Anxiety & Depression Association of America

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 Sex: 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 the 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. Hormonal contraceptives of any type for any duration - 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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Basic Science
Masking: None (Open Label)
Masking Description: (Veritable-NF (MPC) and Sham-NF only): All staff present during the MRI session, as well as the participant, will be blinded to group assignment. A designated member of the study team will remain unblinded during the duration of the study.

Arm Groups

Arm	Description	Assigned Intervention
Experimental Veritable-NF (MPC)		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.
Active Comparator Veritable-NF (PFC)		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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: University of Michigan

Study Contact

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

Detailed Description

Due to an unforeseen error in our online neurofeedback script, in which the location of the brain region being targeted was not properly read by the script, participants in the veritable-NF group received feedback to the medial parietal cortex (MPC) instead of the PFC. A third, unrandomized arm has been added to this registration to enroll an additional subset of participants who are indeed receiving feedback to the PFC. The pre-existing veritable-NF arm has been relabeled to reflect which region of the brain was actually targeted. Additionally, the masking description has been reset to "None".

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.