HIVIMPACTNCT02216591
Improving Memory Performance by Applying Cognitive Training
A study testing Active Cognitive Training (ACT) in people with HIV, run by Duke University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV
- What is being tested?
- Active Cognitive Training (ACT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 29 Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- traumatic brain injury
- severe mental illness or acute psychiatric distress
- impaired mental status
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27708
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV
- Being tested
- Active Cognitive Training (ACT), Control (CON)
- Keywords
- HIV, Medication Adherence, Working Memory
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Cognitive Training (ACT)Device
Also called PSSCogRehab 2012, published by Psychological Software Service
Control (CON)Device
Also called PSSCogRehab 2012, published by Psychological Software Service
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Control (CON) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 10 weeks
Secondary outcomes (1)
Change in Delay Discounting
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.
Measured: Baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2014
- Primary completion29 Jun 2016
- Study completion29 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheri L Towe, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216591
- Sponsor's protocol ID
- Pro00053630
- Acronym
- IMPACT
- Status last verified
- May 2017
- First submitted
- 12 Aug 2014
- Last updated
- 28 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 20965498Lovejoy 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.
PubMed 19291386
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cognitive Training on Medication Adherence in HIV-infected Individuals
- ClinicalTrials.gov ID
- NCT02216591
- Acronym / sponsor ID
- IMPACT / Pro00053630
- Conditions
- HIV
- Keywords
- HIV, Medication Adherence, Working Memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- 29 Jun 2016 (actual)
- Study completion
- 29 Jun 2016 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Posted 28 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Cognitive Training (ACT) | Experimental | Device: 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. |
| Control (CON) | Sham comparator | 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Cognitive Training (ACT)Also: PSSCogRehab 2012, published by Psychological Software Service | Device | Active Cognitive Training (ACT) |
| Control (CON)Also: PSSCogRehab 2012, published by Psychological Software Service | Device | Control (CON) |
Primary outcome
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.
1 secondary outcome
Change in Delay Discounting
Time frame: Baseline and 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20965498Bickel 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.
- Background: PubMed 19291386Lovejoy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheri L Towe, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Cognitive Training (ACT) in people with HIV, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Working Memory (time frame: Baseline and 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02216591, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.