Unconscious Reduction of Fear Through Decoded Neuro-Reinforcement

NCT06420557 | Recruiting

• 2 other identifiers: 23-001604R33MH135002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Phobia

Keywords

unconscious fear extinction; anxiety disorders; decoded neuro-reinforcement

Outcome Measures

Primary Outcomes (2)

• Change in Amygdala Reactivity

  The neural measure of difference in amygdala reactivity (measured by fMRI) to target phobic animals compared to control phobic animals from pre-treatment to post-treatment. Lower numbers (i.e. more negative numbers) indicate greater amygdala decrease and and better outcomes.

  14 days (measured at pre-treatment and 2 weeks)

• Subjective Fear Post-treatment Minus Pre-treatment

  Subjective Fear Ratings of images of targeted phobic stimuli Minimum score of 0, Maximum score of 180, higher scores mean worse outcome.

  14 days (measured at pre-treatment and 2 weeks)

Secondary Outcomes (10)

• Skin Conductance Response: Physiological Arousal Post-treatment Minus Pre-treatment

  14 days (measured at pre-treatment and 2 weeks)

• Fear Survey Schedule

  14 days (measured at pre-treatment and 2 weeks)

• Stroop Task Post-treatment Minus Pre-treatment

  14 days (measured at pre-treatment and 2 weeks)

• Approach/Avoidance Behavior in VR Post-treatment Minus Pre-treatment

  14 days (measured at pre-treatment and 2 weeks)

• Subjective Fear Ratings in Virtual Reality (VR) Post-treatment Minus Pre-treatment

  14 days (measured at pre-treatment and 2 weeks)

Study Arms (3)

1 Session

EXPERIMENTAL

1 neuro-reinforcement session

Behavioral: Unconscious Neuro-reinforcement

3 Sessions

EXPERIMENTAL

3 neuro-reinforcement sessions

Behavioral: Unconscious Neuro-reinforcement

5 sessions

EXPERIMENTAL

5 neuro-reinforcement sessions

Behavioral: Unconscious Neuro-reinforcement

Interventions

Unconscious Neuro-reinforcement BEHAVIORAL

Individuals 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.

1 Session

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual has normal or corrected to normal vision
• Individual has normal or corrected to normal hearing
• Individual is competent to understand informed consent
• Individual must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for specific phobias, animal subtype

You may not qualify if:

• Individual is unable to fill in consent form correctly
• Individual is unable to respond adequately to screening questions
• Individual is unable to maintain focus or to sit during assessment
• 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
• Participant receives an elevated score on the PHQ-9
• Individual does not present with more than one object of specific phobia
• Individual can touch the phobic object category during the pre-treatment Behavioral Approach Test without presenting significant distress
• Individual is currently prescribed psychotropic medication

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Phobic Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Michelle G Craske, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel J Fiol, B.A.

CONTACT

7252228834; gfiol@psych.ucla.edu

Kainoa R MacDonald, B.A.

CONTACT

macdonald@psych.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

US (1)