Neurofeedback Enhanced Cognitive Reappraisal Training

University of Michigan

Status: Enrolling

Conditions: Panic Disorder; Generalized Anxiety Disorder; Social Anxiety Disorder; Anxiety

Treatments: Other: fMRI with Sham-NF; Other: Functional magnetic resonance imaging (fMRI) with Veritable-NF

Study type: Interventional

Funder types: Other

Identifiers

NCT06132659

HUM00209563

Details and patient eligibility

About

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

Full 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".

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Veritable-NF (MPC)

Experimental group

Treatment:

Other: Functional magnetic resonance imaging (fMRI) with Veritable-NF

Sham-NF

Active Comparator group

Treatment:

Other: fMRI with Sham-NF

Veritable-NF (PFC)

Active Comparator group

Treatment:

Other: Functional magnetic resonance imaging (fMRI) with Veritable-NF