Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06420557

Unconscious Reduction of Fear Through Decoded Neuro-Reinforcement

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
University of California, Los Angeles · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

This application investigates the efficacy of a novel method of neuro-reinforcement based on decoded fMRI activity to reduce fear responses in individuals with phobias (e.g., spiders, snakes). This method works unconsciously in the brain, without the need for participants to endure repeated conscious exposures to their feared stimuli. Fear-related disorders such as specific phobia, post-traumatic stress disorder (PTSD), and other anxiety disorders present a major challenge, as effective treatment options usually involve repeated exposures to feared stimuli, leading to high levels of distress, fear, and panic that can motivate premature treatment termination. Consequently, there is an unmet need for treatment that minimizes subjective discomfort and attrition in order to maximize efficacy. Recent developments in computational neuroimaging have enabled a method that can deliver unconscious exposure to feared stimuli, resulting in effective fear reduction while bypassing a primary cause of treatment attrition. Because this treatment method happens unconsciously in the brain, changes in behavior outcomes are potentially more likely to generalize to different contexts, thereby overcoming a limitation of traditional treatments.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALUnconscious Neuro-reinforcementIndividuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 1 session of neuro-reinforcement.
BEHAVIORALUnconscious Neuro-reinforcementIndividuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 3 sessions of neuro-reinforcement.
BEHAVIORALUnconscious Neuro-reinforcementIndividuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 5 sessions of neuro-reinforcement.

Timeline

Start date
2024-09-09
Primary completion
2026-09-30
Completion
2026-09-30
First posted
2024-05-20
Last updated
2025-10-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06420557. Inclusion in this directory is not an endorsement.