Trial Outcomes & Findings for Computerized Cognitive Training in Breast Cancer Survivors (NCT NCT05570604)
NCT ID: NCT05570604
Last Updated: 2025-04-24
Results Overview
Likert-based 8-item questionnaire rating overall satisfaction, quality of training, etc. 4-point scale (range from 8-32) with higher scores indicating greater acceptability and satisfaction.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
Within 1 week post-intervention
Results posted on
2025-04-24
Participant Flow
Participant milestones
| Measure |
Cognitive Training
As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.
Sweep Seeker: The goal is to enable the person to increase speed and accuracy of visual processing (executive function) and visual memory.
Bird Safari: The goal is to improve speed and accuracy of object identification in peripheral vision and improve visual precision important for improving memory.
Jewel Diver: The goal is to improve divided visual attention, sustained visual attention, visual working memory, and visual precision.
Master Gardener: The goal is to increase speed and accuracy as well as the ability to extract information accurately.
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Attention Control
Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.
Computerized Crossword Puzzles: The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.
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|---|---|---|
|
Overall Study
STARTED
|
22
|
24
|
|
Overall Study
COMPLETED
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
Cognitive Training
As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.
Sweep Seeker: The goal is to enable the person to increase speed and accuracy of visual processing (executive function) and visual memory.
Bird Safari: The goal is to improve speed and accuracy of object identification in peripheral vision and improve visual precision important for improving memory.
Jewel Diver: The goal is to improve divided visual attention, sustained visual attention, visual working memory, and visual precision.
Master Gardener: The goal is to increase speed and accuracy as well as the ability to extract information accurately.
|
Attention Control
Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.
Computerized Crossword Puzzles: The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
|
Overall Study
Illness
|
2
|
2
|
Baseline Characteristics
Computerized Cognitive Training in Breast Cancer Survivors
Baseline characteristics by cohort
| Measure |
Cognitive Training
n=19 Participants
As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested in this study. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.
|
Attention Control
n=17 Participants
Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.
Computerized Crossword Puzzles: The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Customized
Current Age
|
56.3 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
58.8 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
17 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Marital Status
Single/divorced/widowed
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Marital Status
Married/partnered
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Stage of Breast Cancer
Stage I
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Stage of Breast Cancer
Stage II
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Stage of Breast Cancer
Stage III
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Stage of Breast Cancer
Unsure
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 1 week post-interventionLikert-based 8-item questionnaire rating overall satisfaction, quality of training, etc. 4-point scale (range from 8-32) with higher scores indicating greater acceptability and satisfaction.
Outcome measures
| Measure |
Cognitive Training
n=19 Participants
As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested in this study. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.
|
Attention Control
n=17 Participants
Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.
Computerized Crossword Puzzles: The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.
|
|---|---|---|
|
Client Satisfaction Questionnaire
|
29.7 score on a scale
Standard Deviation 6.0
|
27.9 score on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Baseline and within 1 week post-interventionPerceived Cognitive Impairment (PCI) measured using 8-item, 5-point Likert scales with range from 8-40. The Cognitive Abilities Scale items target positive self-assessments of cognitive functioning with higher scores indicating better cognitive ability. The Cognitive Concerns Scale items are worded negatively and express concerns in the same area with higher scores indicating more cognitive concerns. Outcomes are controlled for the baseline assessment.
Outcome measures
| Measure |
Cognitive Training
n=19 Participants
As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested in this study. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.
|
Attention Control
n=17 Participants
Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.
Computerized Crossword Puzzles: The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.
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|---|---|---|
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Change in Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Abilities Between Baseline and 1 Week Post-intervention
|
27.9 score on a scale
Standard Deviation 5.7
|
28.1 score on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline and within 1 week post-interventionPerceived Cognitive Impairment (PCI) measured using 8-item, 5-point Likert scales with range from 8-40. The Cognitive Abilities Scale items target positive self-assessments of cognitive functioning with higher scores indicating better cognitive ability. The Cognitive Concerns Scale items are worded negatively and express concerns in the same area with higher scores indicating more cognitive concerns. Outcomes are controlled for the baseline assessment.
Outcome measures
| Measure |
Cognitive Training
n=19 Participants
As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested in this study. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.
|
Attention Control
n=17 Participants
Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.
Computerized Crossword Puzzles: The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.
|
|---|---|---|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Concerns Between Baseline and 1 Week Post-intervention
|
19.9 score on a scale
Standard Deviation 6.7
|
19.9 score on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline and within 1 week post-interventionWork ability was assessed by one item from the WAI. This item assessed current work ability on a Likert scale from 1 (cannot work at all) to 10 (work ability at its best) with higher scores indicating better work ability. Outcomes are controlled for the baseline assessment.
Outcome measures
| Measure |
Cognitive Training
n=19 Participants
As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested in this study. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.
|
Attention Control
n=17 Participants
Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.
Computerized Crossword Puzzles: The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.
|
|---|---|---|
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Change in Work Ability Index (WAI) Between Baseline and 1 Week Post-intervention
|
7.8 score on a scale
Standard Deviation 1.9
|
7.2 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline and within 1 week post-interventionGeneral Health Perception and Quality of life (general mental health) was measured using The MOS-SF-36 with the general perceptions of health status subscale used to measure general health perceptions (5 items), on a 5-point Likert scale (total range of 5-25), with higher scores indicating positive perceptions of general health and general mental health. Outcomes are controlled for the baseline assessment.
Outcome measures
| Measure |
Cognitive Training
n=19 Participants
As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested in this study. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.
|
Attention Control
n=17 Participants
Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.
Computerized Crossword Puzzles: The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.
|
|---|---|---|
|
Change in Medical Outcomes Study-Short-Form Health Survey (MOS SF-36) General Perceptions of Health Between Baseline and 1 Week Post-intervention
|
18.2 score on a scale
Standard Deviation 4.6
|
18.9 score on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline and within 1 week post-interventionGeneral Health Perception and Quality of life (general mental health) was measured using The MOS-SF-36 with the, changes in general health perception (1-item), on a 5-point Likert scale (total range of 1-5), with higher scores indicating positive perceptions of general health and general mental health. Outcomes are controlled for the baseline assessment.
Outcome measures
| Measure |
Cognitive Training
n=19 Participants
As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested in this study. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.
|
Attention Control
n=17 Participants
Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.
Computerized Crossword Puzzles: The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.
|
|---|---|---|
|
Change in Medical Outcomes Study-Short-Form Health Survey (MOS SF-36) Perceived Change in Health Between Baseline and 1 Week Post-intervention
|
2.4 score on a scale
Standard Deviation 0.9
|
2.2 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline and within 1 week post-interventionGeneral Health Perception and Quality of life (general mental health) was measured using The MOS-SF-36 with the general mental health (5-items), on a 5-point Likert scale (total range of 5-25), with higher scores indicating positive perceptions of general health and general mental health. Outcomes are controlled for the baseline assessment.
Outcome measures
| Measure |
Cognitive Training
n=19 Participants
As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested in this study. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.
|
Attention Control
n=17 Participants
Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.
Computerized Crossword Puzzles: The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.
|
|---|---|---|
|
Change in Medical Outcomes Study-Short-Form Health Survey (MOS SF-36) General Mental Health Between Baseline and 1 Week Post-intervention
|
5.3 score on a scale
Standard Deviation 1.0
|
5.4 score on a scale
Standard Deviation 1.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and within 1 week post-interventionMeasure of learning and episodic memory. List of 15 words given and asked to recall, score range from 0-75. Higher scores indicate better outcomes. Outcomes are controlled for the baseline assessment.
Outcome measures
| Measure |
Cognitive Training
n=19 Participants
As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested in this study. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.
|
Attention Control
n=17 Participants
Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.
Computerized Crossword Puzzles: The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.
|
|---|---|---|
|
Change in Rey Auditory Verbal Learning Test (Rey AVLT) Total Between Baseline and 1 Week Post-intervention
|
53.8 score on a scale
Standard Deviation 6.8
|
56.7 score on a scale
Standard Deviation 8.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and within 1 week post-interventionMeasure of delayed memory. List of 15 words given and asked to recall at delayed timeframe, score range from 0-15. Higher scores indicate better outcomes. Outcomes are controlled for the baseline assessment.
Outcome measures
| Measure |
Cognitive Training
n=19 Participants
As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested in this study. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.
|
Attention Control
n=17 Participants
Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.
Computerized Crossword Puzzles: The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.
|
|---|---|---|
|
Change in Rey Auditory Verbal Learning Test (Rey AVLT) Delayed Between Baseline and 1 Week Post-intervention
|
9.8 score on a scale
Standard Deviation 2.8
|
12.3 score on a scale
Standard Deviation 2.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and within 1 week post-interventionMeasure of immediate memory. 14-item test with score range from 0-12. Higher scores indicate better outcomes. Outcomes are controlled for the baseline assessment.
Outcome measures
| Measure |
Cognitive Training
n=19 Participants
As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested in this study. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.
|
Attention Control
n=17 Participants
Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.
Computerized Crossword Puzzles: The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.
|
|---|---|---|
|
Change in Rivermead Behavioral Paragraph Recall Test Between Baseline and 1 Week Post-intervention
|
7.4 score on a scale
Standard Deviation 3.3
|
8.3 score on a scale
Standard Deviation 3.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and within 1 week post-interventionMeasure of delayed memory. 14-item test with score range from 0-12. Higher scores indicate better outcomes. Outcomes are controlled for the baseline assessment.
Outcome measures
| Measure |
Cognitive Training
n=19 Participants
As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested in this study. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.
|
Attention Control
n=17 Participants
Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.
Computerized Crossword Puzzles: The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.
|
|---|---|---|
|
Change in Rivermead Behavioral Paragraph Recall Test -Delayed Between Baseline and 1 Week Post-intervention
|
6.7 score on a scale
Standard Deviation 3.3
|
7.9 score on a scale
Standard Deviation 3.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and within 1 week post-interventionMeasure of speed of processing. 90 seconds to pair numbers and figures, score range 0-110. Higher scores indicate better outcomes. Outcomes are controlled for the baseline assessment.
Outcome measures
| Measure |
Cognitive Training
n=19 Participants
As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested in this study. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.
|
Attention Control
n=17 Participants
Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.
Computerized Crossword Puzzles: The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.
|
|---|---|---|
|
Change in Symbol Digit Modalities Test [SDMT], Oral Response Version Between Baseline and 1 Week Post-intervention
|
53.6 score on a scale
Standard Deviation 9.3
|
58.1 score on a scale
Standard Deviation 7.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and within 1 week post-interventionMeasures attention and working memory by asking participants to Repeat a number sequence, The total score being calculated by adding the correct responses from both the "Digits Forward" and "Digits Backward" sections, with each correct sequence contributing one point. Scores range from 0 to 32. Higher scores indicate better outcomes. Outcomes are controlled for the baseline assessment.
Outcome measures
| Measure |
Cognitive Training
n=19 Participants
As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested in this study. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.
|
Attention Control
n=17 Participants
Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.
Computerized Crossword Puzzles: The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.
|
|---|---|---|
|
Change in Digit Span, Total Raw Score From the WAIS-III Between Baseline and 1 Week Post-intervention
|
17.3 score on a scale
Standard Deviation 3.0
|
17.7 score on a scale
Standard Deviation 3.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and within 1 week post-interventionMeasure of verbal/executive functioning. Provide a spontaneous list of words within 60 seconds, score range from 0-60. Higher scores indicate better outcomes. Outcomes are controlled for the baseline assessment.
Outcome measures
| Measure |
Cognitive Training
n=19 Participants
As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested in this study. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.
|
Attention Control
n=17 Participants
Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.
Computerized Crossword Puzzles: The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.
|
|---|---|---|
|
Change in Controlled Oral Word Association (COWA) Between Baseline and 1 Week Post-intervention
|
43.0 score on a scale
Standard Deviation 9.8
|
46.4 score on a scale
Standard Deviation 9.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and within 1 week post-interventionPlasma levels of BDNF were measured in duplicate by ELISA (catalog number DBD00; R\&D Systems, Minneapolis, MN). The minimum detectable level of BDNF in this assay is 20 pg/ ml, and the within-assay variation is 4.2% at 1339 pg/ml. Higher levels indicate higher concentrations of BDNF (reported in pg/ml). Outcomes are controlled for the baseline assessment.
Outcome measures
| Measure |
Cognitive Training
n=19 Participants
As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested in this study. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.
|
Attention Control
n=17 Participants
Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.
Computerized Crossword Puzzles: The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.
|
|---|---|---|
|
Change in Serum Levels of Brain-Derived Neurotropic Factor (BDNF) Between Baseline and 1 Week Post-intervention
|
22,404 pg/ml
Standard Deviation 7287.8
|
24,920 pg/ml
Standard Deviation 6277.4
|
Adverse Events
Cognitive Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place