Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol Using Computer-based Training
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Change in Cognitive Performance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Cognitive Training Low Dose
Cognitive training completed for 8 sessions
Intervention: COGENT (Behavioral)
Cognitive Training High Dose
Cognitive training completed for 16 sessions
Intervention: COGENT (Behavioral)
Repeat Assessment
Outcomes
Primary Outcomes
Change in Cognitive Performance
Time Frame: Baseline, Week 4
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).
Secondary Outcomes
- Symptoms of Depression(Baseline, Week 4)
- PTSD Symptoms(Baseline, Week 4)
- Emotion Regulation(Baseline, Week 4)
- Disability(Baseline, Week 4)
- Suicide Cognitions(Baseline, Week 4)
- Alcohol Use(Baseline, Week 4)
- Drug Abuse(Baseline, Week 4)
- Insomnia(Baseline, Week 4)
- Symptoms of Depression(Baseline, Week 4)
- PTSD Symptoms(Baseline, Week 4)
- Change in Reading Span Blood Oxygen Level Dependent (BOLD) Response(Baseline, Week 4)
- Change in Emotional Working Memory Blood Oxygen Level Dependent (BOLD) Response(Week 4)
- Change in Neuropsychological Performance(Baseline, Week 4)
- Anxiety Symptoms(Baseline, Week 4)
- Change Repetitive Negative Thinking (RNT)(Baseline, Week 4)
- Self-reported Attention Attention(Baseline, Week 4)
- Emotion Regulation(Baseline, Week 4)
- Disability(Baseline, Week 4)
- Suicide Cognitions(Baseline, Week 4)
- Alcohol Use(Baseline, Week 4)
- Drug Abuse(Baseline, Week 4)
- Insomnia(Baseline, Week 4)
- Change in Mood and Emotions: Negative Affect(Baseline, Week 4)
- Change in Mood and Emotion: Positive Affect(Baseline, 4 weeks)
Investigators
Jessica Bomyea
Assistant Professor
University of California, San Diego