COMPLETED

Neurofeedback to Treat Depression

Conditions

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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

This study tests the efficacy of a new psychotherapeutic strategy for reducing negative attention bias (and therefore depression severity) in participants with MDD (60 in R61 phase and 80 in R33 Phase). This real-time fMRI neurofeedback therapy uses cloud-based pattern classification to decode a patient's attentional state and dynamically modulate task stimuli (in a closed loop) based on this state.

Official Title

Reducing Neural Perseveration Through Closed Loop Real Time fMRI Neurofeedback to Alleviate Depressive Symptoms

Quick Facts

Study Start:2022-05-25

Study Completion:2025-06-13

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05169346

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 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* gender, inclusive * adult aged 18 - 65 meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for MDD according to the Clinician-Administered MDD Scale for DSM-5 (unipolar depression or bipolar II depressed) * scores at least a minimum score of 16 on Montgomery Asberg Depression Rating Scale (MADRS) * normal cognition * participants must be able to read and understand English * participants must be able to provide consent	* pregnancy (female participants) * outside age range * MRI contraindications (medical implant, claustrophobia, etc.) * use of psychoactive medication (including antidepressants) or currently in therapy * neurological disorder or any condition that in the view of the PI could impact brain data, cause depression, require medication that could cause depressive symptoms, or otherwise result in participant being unfit for study (for example, co-morbid psychotic, neurological disorders, developmentally or cognitively disabled/impaired, active alcohol or drug abuse/dependence within the past 6 months). * non-English speaking * non-correctable vision loss * refusal to provide informed consent * representing an active suicide risk

Inclusion Criteria

Exclusion Criteria

* gender, inclusive
* adult aged 18 - 65 meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for MDD according to the Clinician-Administered MDD Scale for DSM-5 (unipolar depression or bipolar II depressed)
* scores at least a minimum score of 16 on Montgomery Asberg Depression Rating Scale (MADRS)
* normal cognition
* participants must be able to read and understand English
* participants must be able to provide consent

* pregnancy (female participants)
* outside age range
* MRI contraindications (medical implant, claustrophobia, etc.)
* use of psychoactive medication (including antidepressants) or currently in therapy
* neurological disorder or any condition that in the view of the PI could impact brain data, cause depression, require medication that could cause depressive symptoms, or otherwise result in participant being unfit for study (for example, co-morbid psychotic, neurological disorders, developmentally or cognitively disabled/impaired, active alcohol or drug abuse/dependence within the past 6 months).
* non-English speaking
* non-correctable vision loss
* refusal to provide informed consent
* representing an active suicide risk

Contacts and Locations

Principal Investigator

Yvette I Sheline, MD

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

Center for Neuromodulation in Depression and Stress

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Yvette I Sheline, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

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 Date2022-05-25

Study Completion Date2025-06-13

Study Record Updates