Neurofeedback Enhanced Cognitive Reappraisal Training - Phase 4
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Functional magnetic resonance imaging (fMRI) with Veritable-NF, fMRI with Sham-NF.
- Who it may be relevant to
- Registry conditions: Anxiety, Social Anxiety Disorder, Panic Disorder, Generalized Anxiety Disorder. Basic parameters: 18 years — 24 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study seeks to understand emotion regulation in those with young adults with anxiety using real-time functional magnetic resonance imaging neurofeedback, a tool that allows individuals to control brain activity. The goal of this project is to understand how receiving feedback about one's own brain activity relates to emotion regulation ability. This work will help the study team understand the brain areas involved in emotion regulation and could lay the groundwork to test if psychotherapy outcomes can be enhanced using neurofeedback. The study hypotheses include: * Participants receiving veritable-Neurofeedback (NF) will show a greater activation increases in the prefrontal cortex (PFC) compared to sham-NF * Participants receiving veritable-NF will show greater cognitive reappraisal (CR) ability compared to those receiving sham-NF * PFC activation will positively correlate with CR ability
Interventions
- Other Functional magnetic resonance imaging (fMRI) with Veritable-NF
Participants will complete 4 visits (some can be done virtually). The baseline visit will include a clinical interview. Eligible participants will complete a series of questionnaires and a practice session at visit 2, and may do a mock scan if the visit is in person. Visit 3 will take place within 5 days of the practice session. Participants will have an fMRI with real neurofeedback and answer a series of questions pertaining to the scan. 2 weeks after visit 3, participants will revisit the ques - Other fMRI with Sham-NF
Participants will complete 4 visits (some can be done virtually). The baseline visit will include a clinical interview. Eligible participants will complete a series of questionnaires and a practice session at visit 2, and may do a mock scan if the visit is in person. Visit 3 will take place within 5 days of the practice session. Participants will have an fMRI with neurofeedback that looks similar to real neurofeedback but does not reflect their true brain signal. Afterwards, they will answer a s
Primary outcome measures
- Change in prefrontal cortex (PFC) activity (baseline to transfer run) from the reappraise > look contrast [Time frame: Approximately 60 minutes]
- Change in negative affect ratings of images from the International Affective Picture System (IAPS) [Time frame: Approximately 60 minutes]
Secondary outcome measures (1)
- Change in amygdala-PFC functional connectivity (baseline to transfer) from reappraise > look contrast [Time frame: Approximately 60 minutes]
Eligibility criteria
Inclusion criteria
- Primary diagnosis (primary source of distress and/or interference) of generalized anxiety disorder, social anxiety disorder, panic disorder or illness anxiety disorder based on structured interview. Comorbid phobic disorders allowed, but these cannot be the primary source of interference or distress due to the lowered chances of encountering anxiety-provoking stimuli during the study period
- Score of 2 or more on at least 1 question from GAD/CROSS-AD composite
- Medically and physically able to consent
- Not regularly taking any medication, prescription or non-prescription, with psychotropic effects other than:
- Buspirone, or antidepressant (e.g., selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)) with stable dosage for past 4 weeks
- The same oral hormonal contraceptive for at least 3 months
- For females, not currently pregnant or actively trying to become pregnant
- Ability to tolerate small, enclosed spaces without anxiety
- No metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition (per protocol)
- Size compatible with scanner gantry (per protocol)
Exclusion criteria
- Current diagnosis of Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, or Bipolar Disorder
- Current substance abuse or dependence (past 6 months)
- Active suicidality with plan or intent
- Current psychosis
- History of serious neurological illness or current medical condition that could compromise brain function, such as liver failure
- History of closed head injury, e.g., loss of consciousness greater (>) approximately (\~) 5 minutes, hospitalization, neurological sequela
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT06563310 · HUM00209563 - phase 4 · 1K23MH133063-01A1