Neurofeedback Enhanced Cognitive Reappraisal Training

Purpose

This study seeks to understand emotion regulation in those 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 increase 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 - Prefrontal cortex activation will positively correlate with CR ability

Conditions

  • Anxiety
  • Social Anxiety Disorder
  • Panic Disorder
  • Generalized Anxiety Disorder

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 - Medically and physically able to consent - Not taking any medication, prescription or non-prescription with psychotropic effects other than birth control or antidepressant (i.e., selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) with stable dosage for past 4 week - 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 or Posttraumatic Stress Disorder - Current course of individual or group psychotherapy - 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Double (Participant, Care Provider)
Masking Description
All staff present during the MRI session, as well as the participant, will be blinded to group assignment. The Study Coordinator will remain unblinded during the duration of the study.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Veritable-NF
  • Other: Functional magnetic resonance imaging (fMRI) with Veritable-NF
    Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with the real neurofeedback. Visit 4 will take place one month after visit 3 and will include a follow-up interview with a trainer assessor as well as questionnaires. Additionally, 2 weeks after visit 3 participants will also complete some questionnaires online.
Active Comparator
Sham-NF
  • Other: fMRI with Sham-NF
    Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with feedback that looks similar to real neurofeedback, but is computer generated. Visit 4 will take place 2 weeks after visit 3 and participants will complete more questionnaires.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
University of Michigan

Study Contact

Sophia Hovakimian
734-232-0129
shovakim@med.umich.edu