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Treating Phobia With Multivoxel Neuro-reinforcement

Primary Purpose

Phobia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Unconscious Neuro-reinforcement

About this trial

This is an interventional treatment trial for Phobia focused on measuring unconscious fear extinction, anxiety disorders, decoded neuro-reinforcement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of California, Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

1 Session

3 Sessions

5 sessions

Arm Description

1 neuro-reinforcement session

3 neuro-reinforcement sessions

5 neuro-reinforcement sessions

Outcomes

Primary Outcome Measures

Change in Amygdala Reactivity

The neural measure of amygdala reactivity (measured by fMRI) to feared object categories.

Subjective Fear

Subjective Fear Ratings of targeted and non-targeted phobic stimuli (animal), non-phobic stimuli (animal, neutral object)

Secondary Outcome Measures

Skin Conductance Response: physiological arousal

Skin conductance to targeted and non-targeted phobic stimuli (animal), non-phobic stimuli (animal, neutral object)

Fear Survey Schedule

Subjective fear ratings of a list of typical phobic stimuli

Stroop Task

Measure of preferential allocation of attentional resources (targeted and non-targeted phobic stimuli (animal), non-phobic stimuli (animal, neutral object))

Full Information

NCT ID

NCT03655262

First Posted

August 28, 2018

Last Updated

August 25, 2022

Sponsor

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT03655262

Brief Title

Treating Phobia With Multivoxel Neuro-reinforcement

Official Title

Treating Phobia With Multivoxel Neuro-reinforcement

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

June 30, 2022 (Actual)

Study Completion Date

June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Phobia

Keywords

unconscious fear extinction, anxiety disorders, decoded neuro-reinforcement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 Session

Arm Type

Experimental

Arm Description

1 neuro-reinforcement session

Arm Title

3 Sessions

Arm Type

Experimental

Arm Description

3 neuro-reinforcement sessions

Arm Title

5 sessions

Arm Type

Experimental

Arm Description

5 neuro-reinforcement sessions

Intervention Type

Behavioral

Intervention Name(s)

Unconscious Neuro-reinforcement

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Amygdala Reactivity

Description

The neural measure of amygdala reactivity (measured by fMRI) to feared object categories.

Time Frame

10 days (measured at pre-treatment and post-treatment)

Title

Subjective Fear

Description

Subjective Fear Ratings of targeted and non-targeted phobic stimuli (animal), non-phobic stimuli (animal, neutral object)

Time Frame

10 days (measured at pre-treatment and post-treatment)

Secondary Outcome Measure Information:

Title

Skin Conductance Response: physiological arousal

Description

Skin conductance to targeted and non-targeted phobic stimuli (animal), non-phobic stimuli (animal, neutral object)

Time Frame

10 days (measured at pre-treatment and post-treatment)

Title

Fear Survey Schedule

Description

Subjective fear ratings of a list of typical phobic stimuli

Time Frame

10 days (measured at pre-treatment and post-treatment)

Title

Stroop Task

Description

Measure of preferential allocation of attentional resources (targeted and non-targeted phobic stimuli (animal), non-phobic stimuli (animal, neutral object))

Time Frame

10 days (measured at pre-treatment and post-treatment)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University of California, Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Treating Phobia With Multivoxel Neuro-reinforcement

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