NCT02216591

Brief Summary

The proposed study will test the efficacy of a cognitive training program to improve working memory in a sample of HIV-infected persons. Investigators will assign 40 HIV-infected adults with poor medication adherence to one of two conditions (20/group): the experimental cognitive training intervention or a control training condition. Participants will complete 12 training sessions across 10 weeks and will complete assessments at baseline and post-training. The specific aims are to:

  1. 1.Investigate the effects of the cognitive training intervention on working memory and delay discounting in HIV-infected persons.
  2. 2.Characterize adherence to antiretroviral medications in this population and examine medication adherence after cognitive training.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2016

Completed
12 months until next milestone

Results Posted

Study results publicly available

June 28, 2017

Completed
Last Updated

June 28, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

August 12, 2014

Results QC Date

April 19, 2017

Last Update Submit

May 23, 2017

Conditions

HIV

Keywords

HIVMedication AdherenceWorking Memory

Outcome Measures

Primary Outcomes (1)

  • Change in Working Memory

    Standardized neuropsychological tests of working memory used in this study were the Paced Auditory Serial Addition Task-50 and Neuropsychological Assessment Battery Digits Forward/Digits Backward Test. Using the most up-to-date published normative data, raw test scores were converted to T-scores that corrected for demographic factors such as age and education. T scores can range from 0 to 100, with 50 being average and higher scores indicating better function. The overall working memory score was computed by averaging T-scores of each of the individual tests. To examine intervention effects on working memory outcomes, we conducted a 2 (Arm: ACT vs. CON) × 2 (Time: Baseline vs. Post) mixed-model general linear model analyses. Time was the within-subjects factor defined by baseline versus 10 week follow-up, and study arm was the between-subjects factor. Age and years of education were included as covariates. The means reported here are the mean scores at 10 weeks.

    Baseline and 10 weeks

Secondary Outcomes (1)

  • Change in Delay Discounting

    Baseline and 10 weeks

Other Outcomes (1)

  • Change in Mean Percent Adherence Across All Antiretroviral Medications

    Baseline and 10 weeks

Study Arms (2)

Active Cognitive Training (ACT)

EXPERIMENTAL

The ACT group will complete 12 individual sessions across 6-10 weeks. Sessions will utilize four commercially available memory-training programs from PSSCogRehab 2012, published by Psychological Software Service. The four programs used will be: (1) Sequence recall of digits - auditory (SRD-A), (2) Sequenced Recall Reversed Digits - Auditory (SRRD-A), (3) Sequenced Recall of Words - Visual (SRW-V), and (4) Verbal memory - categorizing (VM-C). In each training session, participants will complete each of the four memory training programs twice.

Device: Active Cognitive Training (ACT)

Control (CON)

SHAM COMPARATOR

The CON group will also complete 12 total sessions across 6-10 weeks. The same four computer programs from PSSCogRehab 2012, published by Psychological Software Service, will be used in the control group sessions. However, the control program will identify the correct responses to participants, such that they do not need to engage their working memory to answer the questions correctly.

Device: Control (CON)

Interventions

Active Cognitive Training (ACT)DEVICE
Also known as: PSSCogRehab 2012, published by Psychological Software Service
Active Cognitive Training (ACT)
Control (CON)DEVICE
Also known as: PSSCogRehab 2012, published by Psychological Software Service
Control (CON)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HIV infection, diagnosed for \> 6 months
  • Currently on treatment with antiretroviral medications for \> 3 months
  • Self-reported medication adherence at less than 90%
  • Lives within 15 miles of the research site in stable housing and with no plans to move from the area in the next 3 months

You may not qualify if:

  • Current substance use disorder
  • Any drug use other than alcohol or marijuana in the past year
  • Pregnancy
  • English non-fluency or illiteracy
  • ≤ 8th grade education
  • serious neurological disorders, including HIV dementia
  • traumatic brain injury
  • severe mental illness or acute psychiatric distress
  • impaired mental status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

Related Publications (2)

  • Bickel WK, Yi R, Landes RD, Hill PF, Baxter C. Remember the future: working memory training decreases delay discounting among stimulant addicts. Biol Psychiatry. 2011 Feb 1;69(3):260-5. doi: 10.1016/j.biopsych.2010.08.017. Epub 2010 Oct 20.

    PMID: 20965498BACKGROUND

  • Lovejoy TI, Suhr JA. The relationship between neuropsychological functioning and HAART adherence in HIV-positive adults: a systematic review. J Behav Med. 2009 Oct;32(5):389-405. doi: 10.1007/s10865-009-9212-9. Epub 2009 Mar 17.

    PMID: 19291386BACKGROUND

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Limitations and Caveats

The overall target sample size of 40 was not reached, and therefore we may have been underpowered to detect differences on secondary outcome measures.

Results Point of Contact

Title
Dr. Sheri Towe
Organization
Duke University School of Medicine
sheri.towe@duke.edu
919-668-4030

Study Officials

  • Sheri L Towe, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2014

First Posted

August 15, 2014

Study Start

August 1, 2014

Primary Completion

June 29, 2016

Study Completion

June 29, 2016

Last Updated

June 28, 2017

Results First Posted

June 28, 2017

Record last verified: 2017-05

Locations

US(1)