Unconscious Reduction of Fear Through Decoded Neuro-Reinforcement
ConditionPhobia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of California, Los Angeles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Unconscious Neuro-reinforcement
BehavioralIndividuals 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-reinforcement
BehavioralIndividuals 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-reinforcement
BehavioralIndividuals 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: 1 SessionExperimental treatment 1 intervention
Group B: 3 SessionsExperimental treatment 1 intervention
Group C: 5 sessionsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
14 days (measured at pre-treatment and 2 weeks)2
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.
Time frame
14 days (measured at pre-treatment and 2 weeks)Secondary outcomes
1
Skin Conductance Response: Physiological Arousal Post-treatment Minus Pre-treatment
Skin conductance to image presentation of targeted phobic stimuli post-treatment minus pre-treatment
Time frame
14 days (measured at pre-treatment and 2 weeks)2
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.
Time frame
14 days (measured at pre-treatment and 2 weeks)3
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
Time frame
14 days (measured at pre-treatment and 2 weeks)4
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.
Time frame
14 days (measured at pre-treatment and 2 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov