Clinical trial NCT02216591: Improving Memory Performance by Applying Cognitive Training
Official title: Impact of Cognitive Training on Medication Adherence in HIV-infected Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Medication Adherence
Working Memory
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Working Memory
timeFrame: Baseline and 10 weeks
Secondary outcomes:
measure: Change in Delay Discounting
timeFrame: Baseline and 10 weeks
Other outcomes:
measure: Change in Mean Percent Adherence Across All Antiretroviral Medications
timeFrame: Baseline and 10 weeks
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Sheri L Towe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.