Improving Memory Performance by Applying Cognitive Training

NCT ID: NCT02216591

Last Updated: 2017-06-28

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-06-29

Brief Summary

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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. Investigate the effects of the cognitive training intervention on working memory and delay discounting in HIV-infected persons.

Hypothesis 1: Participants assigned to active cognitive training, compared to those in the attention-matched control group, will have greater improvements in working memory and reductions in delay discounting.
2. Characterize adherence to antiretroviral medications in this population and examine medication adherence after cognitive training.

Hypothesis 2: Participants assigned to active cognitive training, compared to those in the attention-matched control group, will have greater improvements in medication adherence.

Detailed Description

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This study tests the feasibility and preliminary efficacy of a computerized cognitive training program to improve working memory and decrease impulsivity among HIV-infected individuals with poor medication adherence. The specific aims are to: (1) Investigate the effects of the cognitive training intervention on working memory and delay discounting in HIV-infected persons; and (2) Characterize adherence to antiretroviral medications in this population and examine medication adherence after cognitive training.

The research design includes two parts: an eligibility screening and the Cognitive Training study. In Part 1, Eligibility Screening, participants will complete a 2-3 hour battery of standardized measures to assess for study eligibility. Eligible individuals will then be invited to enroll in Part 2, Cognitive Training Study. Part 1 of the study will involved screening approximately 60 participants, with an estimated eligibility rate of 67% for Part 2. In Part 2, participants will be assigned to one of two groups (active cognitive training or control training; 20 participants per group) and will complete 12 training sessions over 10 weeks. Participants assigned to the active cognitive training group will complete computerized modules designed to enhance working memory, while those assigned to the attention-matched control group will complete inactive modules that are not designed to enhance memory. All Part 2 participants will complete assessments at baseline and post-training to evaluate the impact of the training program.

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active Cognitive Training (ACT)

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.

Group Type EXPERIMENTAL

Active Cognitive Training (ACT)

Intervention Type DEVICE

Control (CON)

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.

Group Type SHAM_COMPARATOR

Control (CON)

Intervention Type DEVICE

Interventions

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Active Cognitive Training (ACT)

Intervention Type DEVICE

Control (CON)

Intervention Type DEVICE

Other Intervention Names

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PSSCogRehab 2012, published by Psychological Software Service PSSCogRehab 2012, published by Psychological Software Service

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sheri L Towe, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20965498 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19291386 (View on PubMed)

Other Identifiers

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Pro00053630

Identifier Type: -

Identifier Source: org_study_id

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