PhobiaNCT03655262
Treating Phobia With Multivoxel Neuro-reinforcement
A study testing Unconscious Neuro-reinforcement in people with Phobia, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Phobia
- What is being tested?
- Unconscious Neuro-reinforcement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individual has normal or corrected to normal vision
- Individual has normal or corrected to normal hearing
- Individual is competent to understand informed consent
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
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.
Read the 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.
- Conditions
- Phobia
- Being tested
- Unconscious Neuro-reinforcement
- Keywords
- unconscious fear extinction, anxiety disorders, decoded neuro-reinforcement
- Medical subject headings
- Phobic Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unconscious Neuro-reinforcementBehavioural
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 group | Role | What they receive |
|---|---|---|
| 1 Session | Experimental | 1 neuro-reinforcement session Receives: Behavioral: Unconscious Neuro-reinforcement |
| 3 Sessions | Experimental | 3 neuro-reinforcement sessions Receives: Behavioral: Unconscious Neuro-reinforcement |
| 5 sessions | Experimental | 5 neuro-reinforcement sessions Receives: Behavioral: Unconscious Neuro-reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 days (measured at pre-treatment and post-treatment)
Secondary outcomes (3)
Skin Conductance Response: Physiological Arousal Post-treatment Minus Pre-treatment
Skin conductance to image presentation of targeted phobic stimuli post-treatment minus pre-treatment
Measured: 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.
Measured: 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
Measured: 10 days (measured at pre-treatment and post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Oct 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PhobiaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Craske, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655262
- Sponsor's protocol ID
- R61MH113772
- Status last verified
- Jan 2024
- First submitted
- 28 Aug 2018
- Last updated
- 2 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39221769Cushing 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.
PubMed 39132473
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Phobia With Multivoxel Neuro-reinforcement
- ClinicalTrials.gov ID
- NCT03655262
- Acronym / sponsor ID
- R61MH113772
- Conditions
- Phobia
- Keywords
- unconscious fear extinction, anxiety disorders, decoded neuro-reinforcement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Posted 27 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Session | Experimental | Behavioral: Unconscious Neuro-reinforcement1 neuro-reinforcement session |
| 3 Sessions | Experimental | Behavioral: Unconscious Neuro-reinforcement3 neuro-reinforcement sessions |
| 5 sessions | Experimental | Behavioral: Unconscious Neuro-reinforcement5 neuro-reinforcement sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individual has normal or corrected to normal vision
- Individual has normal or corrected to normal hearing
- Individual is competent to understand informed consent
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unconscious Neuro-reinforcementIndividuals 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. | Behavioural | 1 Session, 3 Sessions, 5 sessions |
Primary outcome
Change in Amygdala Reactivity
Time frame: 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
Time frame: 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.
3 secondary outcomes
Skin Conductance Response: Physiological Arousal Post-treatment Minus Pre-treatment
Time frame: 10 days (measured at pre-treatment and post-treatment)
Fear Survey Schedule
Time frame: 10 days (measured at pre-treatment and post-treatment)
Stroop Task Post-treatment Minus Pre-treatment
Time frame: 10 days (measured at pre-treatment and post-treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39221769Cushing 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.
- Derived from this study: PubMed 39132473Cushing 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unconscious Neuro-reinforcement in people with Phobia, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Amygdala Reactivity (time frame: 10 days (measured at pre-treatment and post-treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03655262, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.