Status:
RECRUITING
Neurofeedback Enhanced Cognitive Reappraisal Training - Phase 4
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Anxiety
Social Anxiety Disorder
Eligibility:
All Genders
18-24 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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:
- Buspirone, or antidepressant (e.g., selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)) with stable dosage for past 4 weeks
- 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
- 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
Key Trial Info
Start Date :
January 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06563310
Start Date
January 9 2025
End Date
May 1 2029
Last Update
June 6 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109