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Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol

Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol Using Computer-based Training

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04912089
Enrollment
73
Registered
2021-06-03
Start date
2021-10-15
Completion date
2023-06-30
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Depression, Posttraumatic Stress Disorder

Brief summary

The proposed project aims to test the cognitive and neural effects of a cognitive training in a sample of individuals seeking treatment for anxiety, depression, or traumatic stress symptoms. Participants will be randomly assigned to a high dose, low dose, or assessment only condition. Participants will be compared on cognitive performance and brain response during cognitive tasks from baseline to post-treatment.

Detailed description

Mood, anxiety, and traumatic stress disorders are common psychiatric conditions - affecting over 40 million U.S. adults - and are leading causes of disability worldwide. People with these conditions are commonly plagued by difficulty controlling distressing personal thoughts and memories, collectively referred to as repetitive negative thinking symptoms. Models suggest that repetitive negative thinking is driven by executive functioning deficits, such that cognitive resources are insufficient to downregulate unwanted thoughts. Executive functioning deficits could be a promising treatment target but are not typically addressed with existing interventions. The long-term goal advanced by this project is to develop effective, mechanistic cognitive training programs that can improve cognition and reduce symptoms associated with mood, anxiety, and traumatic stress disorders. The objectives of this proposal are first to determine the optimal dose of a cognitive training program designed to improve executive functioning in this population using behavioral and neural outcomes. The central hypothesis is that repeated training exercises will enhance executive functioning and will lead to a reduction of repetitive negative thinking in mood, anxiety, and traumatic stress disorders. The project will randomize participants with depression, anxiety, and/or traumatic stress disorders to one of two doses of cognitive training or a no-treatment control condition. The investigators will examine executive functioning change with cognitive task performance and functional neuroimaging assessments.

Interventions

BEHAVIORALCOGENT

COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.

Sponsors

University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* age 21-55 * fluent in English * diagnosis of mood, anxiety, or traumatic stress disorder * clinically elevated repetitive negative thinking * outpatient status * 6-week stability if taking selective serotonin reuptake inhibitor (SSRI) medications

Exclusion criteria

* past year diagnosis of severe alcohol or moderate or greater substance use disorder * lifetime history of psychotic or bipolar I disorder * acute suicidality necessitating immediate clinical intervention * neurodegenerative or neurodevelopmental disorders * history of moderate or severe traumatic brain injury or other known neurological condition * sensory deficits that would preclude completing tasks * conditions unsafe for completing MRI scanning (e.g., metal in body) * currently receiving psychosocial treatment * currently receiving psychiatric pharmacotherapy, except SSRIs

Design outcomes

Primary

MeasureTime frameDescription
Change in Cognitive PerformanceBaseline, Week 4Span Working Memory Score. Scores are calculated based on memory accuracy total points across all trials, with higher scores indicating better performance (0-81 range).

Secondary

MeasureTime frameDescription
Change in Emotional Working Memory Blood Oxygen Level Dependent (BOLD) ResponseWeek 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.
Change in Neuropsychological PerformanceBaseline, 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).
Anxiety SymptomsBaseline, 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.
Symptoms of DepressionBaseline, 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.
PTSD SymptomsBaseline, 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.
Change Repetitive Negative Thinking (RNT)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.
Self-reported Attention AttentionBaseline, 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.
Change in Reading Span Blood Oxygen Level Dependent (BOLD) ResponseBaseline, 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.
DisabilityBaseline, 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.
Suicide CognitionsBaseline, 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.
Alcohol UseBaseline, 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.
Drug AbuseBaseline, 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.
InsomniaBaseline, 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.
Change in Mood and Emotions: Negative AffectBaseline, 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).
Change in Mood and Emotion: Positive AffectBaseline, 4 weeksChanges 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).
Emotion RegulationBaseline, 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
24
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.
24
Repeat Assessment
Repeated assessment only
24
Total72

Baseline characteristics

CharacteristicCognitive Training Low DoseCognitive Training High DoseRepeat AssessmentTotal
Age, Continuous31.8 years
STANDARD_DEVIATION 8.05
33.12 years
STANDARD_DEVIATION 8.93
31.59 years
STANDARD_DEVIATION 7.79
31.84 years
STANDARD_DEVIATION 8.15
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
5 Participants1 Participants3 Participants9 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
5 Participants2 Participants5 Participants12 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants5 Participants2 Participants7 Participants
Race (NIH/OMB)
White
13 Participants16 Participants14 Participants43 Participants
Region of Enrollment
United States
24 Participants24 Participants24 Participants72 Participants
Sex/Gender, Customized
Female
18 Participants17 Participants21 Participants56 Participants
Sex/Gender, Customized
Male
5 Participants6 Participants3 Participants14 Participants
Sex/Gender, Customized
Missing
0 Participants1 Participants0 Participants1 Participants
Sex/Gender, Customized
Other
1 Participants0 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 240 / 24
other
Total, other adverse events
0 / 240 / 240 / 24
serious
Total, serious adverse events
0 / 240 / 240 / 24

Outcome results

Primary

Change in Cognitive Performance

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).

Time frame: Baseline, Week 4

Population: Sample reflects missing data for high and repeat assessment groups

ArmMeasureValue (MEAN)Dispersion
Cognitive Training Low DoseChange in Cognitive Performance4.92 score on a scaleStandard Deviation 8.07
Cognitive Training High DoseChange in Cognitive Performance8.18 score on a scaleStandard Deviation 14.03
Repeat AssessmentChange in Cognitive Performance.27 score on a scaleStandard Deviation 10.58
Secondary

Alcohol Use

Change 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.

Time frame: Baseline, Week 4

ArmMeasureValue (MEAN)Dispersion
Cognitive Training Low DoseAlcohol Use.17 score on a scaleStandard Deviation 1.76
Cognitive Training High DoseAlcohol Use-.17 score on a scaleStandard Deviation 1.47
Repeat AssessmentAlcohol Use.14 score on a scaleStandard Deviation 2.17
Secondary

Anxiety Symptoms

Change 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.

Time frame: Baseline, Week 4

ArmMeasureValue (MEAN)Dispersion
Cognitive Training Low DoseAnxiety Symptoms-1.21 score on a scaleStandard Deviation 4.59
Cognitive Training High DoseAnxiety Symptoms-4.28 score on a scaleStandard Deviation 6.59
Repeat AssessmentAnxiety Symptoms-1.14 score on a scaleStandard Deviation 5.78
Secondary

Change in Emotional Working Memory Blood Oxygen Level Dependent (BOLD) Response

Functional 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.

Time frame: Week 4

ArmMeasureValue (MEAN)Dispersion
Cognitive Training Low DoseChange in Emotional Working Memory Blood Oxygen Level Dependent (BOLD) Response.21 percent BOLD signal change ROI1Standard Deviation 1.26
Cognitive Training High DoseChange in Emotional Working Memory Blood Oxygen Level Dependent (BOLD) Response.58 percent BOLD signal change ROI1Standard Deviation 1.28
Repeat AssessmentChange in Emotional Working Memory Blood Oxygen Level Dependent (BOLD) Response-1.56 percent BOLD signal change ROI1Standard Deviation 1.09
Secondary

Change in Mood and Emotion: Positive Affect

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).

Time frame: Baseline, 4 weeks

Population: Reflects missing data

ArmMeasureValue (MEAN)Dispersion
Cognitive Training Low DoseChange in Mood and Emotion: Positive Affect1.25 score on a scaleStandard Deviation 13.25
Cognitive Training High DoseChange in Mood and Emotion: Positive Affect2.55 score on a scaleStandard Deviation 12.12
Repeat AssessmentChange in Mood and Emotion: Positive Affect.32 score on a scaleStandard Deviation 10.33
Secondary

Change in Mood and Emotions: Negative Affect

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).

Time frame: Baseline, Week 4

ArmMeasureValue (MEAN)Dispersion
Cognitive Training Low DoseChange in Mood and Emotions: Negative Affect-3.38 score on a scaleStandard Deviation 7.14
Cognitive Training High DoseChange in Mood and Emotions: Negative Affect-5.06 score on a scaleStandard Deviation 9.77
Repeat AssessmentChange in Mood and Emotions: Negative Affect-.38 score on a scaleStandard Deviation 5.07
Secondary

Change in Neuropsychological Performance

Change 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).

Time frame: Baseline, Week 4

ArmMeasureValue (MEAN)Dispersion
Cognitive Training Low DoseChange in Neuropsychological Performance4.35 T scoreStandard Deviation 6.79
Cognitive Training High DoseChange in Neuropsychological Performance7.94 T scoreStandard Deviation 6.91
Repeat AssessmentChange in Neuropsychological Performance1.37 T scoreStandard Deviation 7.67
Secondary

Change in Reading Span Blood Oxygen Level Dependent (BOLD) Response

Functional 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.

Time frame: Baseline, Week 4

ArmMeasureValue (MEAN)Dispersion
Cognitive Training Low DoseChange in Reading Span Blood Oxygen Level Dependent (BOLD) Response-2.90 percent BOLD signal change ROI1Standard Deviation 6.16
Cognitive Training High DoseChange in Reading Span Blood Oxygen Level Dependent (BOLD) Response-2.16 percent BOLD signal change ROI1Standard Deviation 6.62
Repeat AssessmentChange in Reading Span Blood Oxygen Level Dependent (BOLD) Response2.46 percent BOLD signal change ROI1Standard Deviation 3.19
Secondary

Change Repetitive Negative Thinking (RNT)

Change 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.

Time frame: Baseline, Week 4

ArmMeasureValue (MEAN)Dispersion
Cognitive Training Low DoseChange Repetitive Negative Thinking (RNT)-.09 Z scoreStandard Deviation 0.67
Cognitive Training High DoseChange Repetitive Negative Thinking (RNT)-.12 Z scoreStandard Deviation 0.72
Repeat AssessmentChange Repetitive Negative Thinking (RNT).01 Z scoreStandard Deviation 0.8
Secondary

Disability

Change 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.

Time frame: Baseline, Week 4

ArmMeasureValue (MEAN)Dispersion
Cognitive Training Low DoseDisability-1.66 score on a scaleStandard Deviation 2.21
Cognitive Training High DoseDisability-1.42 score on a scaleStandard Deviation 2.14
Repeat AssessmentDisability-.32 score on a scaleStandard Deviation 1.56
Secondary

Drug Abuse

Change 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.

Time frame: Baseline, Week 4

ArmMeasureValue (MEAN)Dispersion
Cognitive Training Low DoseDrug Abuse.00 score on a scaleStandard Deviation 0.78
Cognitive Training High DoseDrug Abuse.11 score on a scaleStandard Deviation 0.76
Repeat AssessmentDrug Abuse-.09 score on a scaleStandard Deviation 0.81
Secondary

Emotion Regulation

Change 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).

Time frame: Baseline, Week 4

ArmMeasureValue (MEAN)Dispersion
Cognitive Training Low DoseEmotion Regulation-1.04 score on a scaleStandard Deviation 6.96
Cognitive Training High DoseEmotion Regulation-1.06 score on a scaleStandard Deviation 8.35
Repeat AssessmentEmotion Regulation.59 score on a scaleStandard Deviation 7.42
Secondary

Insomnia

Changes 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.

Time frame: Baseline, Week 4

ArmMeasureValue (MEAN)Dispersion
Cognitive Training Low DoseInsomnia-.21 score on a scaleStandard Deviation 4.38
Cognitive Training High DoseInsomnia-3.06 score on a scaleStandard Deviation 5.67
Repeat AssessmentInsomnia-2.09 score on a scaleStandard Deviation 4.64
Secondary

PTSD Symptoms

Change 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.

Time frame: Baseline, Week 4

ArmMeasureValue (MEAN)Dispersion
Cognitive Training Low DosePTSD Symptoms-6.46 score on a scaleStandard Deviation 14.82
Cognitive Training High DosePTSD Symptoms-4.39 score on a scaleStandard Deviation 15.32
Repeat AssessmentPTSD Symptoms-7.91 score on a scaleStandard Deviation 10.99
Secondary

Self-reported Attention Attention

Change 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.

Time frame: Baseline, Week 4

ArmMeasureValue (MEAN)Dispersion
Cognitive Training Low DoseSelf-reported Attention Attention-.04 score on a scaleStandard Deviation 5.05
Cognitive Training High DoseSelf-reported Attention Attention1.89 score on a scaleStandard Deviation 5.3
Repeat AssessmentSelf-reported Attention Attention1.05 score on a scaleStandard Deviation 3.8
Secondary

Suicide Cognitions

Change 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.

Time frame: Baseline, Week 4

ArmMeasureValue (MEAN)Dispersion
Cognitive Training Low DoseSuicide Cognitions-2.79 score on a scaleStandard Deviation 7.67
Cognitive Training High DoseSuicide Cognitions-5.44 score on a scaleStandard Deviation 10.85
Repeat AssessmentSuicide Cognitions-5.18 score on a scaleStandard Deviation 6.65
Secondary

Symptoms of Depression

Change 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.

Time frame: Baseline, Week 4

ArmMeasureValue (MEAN)Dispersion
Cognitive Training Low DoseSymptoms of Depression-2.46 score on a scaleStandard Deviation 4.77
Cognitive Training High DoseSymptoms of Depression-1.56 score on a scaleStandard Deviation 5.92
Repeat AssessmentSymptoms of Depression-1.48 score on a scaleStandard Deviation 3.31

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026