Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol
Primary Purpose
Anxiety Disorders, Depression, Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COGENT
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders
Eligibility Criteria
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
Sites / Locations
- UC San Diego
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Cognitive Training Low Dose
Cognitive Training High Dose
Repeat Assessment
Arm Description
Cognitive training completed for 8 sessions
Cognitive training completed for 16 sessions
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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).
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 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.
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.
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.
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.
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.
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.
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.
Mood and Emotions
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.
Full Information
NCT ID
NCT04912089
First Posted
May 28, 2021
Last Updated
August 21, 2023
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT04912089
Brief Title
Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol
Official Title
Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol Using Computer-based Training
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depression, Posttraumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Training Low Dose
Arm Type
Experimental
Arm Description
Cognitive training completed for 8 sessions
Arm Title
Cognitive Training High Dose
Arm Type
Experimental
Arm Description
Cognitive training completed for 16 sessions
Arm Title
Repeat Assessment
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
COGENT
Intervention Description
COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
Primary Outcome Measure Information:
Title
Change in cognitive performance
Description
Span Working Memory Score. Scores are calculated based on memory accuracy total points across all trials, with higher scores indicating better performance.
Time Frame
Baseline, Week 4
Secondary Outcome Measure Information:
Title
Reading Span Blood Oxygen Level Dependent (BOLD) Response
Description
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
Title
Emotional Working Memory Blood Oxygen Level Dependent (BOLD) Response
Description
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
Title
Neuropsychological Performance
Description
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.
Time Frame
Baseline, Week 4
Title
Anxiety Symptoms
Description
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
Title
Symptoms of Depression
Description
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
Title
PTSD Symptoms
Description
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
Title
Repetitive Negative Thinking (RNT)
Description
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).
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
Title
Self-reported attention Attention
Description
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
Title
Emotion Regulation
Description
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.
Time Frame
Baseline, Week 4
Title
Disability
Description
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
Title
Suicide Cognitions
Description
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
Title
Alcohol Use
Description
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
Title
Drug Abuse
Description
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
Title
Insomnia
Description
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
Title
Mood and Emotions
Description
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.
Time Frame
Baseline, Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UC San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol
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