Treating Phobia With Multivoxel Neuro-reinforcement

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03655262

Enrollment

Registered

2018-08-31

Start date

2018-10-01

Completion date

2022-06-30

Last updated

2024-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phobia

Keywords

unconscious fear extinction, anxiety disorders, decoded neuro-reinforcement

Brief summary

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

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.

Interventions

BEHAVIORALUnconscious 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Amygdala Reactivity	10 days (measured at pre-treatment and post-treatment)	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	10 days (measured at pre-treatment and post-treatment)	Subjective Fear Ratings of images of targeted phobic stimuli Minimum score of 0, Maximum score of 180, higher scores mean worse outcome.

Secondary

Measure	Time frame	Description
Skin Conductance Response: Physiological Arousal Post-treatment Minus Pre-treatment	10 days (measured at pre-treatment and post-treatment)	Skin conductance to image presentation of targeted phobic stimuli post-treatment minus pre-treatment
Fear Survey Schedule	10 days (measured at pre-treatment and post-treatment)	Subjective fear ratings of a list of typical phobic stimuli Minimum score of 40, maximum of 200, higher scores mean worse outcome.
Stroop Task Post-treatment Minus Pre-treatment	10 days (measured at pre-treatment and post-treatment)	Measure of preferential allocation of attentional resources measured in reaction time (seconds) for visual presentation of the targeted phobic stimulus

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	7
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.	8
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.	8
Total	23

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Withdrawal by Subject	0	0	1

Baseline characteristics

Characteristic	1 Session	3 Sessions	5 Sessions	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	7 Participants	8 Participants	8 Participants	23 Participants
Age, Continuous	26 Years STANDARD_DEVIATION 6.78	24.14 Years STANDARD_DEVIATION 14.24	25.86 Years STANDARD_DEVIATION 8.11	25.3 Years STANDARD_DEVIATION 9.88
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	1 Participants	4 Participants	6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants	7 Participants	4 Participants	17 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	3 Participants	5 Participants	2 Participants	10 Participants
Race (NIH/OMB) Black or African American	0 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	0 Participants	2 Participants	4 Participants
Race (NIH/OMB) White	2 Participants	2 Participants	4 Participants	8 Participants
Sex: Female, Male Female	6 Participants	8 Participants	4 Participants	18 Participants
Sex: Female, Male Male	1 Participants	0 Participants	4 Participants	5 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 7	0 / 8	0 / 8
other Total, other adverse events	0 / 7	0 / 8	0 / 8
serious Total, serious adverse events	0 / 7	0 / 8	0 / 8

Outcome results

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.