Trial Outcomes & Findings for Cognitive Fitness for Depression in Older Adults (NCT NCT04790630)
NCT ID: NCT04790630
Last Updated: 2026-04-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
Pre-treatment and six weeks later when treatment has ended
Results posted on
2026-04-29
Participant Flow
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.
We used a comprehensive cognitive battery to classify patients as cognitively normal (CN), mild cognitive impairment (MCI), or excluded due to dementia.
Participant milestones
| Measure |
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)
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
15
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Fitness for Depression in Older Adults
Baseline characteristics by cohort
| Measure |
NeuroFlex Intervention Group
n=15 Participants
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)
|
Computerized Control Group
n=18 Participants
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.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=9 Participants
|
3 Participants
n=24 Participants
|
4 Participants
n=23 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=9 Participants
|
15 Participants
n=24 Participants
|
29 Participants
n=23 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=9 Participants
|
15 Participants
n=24 Participants
|
28 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
3 Participants
n=24 Participants
|
5 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=9 Participants
|
16 Participants
n=24 Participants
|
29 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: Pre-treatment and six weeks later when treatment has endedtime 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.
Outcome measures
| Measure |
NeuroFlex Intervention Group
n=15 Participants
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)
|
Computerized Control Group
n=18 Participants
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.
|
|---|---|---|
|
Trail Making Part B Test
|
5.06 seconds
Standard Deviation 59.01
|
-1.55 seconds
Standard Deviation 23.71
|
PRIMARY outcome
Timeframe: Pre-treatment and six weeks later when treatment has endedChange 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.
Outcome measures
| Measure |
NeuroFlex Intervention Group
n=15 Participants
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)
|
Computerized Control Group
n=18 Participants
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.
|
|---|---|---|
|
Montgomery Asberg Depression Rating Scale (MADRS)
|
-4.40 points on depression rating scale
Standard Deviation 6.59
|
-2.61 points on depression rating scale
Standard Deviation 7.97
|
SECONDARY outcome
Timeframe: Pre-treatment and six weeks later when treatment has endedChange 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.
Outcome measures
| Measure |
NeuroFlex Intervention Group
n=15 Participants
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)
|
Computerized Control Group
n=18 Participants
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.
|
|---|---|---|
|
California Verbal Learning Test (CVLT) Total Learning
|
3.08 words recalled
Standard Deviation 10.29
|
4.40 words recalled
Standard Deviation 11.76
|
SECONDARY outcome
Timeframe: Pre-treatment and six weeks later when treatment has endedA 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.
Outcome measures
| Measure |
NeuroFlex Intervention Group
n=15 Participants
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)
|
Computerized Control Group
n=18 Participants
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.
|
|---|---|---|
|
NIH Toolbox Pattern Comparison Speed Task
|
11.44 T-score
Standard Deviation 12.18
|
2.20 T-score
Standard Deviation 13.55
|
Adverse Events
NeuroFlex Intervention Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Computerized Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NeuroFlex Intervention Group
n=15 participants at risk
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)
|
Computerized Control Group
n=18 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
suicidal ideation
|
6.7%
1/15 • From enrollment to the end of follow-up.
|
0.00%
0/18 • From enrollment to the end of follow-up.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place