Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: COGENT, Sham Program.
- Who it may be relevant to
- Registry conditions: Anxiety Disorders, Depression, Post Traumatic Stress Disorder. Basic parameters: 21 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol
Overview
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.
Interventions
- Behavioral COGENT
COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task. - Other Sham Program
The Sham Program will be a similar task which researchers think will be less effective in training thinking skills.
Primary outcome measures
- Change in cognitive performance [Time frame: Baseline, Week 4, Week 8, Week 16]
Secondary outcome measures (3)
- Reading Span Blood Oxygen Level Dependent (BOLD) Response [Time frame: Baseline, Week 4]
- Neuropsychological Performance [Time frame: Baseline, Week 4, Week 8, Week 16]
- Repetitive Negative Thinking (RNT) [Time frame: Baseline, Week 4,Week 8, Week 16]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UC San Diego — San Diego
Identifiers
NCT: NCT06273527 · 808681