epub 2018 Apr 23. No abstract available.

  PMID: 29764716 DERIVED

• Hossain S, Fazeli PL, Tende F, Bradley B, McKie P, Vance DE. The Potential of Computerized Cognitive Training on HIV-Associated Neurocognitive Disorder: A Case Comparison Study. J Assoc Nurses AIDS Care. 2017 Nov-Dec;28(6):971-976. doi: 10.1016/j.jana.2017.06.011. Epub 2017 Jun 23. No abstract available.

  PMID: 28784586 DERIVED

• Vance D, Fazeli P, Shacka J, Nicholson W, McKie P, Raper J, Azuero A, Wadley V, Ball K. Testing a Computerized Cognitive Training Protocol in Adults Aging With HIV-Associated Neurocognitive Disorders: Randomized Controlled Trial Rationale and Protocol. JMIR Res Protoc. 2017 Apr 26;6(4):e68. doi: 10.2196/resprot.6625.

  PMID: 28446421 DERIVED

Study Officials

• David E Vance, PhD

  University of Alabama at Birmingham, School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: May 2, 2016
• Study Start: September 28, 2016
• Primary Completion: March 11, 2020
• Study Completion: March 11, 2020
• Last Updated: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)