Trial Outcomes & Findings for Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (NCT NCT04912089)
NCT ID: NCT04912089
Last Updated: 2025-07-23
Results Overview
Span Working Memory Score. Scores are calculated based on memory accuracy total points across all trials, with higher scores indicating better performance (0-81 range).
COMPLETED
NA
73 participants
Baseline, Week 4
2025-07-23
Participant Flow
Participant milestones
| Measure |
Cognitive Training Low Dose
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
Repeated assessment only
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
18
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol
Baseline characteristics by cohort
| Measure |
Cognitive Training Low Dose
n=24 Participants
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
n=24 Participants
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
n=24 Participants
Repeated assessment only
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.8 years
STANDARD_DEVIATION 8.05 • n=5 Participants
|
33.12 years
STANDARD_DEVIATION 8.93 • n=7 Participants
|
31.59 years
STANDARD_DEVIATION 7.79 • n=5 Participants
|
31.84 years
STANDARD_DEVIATION 8.15 • n=4 Participants
|
|
Sex/Gender, Customized
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: Sample reflects missing data for high and repeat assessment groups
Span Working Memory Score. Scores are calculated based on memory accuracy total points across all trials, with higher scores indicating better performance (0-81 range).
Outcome measures
| Measure |
Cognitive Training Low Dose
n=24 Participants
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
n=17 Participants
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
n=22 Participants
Repeated assessment only
|
|---|---|---|---|
|
Change in Cognitive Performance
|
4.92 score on a scale
Standard Deviation 8.07
|
8.18 score on a scale
Standard Deviation 14.03
|
.27 score on a scale
Standard Deviation 10.58
|
SECONDARY outcome
Timeframe: Baseline, Week 4Functional Magnetic Resonance Imaging (fMRI) Reading span working memory capacity task while undergoing functional MRI. Neural activation to task condition is measured using % signal change (0-100) with higher scores indicating greater activation.
Outcome measures
| Measure |
Cognitive Training Low Dose
n=21 Participants
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
n=18 Participants
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
n=18 Participants
Repeated assessment only
|
|---|---|---|---|
|
Change in Reading Span Blood Oxygen Level Dependent (BOLD) Response
|
-2.90 percent BOLD signal change ROI1
Standard Deviation 6.16
|
-2.16 percent BOLD signal change ROI1
Standard Deviation 6.62
|
2.46 percent BOLD signal change ROI1
Standard Deviation 3.19
|
SECONDARY outcome
Timeframe: Week 4Functional Magnetic Resonance Imaging (fMRI) emotional working memory capacity task while undergoing functional MRI. Neural activation to task condition is measured using % signal change (0-100) with higher scores indicating greater activation.
Outcome measures
| Measure |
Cognitive Training Low Dose
n=22 Participants
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
n=16 Participants
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
n=16 Participants
Repeated assessment only
|
|---|---|---|---|
|
Change in Emotional Working Memory Blood Oxygen Level Dependent (BOLD) Response
|
.21 percent BOLD signal change ROI1
Standard Deviation 1.26
|
.58 percent BOLD signal change ROI1
Standard Deviation 1.28
|
-1.56 percent BOLD signal change ROI1
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: Baseline, Week 4Change from baseline in neuropsychological performance as measured by the following tests: Flanker Inhibitory Control and Attention Test, Picture Sequence Memory Test, List Sorting Working Memory Test, Oral Reading Recognition Test, Dimensional Change Card Sort Test, Pattern Comparison Processing Speed Test, Matrix Reasoning, Digit Span, Trail Making Test, Digit Symbol Matching, composite score (change in NIH corrected fluid cognition t score) with larger scores reflecting larger gains (1-100 range; T score of 50 is mean with standard deviation of 10).
Outcome measures
| Measure |
Cognitive Training Low Dose
n=23 Participants
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
n=17 Participants
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
n=19 Participants
Repeated assessment only
|
|---|---|---|---|
|
Change in Neuropsychological Performance
|
4.35 T score
Standard Deviation 6.79
|
7.94 T score
Standard Deviation 6.91
|
1.37 T score
Standard Deviation 7.67
|
SECONDARY outcome
Timeframe: Baseline, Week 4Change from baseline in anxiety symptoms as measured by General Anxiety Disorder 7 (GAD-7). The total score ranges from 0-21. With higher scores indicating higher levels of anxiety symptoms.
Outcome measures
| Measure |
Cognitive Training Low Dose
n=24 Participants
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
n=18 Participants
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
n=22 Participants
Repeated assessment only
|
|---|---|---|---|
|
Anxiety Symptoms
|
-1.21 score on a scale
Standard Deviation 4.59
|
-4.28 score on a scale
Standard Deviation 6.59
|
-1.14 score on a scale
Standard Deviation 5.78
|
SECONDARY outcome
Timeframe: Baseline, Week 4Change from baseline in symptoms of depression as measured by the PhenX Depression-Quick Inventory of Depressive Symptoms (QUIDS). The total score ranges from 0-27, with higher scores indicating higher depressive symptoms.
Outcome measures
| Measure |
Cognitive Training Low Dose
n=24 Participants
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
n=18 Participants
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
n=21 Participants
Repeated assessment only
|
|---|---|---|---|
|
Symptoms of Depression
|
-2.46 score on a scale
Standard Deviation 4.77
|
-1.56 score on a scale
Standard Deviation 5.92
|
-1.48 score on a scale
Standard Deviation 3.31
|
SECONDARY outcome
Timeframe: Baseline, Week 4Change from baseline in PTSD symptoms as measured by PTSD Checklist for DSM-5 (PCL-5).The total score ranges from 0-80, with higher scores indicating higher severity.
Outcome measures
| Measure |
Cognitive Training Low Dose
n=24 Participants
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
n=18 Participants
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
n=22 Participants
Repeated assessment only
|
|---|---|---|---|
|
PTSD Symptoms
|
-6.46 score on a scale
Standard Deviation 14.82
|
-4.39 score on a scale
Standard Deviation 15.32
|
-7.91 score on a scale
Standard Deviation 10.99
|
SECONDARY outcome
Timeframe: Baseline, Week 4Change from baseline in RNT as measured by the Ruminative Response Scale (RRS), Penn State Worry Questionnaire (PSWQ), the Repetitive Negative Thinking Questionnaire-10 (RTQ-10) and the Perseverative Thinking Questionnaire (PTQ) composite z score (z score of 0 reflects mean, larger scores reflecting worse symptoms). The total score for the RRS ranges from 22 to 88, with higher scores indicating higher degrees of ruminative symptoms. The total score for the PSWQ ranges from 16 to 80, with higher scores indicating higher worry. The total score for the RTQ-10 ranges from 10 to 50, with higher scores indicating higher repetitive thinking. The total score for the PTQ ranges from 0 to 60, with higher scores indicating higher repetitive negative thinking. Scores of each characteristic of RNT can also be obtained.
Outcome measures
| Measure |
Cognitive Training Low Dose
n=24 Participants
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
n=18 Participants
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
n=22 Participants
Repeated assessment only
|
|---|---|---|---|
|
Change Repetitive Negative Thinking (RNT)
|
-.09 Z score
Standard Deviation .67
|
-.12 Z score
Standard Deviation .72
|
.01 Z score
Standard Deviation .80
|
SECONDARY outcome
Timeframe: Baseline, Week 4Change from baseline in attention focusing and attention shifting as measured by the Attention Control Questionnaire. The total score ranges from 20 to 80, with higher scores indicating higher levels of attention control.
Outcome measures
| Measure |
Cognitive Training Low Dose
n=24 Participants
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
n=18 Participants
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
n=22 Participants
Repeated assessment only
|
|---|---|---|---|
|
Self-reported Attention Attention
|
-.04 score on a scale
Standard Deviation 5.05
|
1.89 score on a scale
Standard Deviation 5.30
|
1.05 score on a scale
Standard Deviation 3.80
|
SECONDARY outcome
Timeframe: Baseline, Week 4Change from baseline in emotion regulation tendencies as measured by the Emotion Regulation Questionnaire (ERQ). Scores are obtained by averaging the scores of two subscales: cognitive reappraisal and expressive suppression. Higher scores indicating higher use of emotion regulation (10 to 70 range).
Outcome measures
| Measure |
Cognitive Training Low Dose
n=24 Participants
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
n=18 Participants
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
n=22 Participants
Repeated assessment only
|
|---|---|---|---|
|
Emotion Regulation
|
-1.04 score on a scale
Standard Deviation 6.96
|
-1.06 score on a scale
Standard Deviation 8.35
|
.59 score on a scale
Standard Deviation 7.42
|
SECONDARY outcome
Timeframe: Baseline, Week 4Change from baseline in disability across six domains, understanding and communicating, getting around, self-care, getting along with people, life activities, and participation in society as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). A simple score for the WHODAS 2.0 ranges from 36-180 with higher scores indicating the degree of functional limitations. An item-response-theory based score can also be obtained by summing the recoded item scores within each of the six domains, summing the domains, and converting the summary score into a metric ranging from 0 to 100, with higher scores indicating higher disability.
Outcome measures
| Measure |
Cognitive Training Low Dose
n=24 Participants
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
n=18 Participants
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
n=22 Participants
Repeated assessment only
|
|---|---|---|---|
|
Disability
|
-1.66 score on a scale
Standard Deviation 2.21
|
-1.42 score on a scale
Standard Deviation 2.14
|
-.32 score on a scale
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: Baseline, Week 4Change from baseline in suicide-related beliefs as measures by the Suicide Cognitions Scale-Revised (SCS-R). The total score ranges from 0 to 64, with higher scores indicating higher severity of suicidal cognitions.
Outcome measures
| Measure |
Cognitive Training Low Dose
n=24 Participants
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
n=18 Participants
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
n=22 Participants
Repeated assessment only
|
|---|---|---|---|
|
Suicide Cognitions
|
-2.79 score on a scale
Standard Deviation 7.67
|
-5.44 score on a scale
Standard Deviation 10.85
|
-5.18 score on a scale
Standard Deviation 6.65
|
SECONDARY outcome
Timeframe: Baseline, Week 4Change from baseline in drinking patterns as measured by the Alcohol Use Disorders Identification Test (AUDIT). The total score ranges from 0 to 40, with higher scores indicating higher risk. Such that 1-7 indicates low risk, 8-12 risky, and 13+ high risk.
Outcome measures
| Measure |
Cognitive Training Low Dose
n=24 Participants
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
n=18 Participants
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
n=22 Participants
Repeated assessment only
|
|---|---|---|---|
|
Alcohol Use
|
.17 score on a scale
Standard Deviation 1.76
|
-.17 score on a scale
Standard Deviation 1.47
|
.14 score on a scale
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: Baseline, Week 4Change from baseline in drug abuse as measured by the Drug Abuse Screening Test (DAST-10). The total score ranges from 0-10, with higher scores indicating higher degree of drug abuse related problems.
Outcome measures
| Measure |
Cognitive Training Low Dose
n=24 Participants
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
n=18 Participants
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
n=22 Participants
Repeated assessment only
|
|---|---|---|---|
|
Drug Abuse
|
.00 score on a scale
Standard Deviation .78
|
.11 score on a scale
Standard Deviation .76
|
-.09 score on a scale
Standard Deviation .81
|
SECONDARY outcome
Timeframe: Baseline, Week 4Changes from baseline in insomnia problems as measured by the Insomnia Severity Index (ISI). The total score ranges 0-21, with higher scores indicating severity of insomnia.
Outcome measures
| Measure |
Cognitive Training Low Dose
n=24 Participants
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
n=18 Participants
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
n=22 Participants
Repeated assessment only
|
|---|---|---|---|
|
Insomnia
|
-.21 score on a scale
Standard Deviation 4.38
|
-3.06 score on a scale
Standard Deviation 5.67
|
-2.09 score on a scale
Standard Deviation 4.64
|
SECONDARY outcome
Timeframe: Baseline, Week 4Changes from baseline in mood and emotions as measured by the Positive and Negative Affect Schedule (PANAS).There are two scores calculated, one for positive affect and one for negative affect. The total score for positive affect ranges from 10 to 50. The total score for negative affect ranges from 11 to 55 (higher is greater emotion on the dimension).
Outcome measures
| Measure |
Cognitive Training Low Dose
n=24 Participants
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
n=18 Participants
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
n=22 Participants
Repeated assessment only
|
|---|---|---|---|
|
Change in Mood and Emotions: Negative Affect
|
-3.38 score on a scale
Standard Deviation 7.14
|
-5.06 score on a scale
Standard Deviation 9.77
|
-.38 score on a scale
Standard Deviation 5.07
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Reflects missing data
Changes from baseline in mood and emotions as measured by the Positive and Negative Affect Schedule (PANAS).There are two scores calculated, one for positive affect and one for negative affect. The total score for positive affect ranges from 10 to 50. The total score for negative affect ranges from 11 to 55 (higher is greater emotion on the dimension).
Outcome measures
| Measure |
Cognitive Training Low Dose
n=24 Participants
Cognitive training completed for 8 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Cognitive Training High Dose
n=18 Participants
Cognitive training completed for 16 sessions
COGENT: COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
|
Repeat Assessment
n=22 Participants
Repeated assessment only
|
|---|---|---|---|
|
Change in Mood and Emotion: Positive Affect
|
1.25 score on a scale
Standard Deviation 13.25
|
2.55 score on a scale
Standard Deviation 12.12
|
.32 score on a scale
Standard Deviation 10.33
|
Adverse Events
Cognitive Training Low Dose
Cognitive Training High Dose
Repeat Assessment
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