Treating Phobia With Multivoxel Neuro-reinforcement

Study Overview
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Brief Summary
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Specific phobias and other anxiety disorders represent a major mental health problem, and present a significant challenge to researchers because effective treatment usually involves repeated exposure to feared stimuli, and the high levels of associated distress can lead to termination of treatment. Recent advances in computational functional magnetic resonance imaging (fMRI) provide a method by which individuals may be unconsciously exposed to fearful stimuli, leading to effective fear reduction while eliminating a primary cause of attrition. The objective of the current study is to use the novel approach of neuro-reinforcement based on decoded fMRI information to reduce fear responses to fearful stimuli (e.g., spiders, heights) in individuals with phobias, directly and unconsciously in the brain, without repeatedly exposing participants to their feared stimuli. Participants will be randomized into one of three groups of varying neuro-reinforcement sessions (1, 3, or 5). They will complete tests of subjective fear and directed attention while being scanned by fMRI to measure engagement of amygdala activity to fearful stimuli as well as measured through other indicators of fear such as skin conductance response.

Detailed Description
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Anxiety disorders, the most common group of mental disorders in the United States, represent a major mental health problem. Phobias, in which fear and anxiety are triggered by a specific stimulus or situation, are the largest category of anxiety disorders and affect 5 - 12% of the world's population. Exposure-based therapies are effective in reducing symptoms, but their effectiveness depends on the individual's capacity or willingness to consciously confront their feared object. The associated distress can be so extreme that it prevents patients from seeking treatment, and contributes to attrition from exposure once treatment begins. As a result, there is an unmet need for treatment that minimizes attrition and subjective patient discomfort. The current study uses a novel technique of neuro-reinforcement based on decoded fMRI information to reduce fear responses to fearful stimuli directly and unconsciously without repeatedly exposing participants to those stimuli. The goals are to (1) confirm that our method decreases amygdala reactivity to images of phobic stimuli as well as (2) determine dosage-response optimization.

Official Title
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Treating Phobia With Multivoxel Neuro-reinforcement

Conditions
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Phobia

Intervention / Treatment
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* Behavioral: Unconscious Neuro-reinforcement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individual has normal or corrected to normal vision Individual has normal or corrected to normal hearing Individual is competent to understand informed consent Exclusion Criteria: 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: PTSD, Obsessive Compulsive Disorder, Substance Use Disorder, Current Major Depression, Bipolar Disorder, Psychosis, neurologic diagnoses or unstable serious medical conditions 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Session<br>1 neuro-reinforcement session | Behavioral: Unconscious Neuro-reinforcement<br>* 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 x day(s) of neuro-reinforcement.<br>|
| Experimental: 3 Sessions<br>3 neuro-reinforcement sessions | Behavioral: Unconscious Neuro-reinforcement<br>* 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 x day(s) of neuro-reinforcement.<br>|
| Experimental: 5 sessions<br>5 neuro-reinforcement sessions | Behavioral: Unconscious Neuro-reinforcement<br>* 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 x day(s) of neuro-reinforcement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 days (measured at pre-treatment and post-treatment) | 
| 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. | 10 days (measured at pre-treatment and post-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Conductance Response: Physiological Arousal Post-treatment Minus Pre-treatment | Skin conductance to image presentation of targeted phobic stimuli post-treatment minus pre-treatment | 10 days (measured at pre-treatment and post-treatment) | 
| 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. | 10 days (measured at pre-treatment and post-treatment) | 
| 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 | 10 days (measured at pre-treatment and post-treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unconscious fear extinction, anxiety disorders, decoded neuro-reinforcement