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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23MH118420-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This research is being done to determine if computerized administered cognitive fitness activities will improve thinking and depression in older depressed adults who are being treated with antidepressants. The investigators are also interested in whether participating in the treatment will result in changes to brain activity measured with magnetic resonance imaging (MRI).
Major depression in the elderly is both challenging to treat and detrimental to the cognitive functioning of patients. Major depression increases the probability of a later dementia diagnosis. By targeting cognitive processes in treatment, the investigators hope to both find a more effective means to manage major depression in older adults, but also demonstrate how top-down processes (e.g., Executive Control Network) may be driving depression and cognitive decline in older adults.
The investigators are recruiting older adults with and without mild cognitive impairment. All subjects must have at least mild depressive symptoms to be eligible to participate. Subjects will be randomly assigned to one of two different interventions.
Results of this study will help the investigators understand the mechanisms that contribute to depressed mood and cognitive change in older adults with late life depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computerized Cognitive Remediation of Executive Functioning (CCR-EF) | Experimental | Initially 10 hours of processing speed exercises from "Brain HQ", (the 3 exercises are auditory tone sweep, visual processing [Double Decision], visual sweep). Following the 8-10 hours of Brain HQ, participants complete 8-10 hours of "Ultimate Word Master" before completing 16-20 hours of "Neurogrow" (formerly called "Catch the Ball"). Participants are asked to complete approximately 28-42 hours of computerized brain training over 4-6 weeks. |
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| Active Control | Active Comparator | Patients in the active control arm will complete three activities according to a standard protocol: 1) play a visuospatially oriented computer game (Myst), 2) watch computer-based educational programs on art, history, literature, and 3) play computer games online through the Brain HQ platform; games include crossword puzzles, soduko, paddleboard, and word search. Participants will complete a total of 32-42 hours of training over 4-6 weeks. Time spent on each task will be evenly divided (15 minutes of each task everday). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Cognitive Remediation of Executive Functioning (CCR-EF) | Other | computerized experimental brain-training treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trail Making Part B Test | time to complete alpha-numeric sequencing measured with the Trail Making Test (Part B). Change score is Week 6 - baseline. This is a measure of cognitive processing speed and mental flexibility measured in seconds to complete the task. A participant with a (very) strong performance on this test would complete the test in 25-65 seconds. Completion time is capped at 5 minutes and participants who have not completed the test are assigned a value of 300. | Pre-treatment and six weeks later when treatment has ended |
| Montgomery Asberg Depression Rating Scale (MADRS) | Change in depression symptom severity as measured with the MADRS depression rating scale. Change score defined as week 6 - baseline (negative values indicate depression has improved). The (MADRS) ranges from 0 to 60, with 10 items scored 0-6 each. Higher scores indicate greater severity. Common cutoff points are: 0-6 (normal/remission), 7-19 (mild), 20-34 (moderate), and 35-60 (severe). Minimal clinically important difference (MCID) measured on the MADRS range from 1.6-1.9. | Pre-treatment and six weeks later when treatment has ended |
| Measure | Description | Time Frame |
|---|---|---|
| California Verbal Learning Test (CVLT) Total Learning | Change in verbal learning as measured with the CVLT total learning score. The CVLT learning test includes a 16-item wordlist that is read to the participant five times. So the total possible maximum score on this measure is 80 and the total possible minimum score is 0. The change score is defined as week 6 - baseline, so a positive score indicates improved performance at week 6 compared with baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Manning, Ph.D. | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UConn Health | Farmington | Connecticut | 06030 | United States |
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Data will be available March 2025
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We used a comprehensive cognitive battery to classify patients as cognitively normal (CN), mild cognitive impairment (MCI), or excluded due to dementia.
Recruitment of subjects was carried out by several mechanisms, including:
A) Referral from the psychiatry outpatient clinic, the geriatric medicine clinic at UCHC, and geriatricians in the community. Additional recruitment methods included community talks where participation in the research study was offered; distribution of flyers to include community housing, churches, organizations, medical clinics, and community centers; and advertising in newspapers, magazines, etc.
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| ID | Title | Description |
|---|---|---|
| FG000 | NeuroFlex Intervention Group | Participants engage in a series of computerized cognitive training exercises over the course of several weeks. Specifically, participants in the current study were asked to complete one hour of cognitive training exercises every day for six weeks. Participants were first asked to use "Brain HQ," a commercially available software platform, for one week in order to enhance basic visual and auditory attention / processing speed using the exercises Sound Sweeps, Auditory Sweeps, and Double-Decision. Next, in Weeks 2-6, participants began training with Ultimate Word Master and NeuroFlex, games designed to leverage principles of induction of plasticity in the aging brain from basic animal models and translate them into multisensory, dynamic difficulty adjusted, increasingly challenging, and immediately rewarding cognitive control training. The games include individual, trial-by-trial performance monitoring and the use of gaming mechanics to facilitate flexible adaptation to participant's cognitive control abilities in real time. Ultimate Word Master is designed to enhance the executive functions of categorization and verbalabstraction. NeuroFlex is designed to enhance the component functions of cognitive flexibility (e.g., inhibition of prepotent responses, adaptive strategy) |
| FG001 | Computerized Control Group | Our control training follows general recommendations for cognitive fitness and has been used in several other cognitive remediation studies to keep partici pants blinded to their group assignment. Patients in the control arm completed three tablet-based activities according to a standard protocol that matched the intervention group for tablet use and treatment duration: 1) play a visuospatial oriented computer game (RealMyst), 2) watch educational programs on history, literature, and scientific topics, and 3) read online. Participants were asked to complete 20 minutes of each activity per day for six weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | NeuroFlex Intervention Group | Participants engage in a series of computerized cognitive training exercises over the course of several weeks. Specifically, participants in the current study were asked to complete one hour of cognitive training exercises every day for six weeks. Participants were first asked to use "Brain HQ," a commercially available software platform, for one week in order to enhance basic visual and auditory attention / processing speed using the exercises Sound Sweeps, Auditory Sweeps, and Double-Decision. Next, in Weeks 2-6, participants began training with Ultimate Word Master and NeuroFlex, games designed to leverage principles of induction of plasticity in the aging brain from basic animal models and translate them into multisensory, dynamic difficulty adjusted, increasingly challenging, and immediately rewarding cognitive control training. The games include individual, trial-by-trial performance monitoring and the use of gaming mechanics to facilitate flexible adaptation to participant's cognitive control abilities in real time. Ultimate Word Master is designed to enhance the executive functions of categorization and verbalabstraction. NeuroFlex is designed to enhance the component functions of cognitive flexibility (e.g., inhibition of prepotent responses, adaptive strategy) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Trail Making Part B Test | time to complete alpha-numeric sequencing measured with the Trail Making Test (Part B). Change score is Week 6 - baseline. This is a measure of cognitive processing speed and mental flexibility measured in seconds to complete the task. A participant with a (very) strong performance on this test would complete the test in 25-65 seconds. Completion time is capped at 5 minutes and participants who have not completed the test are assigned a value of 300. | Posted | Mean | Standard Deviation | seconds | Pre-treatment and six weeks later when treatment has ended |
|
From enrollment to the end of follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NeuroFlex Intervention Group | Participants engage in a series of computerized cognitive training exercises over the course of several weeks. Specifically, participants in the current study were asked to complete one hour of cognitive training exercises every day for six weeks. Participants were first asked to use "Brain HQ," a commercially available software platform, for one week in order to enhance basic visual and auditory attention / processing speed using the exercises Sound Sweeps, Auditory Sweeps, and Double-Decision. Next, in Weeks 2-6, participants began training with Ultimate Word Master and NeuroFlex, games designed to leverage principles of induction of plasticity in the aging brain from basic animal models and translate them into multisensory, dynamic difficulty adjusted, increasingly challenging, and immediately rewarding cognitive control training. The games include individual, trial-by-trial performance monitoring and the use of gaming mechanics to facilitate flexible adaptation to participant's cognitive control abilities in real time. Ultimate Word Master is designed to enhance the executive functions of categorization and verbalabstraction. NeuroFlex is designed to enhance the component functions of cognitive flexibility (e.g., inhibition of prepotent responses, adaptive strategy) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| suicidal ideation | Psychiatric disorders | suicidal ideation | Systematic Assessment |
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Limitations include the small sample that was recruited.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin J Manning | University of Connecticut | 860-679-2272 | manning@uchc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2024 | Mar 18, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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| Active Control | Other | computerized intervention that follows recommendations for cognitive fitness |
|
| Pre-treatment and six weeks later when treatment has ended |
| NIH Toolbox Pattern Comparison Speed Task | A computerized test of speed of simple processing speed where participants look at two figures and respond as quickly as possible whether those figures are alike or different. Scores are demographic adjusted T scores (adjusted for age, sex, education). T scores have a mean of 50 and a standard deviation of 10. T scores less than 35 indicate impaired performance. A change Score is here defined as Week 6 - Baseline (positive T scores indicate improved performance over the trial). A mean performance of +10 would mean on average that group improved by an entire standard deviation. | Pre-treatment and six weeks later when treatment has ended |
| BG001 | Computerized Control Group | Our control training follows general recommendations for cognitive fitness and has been used in several other cognitive remediation studies to keep partici pants blinded to their group assignment. Patients in the control arm completed three tablet-based activities according to a standard protocol that matched the intervention group for tablet use and treatment duration: 1) play a visuospatial oriented computer game (RealMyst), 2) watch educational programs on history, literature, and scientific topics, and 3) read online. Participants were asked to complete 20 minutes of each activity per day for six weeks. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Computerized Control Group | Our control training follows general recommendations for cognitive fitness and has been used in several other cognitive remediation studies to keep partici pants blinded to their group assignment. Patients in the control arm completed three tablet-based activities according to a standard protocol that matched the intervention group for tablet use and treatment duration: 1) play a visuospatial oriented computer game (RealMyst), 2) watch educational programs on history, literature, and scientific topics, and 3) read online. Participants were asked to complete 20 minutes of each activity per day for six weeks. |
|
|
| Primary | Montgomery Asberg Depression Rating Scale (MADRS) | Change in depression symptom severity as measured with the MADRS depression rating scale. Change score defined as week 6 - baseline (negative values indicate depression has improved). The (MADRS) ranges from 0 to 60, with 10 items scored 0-6 each. Higher scores indicate greater severity. Common cutoff points are: 0-6 (normal/remission), 7-19 (mild), 20-34 (moderate), and 35-60 (severe). Minimal clinically important difference (MCID) measured on the MADRS range from 1.6-1.9. | Posted | Mean | Standard Deviation | points on depression rating scale | Pre-treatment and six weeks later when treatment has ended |
|
|
|
| Secondary | California Verbal Learning Test (CVLT) Total Learning | Change in verbal learning as measured with the CVLT total learning score. The CVLT learning test includes a 16-item wordlist that is read to the participant five times. So the total possible maximum score on this measure is 80 and the total possible minimum score is 0. The change score is defined as week 6 - baseline, so a positive score indicates improved performance at week 6 compared with baseline. | Posted | Mean | Standard Deviation | words recalled | Pre-treatment and six weeks later when treatment has ended |
|
|
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| Secondary | NIH Toolbox Pattern Comparison Speed Task | A computerized test of speed of simple processing speed where participants look at two figures and respond as quickly as possible whether those figures are alike or different. Scores are demographic adjusted T scores (adjusted for age, sex, education). T scores have a mean of 50 and a standard deviation of 10. T scores less than 35 indicate impaired performance. A change Score is here defined as Week 6 - Baseline (positive T scores indicate improved performance over the trial). A mean performance of +10 would mean on average that group improved by an entire standard deviation. | Posted | Mean | Standard Deviation | T-score | Pre-treatment and six weeks later when treatment has ended |
|
|
|
| 0 |
| 15 |
| 1 |
| 15 |
| 0 |
| 15 |
| EG001 | Computerized Control Group | Our control training follows general recommendations for cognitive fitness and has been used in several other cognitive remediation studies to keep partici pants blinded to their group assignment. Patients in the control arm completed three tablet-based activities according to a standard protocol that matched the intervention group for tablet use and treatment duration: 1) play a visuospatial oriented computer game (RealMyst), 2) watch educational programs on history, literature, and scientific topics, and 3) read online. Participants were asked to complete 20 minutes of each activity per day for six weeks. | 0 | 18 | 0 | 18 | 0 | 18 |
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| D019965 |
| Neurocognitive Disorders |