Clinical trial NCT06273527: Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33)
Official title: Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Anxiety Disorders
Depression
Post Traumatic Stress Disorder
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 128
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 one of two groups. Group 1 will receive a computer-based program that is designed as a cognitive training intervention and Group 2 will receive a similar computer-based exercise that researchers think will be less effective in training thinking skills (also known as a control or sham 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 is to evaluate the cognitive effects of the optimized computer-based cognitive training intervention relative to a sham training program (ST). The central hypothesis is that the cognitive training intervention 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 a cognitive training intervention program or a sham training program. 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)
* current pregnancy
* currently receiving psychosocial treatment
* currently receiving psychiatric pharmacotherapy, except SSRIs

Primary outcomes:
measure: Change in cognitive performance
timeFrame: Baseline, Week 4, Week 8, Week 16
Secondary outcomes:
measure: Reading Span Blood Oxygen Level Dependent (BOLD) Response
timeFrame: Baseline, Week 4
measure: Neuropsychological Performance
timeFrame: Baseline, Week 4, Week 8, Week 16
measure: Repetitive Negative Thinking (RNT)
timeFrame: Baseline, Week 4,Week 8, Week 16
Other outcomes:
measure: Disability
timeFrame: Baseline, Week 4,Week 8, Week 16
measure: Suicide Cognitions
timeFrame: Baseline, Week 4,Week 8, Week 16
measure: Mood and Emotions
timeFrame: Baseline, Week 4,Week 8, Week 16
measure: Self-reported attention
timeFrame: Baseline, Week 4,Week 8, Week 16
measure: Anxiety Symptoms
timeFrame: Baseline, Week 4, Week 8, Week 16
measure: Symptoms of Depression
timeFrame: Baseline, Week 4, Week 8, Week 16
measure: PTSD Symptoms
timeFrame: Baseline, Week 4, Week 8, Week 16
Locations:
city: San Diego
country: United States
facility: UC San Diego
state: California
Study officials:
References: