Neurofeedback-enhanced cognitive reappraisal training for young adults with anxiety
Neurofeedback Enhanced Cognitive Reappraisal Training - Phase 4
NA · University of Michigan · NCT06563310
This trial uses real-time fMRI neurofeedback to see if training the brain can help young adults with anxiety improve their emotion regulation and reappraisal skills.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 24 Years |
| Sex | All |
| Sponsor | University of Michigan (other) |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06563310 on ClinicalTrials.gov |
What this trial studies
The study enrolls young adults with a primary diagnosis of generalized anxiety disorder, social anxiety disorder, panic disorder, or illness anxiety disorder and uses real-time functional MRI neurofeedback during cognitive reappraisal tasks. Participants receive either veritable (real) neurofeedback or sham neurofeedback while fMRI records prefrontal cortex activity. The team compares changes in PFC activation and cognitive reappraisal performance between the two groups and examines correlations between brain activation and reappraisal ability. Results will help determine whether neurofeedback can augment emotion regulation training and inform future psychotherapy-enhancement efforts.
Who should consider this trial
Good fit: Ideal candidates are young adults whose primary diagnosis is generalized anxiety disorder, social anxiety disorder, panic disorder, or illness anxiety disorder who can safely undergo fMRI, are not pregnant, and are not taking unstable psychotropic medications (stable SSRIs/SNRIs or buspirone allowed).
Not a fit: People who are pregnant or trying to become pregnant, who cannot tolerate small enclosed spaces (e.g., severe claustrophobia), who have a different primary phobic disorder, or who are on unstable or prohibited psychotropic medications are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this approach could strengthen prefrontal control over emotions and improve psychotherapy outcomes for people with anxiety.
How similar studies have performed: Previous small studies of real-time fMRI neurofeedback for emotion regulation have shown promising but mixed preliminary results, so the method remains experimental.
Eligibility criteria
Show full inclusion / exclusion 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 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 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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
Study contacts
- Principal investigator: Stefanie Russman Block, Ph.D — University of Michigan
- Study coordinator: Sophia Hovakimian
- Email: shovakim@med.umich.edu
- Phone: 734-232-0129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anxiety, Social Anxiety Disorder, Panic Disorder, Generalized Anxiety Disorder, functional magnetic resonance imaging