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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Session | Experimental | 1 neuro-reinforcement session |
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| 3 Sessions | Experimental | 3 neuro-reinforcement sessions |
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| 5 sessions | Experimental | 5 neuro-reinforcement sessions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 x day(s) of neuro-reinforcement. |
| 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. Lower numbers (i.e. more negative numbers) indicate greater amygdala decrease and and better outcomes. | 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39221769 | Derived | Cushing CA, Lau H, Kawato M, Craske MG, Taschereau-Dumouchel V. A double-blind trial of decoded neurofeedback intervention for specific phobias. Psychiatry Clin Neurosci. 2024 Nov;78(11):678-686. doi: 10.1111/pcn.13726. Epub 2024 Sep 2. | |
| 39132473 | Derived | Cushing CA, Lau H, Kawato M, Craske MG, Taschereau-Dumouchel V. A double-blind trial of decoded neurofeedback intervention for specific phobias. medRxiv [Preprint]. 2024 Aug 1:2023.04.25.23289107. doi: 10.1101/2023.04.25.23289107. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Session | 1 neuro-reinforcement session Unconscious Neuro-reinforcement: 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. |
| FG001 | 3 Sessions | 3 neuro-reinforcement sessions Unconscious Neuro-reinforcement: 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. |
| FG002 | 5 Sessions | 5 neuro-reinforcement sessions Unconscious Neuro-reinforcement: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Session | 1 neuro-reinforcement session Unconscious Neuro-reinforcement: 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 day(s) of neuro-reinforcement. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Beta Coefficient | 10 days (measured at pre-treatment and post-treatment) |
|
2 years, 5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Session | 1 neuro-reinforcement session Unconscious Neuro-reinforcement: 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 day(s) of neuro-reinforcement. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Craske, Ph. D | UCLA | (310) 825 8403 | mcraske@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 23, 2022 | Apr 4, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 5, 2022 | Oct 27, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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|
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) |
| BG001 | 3 Sessions | 3 neuro-reinforcement sessions Unconscious Neuro-reinforcement: 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 day(s) of neuro-reinforcement. |
| BG002 | 5 Sessions | 5 neuro-reinforcement sessions Unconscious Neuro-reinforcement: 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 day(s) of neuro-reinforcement. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 3 Sessions | 3 neuro-reinforcement sessions Unconscious Neuro-reinforcement: 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 day(s) of neuro-reinforcement. |
| OG002 | 5 Sessions | 5 neuro-reinforcement sessions Unconscious Neuro-reinforcement: 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 day(s) of neuro-reinforcement. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 10 days (measured at pre-treatment and post-treatment) |
|
|
|
| Secondary | Skin Conductance Response: Physiological Arousal Post-treatment Minus Pre-treatment | Skin conductance to image presentation of targeted phobic stimuli post-treatment minus pre-treatment | Posted | Mean | Standard Deviation | Square Rooted Microsiemens | 10 days (measured at pre-treatment and post-treatment) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 10 days (measured at pre-treatment and post-treatment) |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | Seconds | 10 days (measured at pre-treatment and post-treatment) |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 3 Sessions | 3 neuro-reinforcement sessions Unconscious Neuro-reinforcement: 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 day(s) of neuro-reinforcement. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | 5 Sessions | 5 neuro-reinforcement sessions Unconscious Neuro-reinforcement: 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 day(s) of neuro-reinforcement. | 0 | 8 | 0 | 8 | 0 | 8 |
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