Clinical trial NCT06132659: Neurofeedback Enhanced Cognitive Reappraisal Training
Official title: Neurofeedback Enhanced Cognitive Reappraisal Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Social Anxiety Disorder
Panic Disorder
Generalized Anxiety Disorder
Keywords: functional magnetic resonance imaging
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Brain & Behavior Research Foundation
First posted: 2023-11-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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

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".

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 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

Primary outcomes:
measure: Change in prefrontal cortex (PFC) activity (baseline to transfer run) from the reappraise > look contrast on the Emotion Regulation Task (ERT)
timeFrame: Approximately 60 minutes
measure: Change in negative affect ratings of images from International Affective Picture System (IAPS)
timeFrame: Approximately 60 minutes
Secondary outcomes:
measure: Change in amygdala-PFC functional connectivity (baseline to transfer) from reappraise > look contrast
timeFrame: Approximately 60 minutes
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Stefanie Russman Block, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: