Treating Phobia With Multivoxel Neuro-reinforcement

NCT03655262 | Completed Results

• 1 other identifier: R61MH113772
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Phobia

Keywords

unconscious fear extinction; anxiety disorders; decoded neuro-reinforcement

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (3)

• Skin Conductance Response: Physiological Arousal Post-treatment Minus Pre-treatment

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

• Fear Survey Schedule

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

• Stroop Task Post-treatment Minus Pre-treatment

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

Study Arms (3)

1 Session

EXPERIMENTAL

1 neuro-reinforcement session

Behavioral: Unconscious Neuro-reinforcement

3 Sessions

EXPERIMENTAL

3 neuro-reinforcement sessions

Behavioral: Unconscious Neuro-reinforcement

5 sessions

EXPERIMENTAL

5 neuro-reinforcement sessions

Behavioral: Unconscious Neuro-reinforcement

Interventions

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.

1 Session; 3 Sessions; 5 sessions

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual has normal or corrected to normal vision
• Individual has normal or corrected to normal hearing
• Individual is competent to understand informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• 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.

  PMID: 39221769 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.

  PMID: 39132473 DERIVED

MeSH Terms

Conditions

Phobic Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Michelle Craske, Ph. D
• Organization: UCLA

mcraske@mednet.ucla.edu

(310) 825 8403

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 31, 2018
• Study Start: October 1, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 2, 2024
• Results First Posted: December 27, 2023

Record last verified: 2024-01

Locations

US (1)