An interventional study of Unconscious Neuro-reinforcement in Phobia, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-02.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
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.
84 studies on the registry are indexed under Phobic Disorders; 15 are open to participants now.
This study's enrollment of 23 is below the median of 66 across 69 interventional studies indexed under Phobic Disorders.
Browse Phobic Disorders studies →University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1 neuro-reinforcement session
Behavioral: Unconscious Neuro-reinforcement
3 neuro-reinforcement sessions
Behavioral: Unconscious Neuro-reinforcement
5 neuro-reinforcement sessions
Behavioral: 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.
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: 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.
Time frame: 10 days (measured at pre-treatment and post-treatment)
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: 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.
Time frame: 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
Time frame: 10 days (measured at pre-treatment and post-treatment)
| Milestone | 1 Session | 3 Sessions | 5 Sessions |
|---|---|---|---|
| Started | 7 | 8 | 8 |
| Completed | 7 | 8 | 7 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
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.
| Beta Coefficient | 1 Session | 3 Sessions | 5 Sessions |
|---|---|---|---|
| Change in Amygdala Reactivity | -.691 ± .796 | -.827 ± 1.620 | -.278 ± 1.682 |
Subjective Fear Ratings of images of targeted phobic stimuli Minimum score of 0, Maximum score of 180, higher scores mean worse outcome.
| units on a scale | 1 Session | 3 Sessions | 5 Sessions |
|---|---|---|---|
| Subjective Fear Post-treatment Minus Pre-treatment | 0.32 ± 0.32 | -0.03 ± 0.37 | 0.43 ± 0.97 |
Skin conductance to image presentation of targeted phobic stimuli post-treatment minus pre-treatment
| Square Rooted Microsiemens | 1 Session | 3 Sessions | 5 Sessions |
|---|---|---|---|
| Skin Conductance Response: Physiological Arousal Post-treatment Minus Pre-treatment | -0.010 ± 0 | -0.097 ± 0.181 | -0.030 ± 0.192 |
Subjective fear ratings of a list of typical phobic stimuli Minimum score of 40, maximum of 200, higher scores mean worse outcome.
| units on a scale | 1 Session | 3 Sessions | 5 Sessions |
|---|---|---|---|
| Fear Survey Schedule | -2.46 ± 1.13 | -5.00 ± 1.12 | -11.93 ± 1.02 |
Measure of preferential allocation of attentional resources measured in reaction time (seconds) for visual presentation of the targeted phobic stimulus
| Seconds | 1 Session | 3 Sessions | 5 Sessions |
|---|---|---|---|
| Stroop Task Post-treatment Minus Pre-treatment | -0.080 ± .079 | -0.137 ± .198 | -0.030 ± .203 |
Collected over 2 years, 5 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1 Session | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| 3 Sessions | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| 5 Sessions | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Categorical(Participants) | 1 Session | 3 Sessions | 5 Sessions | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 8 | 8 | 23 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(Years) | 1 Session | 3 Sessions | 5 Sessions | Total |
|---|---|---|---|---|
| Mean | 26 ± 6.78 | 24.14 ± 14.24 | 25.86 ± 8.11 | 25.3 ± 9.88 |
| Sex: Female, Male(Participants) | 1 Session | 3 Sessions | 5 Sessions | Total |
|---|---|---|---|---|
| Female | 6 | 8 | 4 | 18 |
| Male | 1 | 0 | 4 | 5 |
| Ethnicity (NIH/OMB)(Participants) | 1 Session | 3 Sessions | 5 Sessions | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 4 | 6 |
| Not Hispanic or Latino | 6 | 7 | 4 | 17 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 1 Session | 3 Sessions | 5 Sessions | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 3 | 5 | 2 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 1 |
| White | 2 | 2 | 4 | 8 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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