RECRUITING

Amygdala Neurofeedback for Depression - Large Scale Clinical Trial

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Conditions

Major Depressive Disorderneurofeedbackamygdaladepression

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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

The goal of this study is to evaluate whether rtfMRI-nf training to increase the amygdala response to positive memories may serve as a stand-alone intervention for major depressive disorder

Official Title

Confirmatory Efficacy Randomized Clinical Trial of Amygdala Neurofeedback for Major Depressive Disorder

Quick Facts

Study Start:2023-06-01
Study Completion:2028-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05703256

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 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * ages 18 - 55
  2. * primary diagnosis of MDD and are currently depressed
  3. * able to give written informed consent prior to participation
  4. * unmedicated OR are stable on an antidepressant regime (at least 4 weeks to ensure symptoms are stable). Effective medications will not be discontinued for the purposes of the study.
  1. * clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
  2. * Current severe DSM-V alcohol or substance use disorder, with the exception of nicotine or caffeine. Clinician will access subjects' alcohol and substance use on a case-by-case to determine whether specific cases of mild or moderate alcohol or substance use would also interfere with the effects of the intervention.
  3. * history of traumatic brain injury
  4. * unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
  5. * currently pregnant or breast feeding
  6. * unable to complete questionnaires written in English
  7. * current (within 3 weeks of testing) use of any antipsychotics, anticonvulsants, stimulants, benzodiazepines, beta-blockers, or other medications (except antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study.
  8. * diagnosis of psychotic or organic mental disorder, bipolar I or II disorder.
  9. * eye problems or difficulties in corrected vision.

Contacts and Locations

Study Contact

Kymberly Young, PhD
CONTACT
412-648-6179
youngk@pitt.edu
Lisa Stupar
CONTACT
412-383-8100
stuparlm@upmc.edu

Principal Investigator

Kymberly Young, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
United States

Collaborators and Investigators

Sponsor: Kymberly Young

  • Kymberly Young, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

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 Date2023-06-01
Study Completion Date2028-04-30

Study Record Updates

Study Start Date2023-06-01
Study Completion Date2028-04-30

Terms related to this study

Keywords Provided by Researchers

  • neurofeedback
  • amygdala
  • depression
  • major depressive disorder

Additional Relevant MeSH Terms

  • Major Depressive Disorder