- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02216591
Improving Memory Performance by Applying Cognitive Training (IMPACT)
Impact of Cognitive Training on Medication Adherence in HIV-infected Individuals
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:
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.
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27708
- Duke University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Other Names:
|
Sham Comparator: 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.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Working Memory
Time Frame: Baseline and 10 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Delay Discounting
Time Frame: Baseline and 10 weeks
|
Measured by Monetary-Choice Questionnaire (MCQ), a standardized task that measures delay discounting.
Participants are presented with choices between smaller, immediate rewards and larger, delayed rewards (e.g., "Would you prefer $54 today or $80 in 30 days?).
Participants' hyperbolic discount parameter (k value) is determined by fitting data to the following discount function equation: Vimmediate = Vdelayed / (1 + kD), in which V is the reward value in dollars and D is delay in days.
K-values on this scale can range from 0.00016 to 4.00 and to normalize scores, these values were ranked from 1 to 13 for analyses.
A higher rank indicates greater delay discounting.
|
Baseline and 10 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Mean Percent Adherence Across All Antiretroviral Medications
Time Frame: Baseline and 10 weeks
|
Baseline and 10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sheri L Towe, PhD, Duke University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00053630
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRecruitingHIV | HIV Testing | HIV Linkage to Care | HIV TreatmentUnited States
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement and other collaboratorsUnknownHIV | HIV-uninfected Children | Children Exposed to HIVCameroon
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationCompletedPartner HIV Testing | Couple HIV Counseling | Couple Communication | HIV IncidenceCameroon, Dominican Republic, Georgia, India
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University... and other collaboratorsRecruiting
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH); Fenway Community Health; Tuberculosis...CompletedHIV/STI Risk | HIV/STI IncidenceUnited States, India
-
Erasmus Medical CenterNot yet recruitingHIV Infections | Hiv | HIV-1-infection | HIV I InfectionNetherlands
-
Hospital Clinic of BarcelonaCompletedIntegrase Inhibitors, HIV; HIV PROTEASE INHIBSpain
-
University of Maryland, BaltimoreWithdrawnHiv | Kidney Transplant | HIV Reservoir | CCR5United States
-
National Taiwan UniversityRecruiting
Clinical Trials on Active Cognitive Training (ACT)
-
Duke UniversityCompletedHIV | Cocaine Use DisordersUnited States
-
VA Office of Research and DevelopmentCompleted
-
Rick GuliziaCompletedPosttraumatic Stress Disorder
-
Veterans Medical Research FoundationNational Institute of Mental Health (NIMH)Completed
-
Beijing Anzhen HospitalBeijing Wispirit Technology Co., LtdCompletedCognitive Impairment | Atrial FibrillationChina
-
Posit Science CorporationFogarty International Center of the National Institute of HealthCompletedAttention Deficit Hyperactivity DisorderIndia
-
University GhentCompletedMajor Depression in RemissionBelgium
-
Federal University of ParaíbaUniversidade Federal do Rio Grande do NorteUnknownParkinson Disease | Motor Disorders | Cognition Disorder
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloNot yet recruitingCOVID-19 | Cognitive Impairment | Post-Acute Sequelae of SARS-CoV-2 Infection
-
Sorlandet Hospital HFOslo University Hospital; University of Maryland; St. Olavs Hospital; Barrow Neurological... and other collaboratorsRecruitingMild Cognitive ImpairmentNorway