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Unconscious Reduction of Fear Through Decoded Neuro-Reinforcement

NCT06420557 · University of California, Los Angeles
In plain English

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About this study
The gold standard treatment for specific phobias is exposure therapy, wherein the individual repeatedly faces the object of their fear. However, for many patients, the level of distress prohibits them from either starting or completing exposure therapy. The objective of this application is to use focal neuro-reinforcement based on decoded fMRI information (from the ventral temporal temporal cortex) to reduce fear responses to feared animal stimuli (e.g., spiders, birds) in individuals with phobias, directly and unconsciously in the brain, without repeatedly consciously exposing participants to their feared stimuli. Because the induced representations are unconscious, participants do not experience negative emotional responses and the procedure is double-blind placebo-controlled, thus providing a level of experimental rigor not afforded to standard psychological therapies. Extending from our pilot data, we are positioned to test the mechanisms and behavioral outcomes of a novel treatment for phobias that at the same time advances our understanding of the role of consciousness in fear responses and their change over time. The specific aims are to: (1) confirm that our method engages the neurobiological target (amygdala reactivity to images of feared animals) in a population of individuals with specific phobias of animals; (2) quantify how changes in amygdala reactivity with neuro-reinforcement mediate changes in behavioral outcomes, as measured by attentional capture, approach/avoidance behavior, or subjective fear ratings, immediately post neuro-reinforcement; (3) assess the longer term effects four weeks after neuro-reinforcement; and (4) explore the impact of three dosage levels of neuro-reinforcement to identify the optimal dosage for future research. If proven effective, the results will inform applications for other fear related disorders, such as posttraumatic stress disorder, social anxiety disorder and panic disorder.
Eligibility criteria
Inclusion Criteria: 1. Individual has normal or corrected to normal vision 2. Individual has normal or corrected to normal hearing 3. Individual is competent to understand informed consent 4. Individual must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for specific phobias, animal subtype Exclusion Criteria: 1. Individual is unable to fill in consent form correctly 2. Individual is unable to respond adequately to screening questions 3. Individual is unable to maintain focus or to sit during assessment 4. Individual has history of: neurological disease or defect (e.g., stroke, traumatic brain injury, schizophrenia or other psychological disorders, or seizures) Individual has vision problems (including cataracts, amblyopia, or glaucoma) Individual presents with: Obsessive Compulsive Disorder, Substance Use Disorder, Bipolar Disorder, Psychosis, neurologic diagnoses or unstable serious medical conditions 5. Participant receives an elevated score on the PHQ-9 6. Individual does not present with more than one object of specific phobia 7. Individual can touch the phobic object category during the pre-treatment Behavioral Approach Test without presenting significant distress 8. Individual is currently prescribed psychotropic medication
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2024-09-09
Estimated completion: 2026-09-30
Last updated: 2025-10-02
Interventions
Behavioral: Unconscious Neuro-reinforcementBehavioral: Unconscious Neuro-reinforcementBehavioral: Unconscious Neuro-reinforcement
Primary outcomes
  • Change in Amygdala Reactivity (14 days (measured at pre-treatment and 2 weeks))
  • Subjective Fear Post-treatment Minus Pre-treatment (14 days (measured at pre-treatment and 2 weeks))
Sponsor
University of California, Los Angeles · other
With: National Institute of Mental Health (NIMH)
Contacts & investigators
ContactGabriel J Fiol, B.A. · contact · gfiol@psych.ucla.edu · 7252228834
ContactKainoa R MacDonald, B.A. · contact · macdonald@psych.ucla.edu
InvestigatorMichelle G Craske, PhD · principal_investigator, University of California, Los Angeles
All locations (1)
University of California, Los AngelesRecruiting
Los Angeles, California, United States