PhobiaDecNefNCT06420557
Unconscious Reduction of Fear Through Decoded Neuro-Reinforcement
A study testing Unconscious Neuro-reinforcement in people with Phobia, run by University of California, Los Angeles at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Phobia
- What is being tested?
- Unconscious Neuro-reinforcement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2024to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kainoa R MacDonald, B.A. contact
United States1 site, 1 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Michelle G Craske, PhD, 310-206-9191, MCraske@mednet.ucla.edu
Michelle G. Craske, Ph.D
About this study
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.
Read the 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
- Phobia
- Being tested
- Unconscious Neuro-reinforcement
- Keywords
- unconscious fear extinction, anxiety disorders, decoded neuro-reinforcement
- Medical subject headings
- Phobic Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unconscious Neuro-reinforcementBehavioural
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.
Unconscious Neuro-reinforcementBehavioural
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 3 sessions of neuro-reinforcement.
Unconscious Neuro-reinforcementBehavioural
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 5 sessions of neuro-reinforcement.
| Study group | Role | What they receive |
|---|---|---|
| 1 Session | Experimental | 1 neuro-reinforcement session Receives: Behavioral: Unconscious Neuro-reinforcement |
| 3 Sessions | Experimental | 3 neuro-reinforcement sessions Receives: Behavioral: Unconscious Neuro-reinforcement |
| 5 sessions | Experimental | 5 neuro-reinforcement sessions Receives: Behavioral: Unconscious Neuro-reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 days (measured at pre-treatment and 2 weeks)
Secondary outcomes (10)
Skin Conductance Response: Physiological Arousal Post-treatment Minus Pre-treatment
Skin conductance to image presentation of targeted phobic stimuli post-treatment minus pre-treatment
Measured: 14 days (measured at pre-treatment and 2 weeks)
Fear Survey Schedule
Subjective fear ratings of a list of typical phobic stimuli Minimum score of 40, maximum of 200, higher scores mean worse outcome.
Measured: 14 days (measured at pre-treatment and 2 weeks)
Stroop Task Post-treatment Minus Pre-treatment
Measure of preferential allocation of attentional resources measured in reaction time (seconds) for visual presentation of the targeted phobic stimulus
Measured: 14 days (measured at pre-treatment and 2 weeks)
Approach/Avoidance Behavior in VR Post-treatment Minus Pre-treatment
Maximal approach distance will be assessed in a behavioral approach test conducted in a virtual reality context. The Behavioral Approach Test follows a ten-step procedure of increasing difficulty to approach a feared animal (e.g. snakes), beginning with a first step such as standing in the same room as the feared animal. Then, participants approach the feared animal step-by-step, taking time at each step, until a final step such as holding the feared animal or having it touch you is reached. Behavioral outcomes that will be measured from the Behavioral Approach Test include a) maximal approach distance and b) subjective fear ratings at each distance. Minimum score for approach distance is 1, and highest is 10 (numbers represent steps taken toward fearful stimulus). Higher scores represent a better outcome on this task.
Measured: 14 days (measured at pre-treatment and 2 weeks)
Subjective Fear Ratings in Virtual Reality (VR) Post-treatment Minus Pre-treatment
Subjective fear ratings will be assessed at each distance in a behavioral approach test conducted in a virtual reality context. The Behavioral Approach Test follows a ten-step procedure of increasing difficulty to approach a feared animal (e.g. snakes), beginning with a first step such as standing in the same room as the feared animal. Then, participants approach the feared animal step-by-step, taking time at each step, until a final step such as holding the feared animal or having it touch you is reached. Minimum score for subjective fear is 1, and maximum is 8. Higher scores represent a worse outcome on this task.
Measured: 14 days (measured at pre-treatment and 2 weeks)
Patient Health Questionnaire (PHQ-9)
Self-reported depression severity. Scores range from 0-27, with higher scores indicating greater severity.
Measured: 14 days (measured at pre-treatment and 2 weeks)
Generalized Anxiety Disorder-7 (GAD-7)
Self-reported anxiety severity. Scores range from 0-21, with higher scores indicating greater severity.
Measured: 14 days (measured at pre-treatment and 2 weeks)
Severity of Phobias questionnaire
Self-report severity of phobias rating; 10 items. Scores range from "Never" to "All of the time," with a higher score indicating greater severity.
Measured: 14 days/6 weeks (measured at pre-treatment, 2 weeks, and 6 weeks)
Behavioral Inhibition/Behavioral Activation Scales (BIS/BAS)
Self-report behavioral inhibition/activation rating; 20 items. Scores range from "Very true for me" to "Very false for me," with a higher score indicating greater severity.
Measured: 0 days (measured at pre-treatment)
Vividness of Visual Imagery Questionnaire (VVIQ)
Self-report vividness of visual imagery; 16 items. Scores range from "No image at all, you only "know" that you are thinking of the object" to "Perfectly real and vivid as real seeing," where higher scores indicate greater vividness of imagery.
Measured: 0 days (measured at pre-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start9 Sep 2024
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhobiaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Michelle Craske, University of California, Los Angeles
- Investigators
- Michelle G Craske, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420557
- Sponsor's protocol ID
- 23-001604
- Other IDs
- R33MH135002
- Acronym
- DecNef
- Status last verified
- Sep 2026
- First submitted
- 14 May 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unconscious Reduction of Fear Through Decoded Neuro-Reinforcement
- ClinicalTrials.gov ID
- NCT06420557
- Acronym / sponsor ID
- DecNef / 23-001604
- Conditions
- Phobia
- Keywords
- unconscious fear extinction, anxiety disorders, decoded neuro-reinforcement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Session | Experimental | Behavioral: Unconscious Neuro-reinforcement1 neuro-reinforcement session |
| 3 Sessions | Experimental | Behavioral: Unconscious Neuro-reinforcement3 neuro-reinforcement sessions |
| 5 sessions | Experimental | Behavioral: Unconscious Neuro-reinforcement5 neuro-reinforcement sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unconscious 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. | Behavioural | 1 Session |
| Unconscious 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. | Behavioural | 3 Sessions |
| Unconscious 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. | Behavioural | 5 sessions |
Primary outcome
Change in Amygdala Reactivity
Time frame: 14 days (measured at pre-treatment and 2 weeks)
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.
Subjective Fear Post-treatment Minus Pre-treatment
Time frame: 14 days (measured at pre-treatment and 2 weeks)
Subjective Fear Ratings of images of targeted phobic stimuli Minimum score of 0, Maximum score of 180, higher scores mean worse outcome.
10 secondary outcomes
Skin Conductance Response: Physiological Arousal Post-treatment Minus Pre-treatment
Time frame: 14 days (measured at pre-treatment and 2 weeks)
Fear Survey Schedule
Time frame: 14 days (measured at pre-treatment and 2 weeks)
Stroop Task Post-treatment Minus Pre-treatment
Time frame: 14 days (measured at pre-treatment and 2 weeks)
Approach/Avoidance Behavior in VR Post-treatment Minus Pre-treatment
Time frame: 14 days (measured at pre-treatment and 2 weeks)
Subjective Fear Ratings in Virtual Reality (VR) Post-treatment Minus Pre-treatment
Time frame: 14 days (measured at pre-treatment and 2 weeks)
Patient Health Questionnaire (PHQ-9)
Time frame: 14 days (measured at pre-treatment and 2 weeks)
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 14 days (measured at pre-treatment and 2 weeks)
Severity of Phobias questionnaire
Time frame: 14 days/6 weeks (measured at pre-treatment, 2 weeks, and 6 weeks)
Behavioral Inhibition/Behavioral Activation Scales (BIS/BAS)
Time frame: 0 days (measured at pre-treatment)
Vividness of Visual Imagery Questionnaire (VVIQ)
Time frame: 0 days (measured at pre-treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kainoa R MacDonald, B.A. contact
Michelle G Craske, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unconscious Neuro-reinforcement in people with Phobia, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriel J Fiol, B.A. (7252228834, gfiol@psych.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Amygdala Reactivity (time frame: 14 days (measured at pre-treatment and 2 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.