Anxiety & Depression Association of America

Neurofeedback Enhanced Cognitive Reappraisal Training - Phase 4

Purpose

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 ventrolateral prefrontal cortex (vlPFC) compared to sham-NF - Participants receiving veritable-NF will show greater cognitive reappraisal (CR) ability compared to those receiving sham-NF - vlPFC activation will positively correlate with CR ability

Conditions

Anxiety
Social Anxiety Disorder
Panic Disorder
Generalized Anxiety Disorder

Eligibility

Eligible Ages: Between 18 Years and 24 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 - 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: 1. Buspirone, or antidepressant (e.g., selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)) with stable dosage for past 4 weeks 2. 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 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

Arm	Description	Assigned Intervention
Experimental Veritable-NF		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 questionnaires they completed at baseline. Visit 4 will take place one month after visit 3 and will include a follow-up interview with an assessor and the final questionnaire collection.
Active Comparator Sham-NF		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 series of questions pertaining to the scan. 2 weeks after visit 3, participants will revisit the questionnaires they completed at baseline. Visit 4 will take place one month after visit 3 and will include a follow-up interview with an assessor and the final questionnaire collection.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: University of Michigan

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.