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Search / Trial NCT06132659

Neurofeedback Enhanced Cognitive Reappraisal Training

Launched by UNIVERSITY OF MICHIGAN · Nov 9, 2023

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

Functional Magnetic Resonance Imaging

ClinConnect Summary

This clinical trial is studying a new way to help people with anxiety disorders, such as social anxiety, panic disorder, and generalized anxiety disorder. The researchers want to see if using a special tool called neurofeedback, which allows individuals to see and control their brain activity in real-time, can improve their ability to manage emotions. By understanding how brain activity relates to emotion regulation, the study hopes to find better ways to enhance therapy outcomes for those struggling with anxiety.

To participate in this trial, you should be between the ages of 65 to 88 and have a primary diagnosis of one of the anxiety disorders mentioned. You should not be taking any medications that affect your mood (except for certain antidepressants) and must be able to comfortably tolerate being in small, enclosed spaces, as the study involves a type of brain scan. Participants will receive either real neurofeedback or a placebo (inactive version) while learning skills to manage emotions. This research could lead to new treatments that help people better cope with their anxiety.

Gender

ALL

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

About University Of Michigan

The University of Michigan, a leading academic institution renowned for its commitment to advancing healthcare and medical research, serves as a prominent clinical trial sponsor. With a robust infrastructure that supports innovative research initiatives, the university leverages its multidisciplinary expertise to conduct a wide array of clinical trials aimed at improving patient outcomes and advancing medical knowledge. Through its state-of-the-art facilities and collaborative environment, the University of Michigan fosters partnerships between researchers, clinicians, and industry leaders, ensuring the development of cutting-edge therapies and interventions that address pressing health challenges.

Locations

Ann Arbor, Michigan, United States

Ann Arbor, Michigan, United States

Patients applied

0 patients applied

Trial Officials

Stefanie Russman Block, Ph.D

Principal Investigator

University of Michigan

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported