Improving Memory Performance by Applying Cognitive Training

HIV Clinical Trial

— IMPACT  

Official title:

Impact of Cognitive Training on Medication Adherence in HIV-infected Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216591
• Other study ID #: Pro00053630
• Status: Completed
• Phase: N/A
• First received: August 12, 2014
• Last updated: July 22, 2016
• Start date: August 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Device:
• Active Cognitive Training (ACT)

• Control (CON)

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in mean percent adherence across all antiretroviral medications		Baseline and 10 weeks	No
Primary	Change in working memory	Standardized neuropsychological tests of working memory	Baseline and 10 weeks	No
Secondary	Change in Delay discounting	Measured by Monetary-Choice Questionnaire (MCQ), a standardized delay discounting task	Baseline and 10 weeks	No