RECRUITING

Neurofeedback Enhanced Cognitive Reappraisal Training - Phase 4

Talk to us

Conditions

AnxietySocial Anxiety DisorderPanic DisorderGeneralized Anxiety Disorderfunctional magnetic resonance imaging

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 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 increases 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 * PFC activation will positively correlate with CR ability

Official Title

Neurofeedback Enhanced Cognitive Reappraisal Training - Phase 4

Quick Facts

Study Start:2025-01-09
Study Completion:2029-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06563310

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 24 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Score of 2 or more on at least 1 question from GAD/CROSS-AD composite
  3. * Medically and physically able to consent
  4. * Not regularly taking any medication, prescription or non-prescription, with psychotropic effects other than:
  5. 1. Buspirone, or antidepressant (e.g., selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)) with stable dosage for past 4 weeks
  6. 2. The same oral hormonal contraceptive for at least 3 months
  7. * For females, not currently pregnant or actively trying to become pregnant
  8. * Ability to tolerate small, enclosed spaces without anxiety
  9. * 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)
  10. * Size compatible with scanner gantry (per protocol)
  1. * Current diagnosis of Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, or Bipolar Disorder
  2. * Current substance abuse or dependence (past 6 months)
  3. * Active suicidality with plan or intent
  4. * Current psychosis
  5. * History of serious neurological illness or current medical condition that could compromise brain function, such as liver failure
  6. * History of closed head injury, e.g., loss of consciousness greater (\>) approximately (\~) 5 minutes, hospitalization, neurological sequela

Contacts and Locations

Study Contact

Sophia Hovakimian
CONTACT
734-232-0129
shovakim@med.umich.edu
Laura Stchur, MSW
CONTACT
734-936-1323
lmarine@med.umich.edu

Principal Investigator

Stefanie Russman Block, Ph.D
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Stefanie Russman Block, Ph.D, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-09
Study Completion Date2029-05

Study Record Updates

Study Start Date2025-01-09
Study Completion Date2029-05

Terms related to this study

Keywords Provided by Researchers

  • functional magnetic resonance imaging

Additional Relevant MeSH Terms

  • Anxiety
  • Social Anxiety Disorder
  • Panic Disorder
  • Generalized Anxiety Disorder