<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02216591</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00053630</org_study_id>
    <nct_id>NCT02216591</nct_id>
  </id_info>
  <brief_title>Improving Memory Performance by Applying Cognitive Training</brief_title>
  <acronym>IMPACT</acronym>
  <official_title>Impact of Cognitive Training on Medication Adherence in HIV-infected Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study will test the efficacy of a cognitive training program to improve working&#xD;
      memory in a sample of HIV-infected persons. Investigators will assign 40 HIV-infected adults&#xD;
      with poor medication adherence to one of two conditions (20/group): the experimental&#xD;
      cognitive training intervention or a control training condition. Participants will complete&#xD;
      12 training sessions across 10 weeks and will complete assessments at baseline and&#xD;
      post-training. The specific aims are to:&#xD;
&#xD;
        1. Investigate the effects of the cognitive training intervention on working memory and&#xD;
           delay discounting in HIV-infected persons.&#xD;
&#xD;
           Hypothesis 1: Participants assigned to active cognitive training, compared to those in&#xD;
           the attention-matched control group, will have greater improvements in working memory&#xD;
           and reductions in delay discounting.&#xD;
&#xD;
        2. Characterize adherence to antiretroviral medications in this population and examine&#xD;
           medication adherence after cognitive training.&#xD;
&#xD;
      Hypothesis 2: Participants assigned to active cognitive training, compared to those in the&#xD;
      attention-matched control group, will have greater improvements in medication adherence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study tests the feasibility and preliminary efficacy of a computerized cognitive&#xD;
      training program to improve working memory and decrease impulsivity among HIV-infected&#xD;
      individuals with poor medication adherence. The specific aims are to: (1) Investigate the&#xD;
      effects of the cognitive training intervention on working memory and delay discounting in&#xD;
      HIV-infected persons; and (2) Characterize adherence to antiretroviral medications in this&#xD;
      population and examine medication adherence after cognitive training.&#xD;
&#xD;
      The research design includes two parts: an eligibility screening and the Cognitive Training&#xD;
      study. In Part 1, Eligibility Screening, participants will complete a 2-3 hour battery of&#xD;
      standardized measures to assess for study eligibility. Eligible individuals will then be&#xD;
      invited to enroll in Part 2, Cognitive Training Study. Part 1 of the study will involved&#xD;
      screening approximately 60 participants, with an estimated eligibility rate of 67% for Part&#xD;
      2. In Part 2, participants will be assigned to one of two groups (active cognitive training&#xD;
      or control training; 20 participants per group) and will complete 12 training sessions over&#xD;
      10 weeks. Participants assigned to the active cognitive training group will complete&#xD;
      computerized modules designed to enhance working memory, while those assigned to the&#xD;
      attention-matched control group will complete inactive modules that are not designed to&#xD;
      enhance memory. All Part 2 participants will complete assessments at baseline and&#xD;
      post-training to evaluate the impact of the training program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 29, 2016</completion_date>
  <primary_completion_date type="Actual">June 29, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Working Memory</measure>
    <time_frame>Baseline and 10 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Delay Discounting</measure>
    <time_frame>Baseline and 10 weeks</time_frame>
    <description>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., &quot;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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Mean Percent Adherence Across All Antiretroviral Medications</measure>
    <time_frame>Baseline and 10 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Active Cognitive Training (ACT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (CON)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active Cognitive Training (ACT)</intervention_name>
    <arm_group_label>Active Cognitive Training (ACT)</arm_group_label>
    <other_name>PSSCogRehab 2012, published by Psychological Software Service</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control (CON)</intervention_name>
    <arm_group_label>Control (CON)</arm_group_label>
    <other_name>PSSCogRehab 2012, published by Psychological Software Service</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV infection, diagnosed for &gt; 6 months&#xD;
&#xD;
          -  Currently on treatment with antiretroviral medications for &gt; 3 months&#xD;
&#xD;
          -  Self-reported medication adherence at less than 90%&#xD;
&#xD;
          -  Lives within 15 miles of the research site in stable housing and with no plans to move&#xD;
             from the area in the next 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current substance use disorder&#xD;
&#xD;
          -  Any drug use other than alcohol or marijuana in the past year&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  English non-fluency or illiteracy&#xD;
&#xD;
          -  ≤ 8th grade education&#xD;
&#xD;
          -  serious neurological disorders, including HIV dementia&#xD;
&#xD;
          -  traumatic brain injury&#xD;
&#xD;
          -  severe mental illness or acute psychiatric distress&#xD;
&#xD;
          -  impaired mental status&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheri L Towe, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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>
    <PMID>20965498</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19291386</PMID>
  </reference>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <results_first_submitted>April 19, 2017</results_first_submitted>
  <results_first_submitted_qc>May 23, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 28, 2017</results_first_posted>
  <last_update_submitted>May 23, 2017</last_update_submitted>
  <last_update_submitted_qc>May 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Medication Adherence</keyword>
  <keyword>Working Memory</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Adult persons living with HIV were recruited from the Durham area between January 2015 and May 2016 via flyers and brochures at community-based organizations and infectious diseases clinics.</recruitment_details>
      <pre_assignment_details>Interested persons completed a comprehensive in-person eligibility screen prior to group assignment. 33 participants completed the in-person screen, and 12 were not eligible (5 had no memory impairment, 3 had a current substance use disorder, 2 had a history of brain injury, 1 had severe mental illness, and 1 was not interested).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Active Cognitive Training (ACT)</title>
          <description>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.&#xD;
Active Cognitive Training (ACT)</description>
        </group>
        <group group_id="P2">
          <title>Control (CON)</title>
          <description>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.&#xD;
Control (CON)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Active Cognitive Training (ACT)</title>
          <description>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.&#xD;
Active Cognitive Training (ACT)</description>
        </group>
        <group group_id="B2">
          <title>Control (CON)</title>
          <description>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.&#xD;
Control (CON)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="21"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.27" spread="8.37"/>
                    <measurement group_id="B2" value="44.20" spread="13.01"/>
                    <measurement group_id="B3" value="47.90" spread="11.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Working Memory</title>
        <description>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.</description>
        <time_frame>Baseline and 10 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Cognitive Training (ACT)</title>
            <description>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.&#xD;
Active Cognitive Training (ACT)</description>
          </group>
          <group group_id="O2">
            <title>Control (CON)</title>
            <description>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.&#xD;
Control (CON)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Working Memory</title>
          <description>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.</description>
          <units>mean T score on working memory tests</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.33" spread="2.69"/>
                    <measurement group_id="O2" value="43.15" spread="2.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.013</p_value>
            <method>ANCOVA</method>
            <method_desc>Mixed-model general linear model with age and education included as covariates. Time x arm interaction was significant, F(1,16) = 7.76, p = 0.013.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Delay Discounting</title>
        <description>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., &quot;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.</description>
        <time_frame>Baseline and 10 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Cognitive Training (ACT)</title>
            <description>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.&#xD;
Active Cognitive Training (ACT)</description>
          </group>
          <group group_id="O2">
            <title>Control (CON)</title>
            <description>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.&#xD;
Control (CON)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Delay Discounting</title>
          <description>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., &quot;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.</description>
          <units>Mean K value rank for MCQ</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.62" spread="1.76"/>
                    <measurement group_id="O2" value="8.81" spread="1.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.274</p_value>
            <method>ANCOVA</method>
            <method_desc>Mixed-model general linear model with age and education included as covariates. Time x arm interaction was not significant, F(1,16) = 1.29, p = 0.274</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Mean Percent Adherence Across All Antiretroviral Medications</title>
        <time_frame>Baseline and 10 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Cognitive Training (ACT)</title>
            <description>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.&#xD;
Active Cognitive Training (ACT)</description>
          </group>
          <group group_id="O2">
            <title>Control (CON)</title>
            <description>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.&#xD;
Control (CON)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Percent Adherence Across All Antiretroviral Medications</title>
          <units>Percent of doses</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.09" spread="13.57"/>
                    <measurement group_id="O2" value="95.11" spread="10.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.410</p_value>
            <method>ANCOVA</method>
            <method_desc>Mixed-model general linear model with age and education included as covariates. Time x arm interaction was not significant, F(1,16) = .72, p = 0.410</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 10 weeks (from Baseline to the 10-week assessment)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Active Cognitive Training (ACT)</title>
          <description>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.&#xD;
Active Cognitive Training (ACT)</description>
        </group>
        <group group_id="E2">
          <title>Control (CON)</title>
          <description>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.&#xD;
Control (CON)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The overall target sample size of 40 was not reached, and therefore we may have been underpowered to detect differences on secondary outcome measures.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Sheri Towe</name_or_title>
      <organization>Duke University School of Medicine</organization>
      <phone>919-668-4030</phone>
      <email>sheri.towe@duke.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02216591
org study id: Pro00053630
nct id: NCT02216591
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Working Memory
time frame: Baseline and 10 weeks
description: 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.
measure: Change in Delay Discounting
time frame: Baseline and 10 weeks
description: 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.
measure: Change in Mean Percent Adherence Across All Antiretroviral Medications
time frame: Baseline and 10 weeks
arm group label: Active Cognitive Training (ACT)
arm group type: Experimental
description: 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.
arm group label: Control (CON)
arm group type: Sham Comparator
description: 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.
intervention type: Device
intervention name: Active Cognitive Training (ACT)
arm group label: Active Cognitive Training (ACT)
other name: PSSCogRehab 2012, published by Psychological Software Service
intervention type: Device
intervention name: Control (CON)
arm group label: Control (CON)
other name: PSSCogRehab 2012, published by Psychological Software Service
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Sheri L Towe, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
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.
PMID: 20965498
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.
PMID: 19291386
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The overall target sample size of 40 was not reached, and therefore we may have been underpowered to detect differences on secondary outcome measures.
point of contact: 