Clinical trial NCT03655262: Treating Phobia With Multivoxel Neuro-reinforcement
Official title: Treating Phobia With Multivoxel Neuro-reinforcement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phobia
Keywords: unconscious fear extinction
anxiety disorders
decoded neuro-reinforcement
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Amygdala Reactivity
timeFrame: 10 days (measured at pre-treatment and post-treatment)
measure: Subjective Fear Post-treatment Minus Pre-treatment
timeFrame: 10 days (measured at pre-treatment and post-treatment)
Secondary outcomes:
measure: Skin Conductance Response: Physiological Arousal Post-treatment Minus Pre-treatment
timeFrame: 10 days (measured at pre-treatment and post-treatment)
measure: Fear Survey Schedule
timeFrame: 10 days (measured at pre-treatment and post-treatment)
measure: Stroop Task Post-treatment Minus Pre-treatment
timeFrame: 10 days (measured at pre-treatment and post-treatment)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
References: