Clinical trial NCT04912089: Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol
Official title: Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol Using Computer-based Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Depression
Posttraumatic Stress Disorder
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 73
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in cognitive performance
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Reading Span Blood Oxygen Level Dependent (BOLD) Response
timeFrame: Baseline, Week 4
measure: Emotional Working Memory Blood Oxygen Level Dependent (BOLD) Response
timeFrame: Week 4
measure: Neuropsychological Performance
timeFrame: Baseline, Week 4
measure: Anxiety Symptoms
timeFrame: Baseline, Week 4
measure: Symptoms of Depression
timeFrame: Baseline, Week 4
measure: PTSD Symptoms
timeFrame: Baseline, Week 4
measure: Repetitive Negative Thinking (RNT)
timeFrame: Baseline, Week 4
measure: Self-reported attention Attention
timeFrame: Baseline, Week 4
measure: Emotion Regulation
timeFrame: Baseline, Week 4
measure: Disability
timeFrame: Baseline, Week 4
measure: Suicide Cognitions
timeFrame: Baseline, Week 4
measure: Alcohol Use
timeFrame: Baseline, Week 4
measure: Drug Abuse
timeFrame: Baseline, Week 4
measure: Insomnia
timeFrame: Baseline, Week 4
measure: Mood and Emotions
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UC San Diego
state: California
Study officials:
References: