Clinical Trials Directory

Trials / Completed

CompletedNCT05169346

Neurofeedback to Treat Depression

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
71 (actual)
Sponsor
University of Pennsylvania · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

In both the R61and R33 phases we will compare cloud based real time fMRI feedback with placebo (sham feedback) in reducing negative attention bias and depressive symptoms. This study will be the first dose-finding test of real-time fMRI effect on negative attention bias. Measures include: Structured Clinical Interview for DSM-5 (SCID), Clinician-administered diagnostic exam, Montgomery Asberg Depression Rating Scale (MADRS), Clinician-administered scale used to assess the severity of depression, State-Trait Anxiety Inventory (STAI), Self-report questionnaire used to measure types of anxiety and mood symptoms, Mood and Anxiety Symptom Questionnaire (MASQ), Negative perseveration during a go/no-go task, Go/no-go task with overlaid face/scene stimuli; brain response triggers next stimulus, Negative gaze, Negative gaze collected in gaze data following each real time fMRI feedback session

Conditions

Interventions

TypeNameDescription
BEHAVIORALActive Closed Loop Real Time fMRI NeurofeedbackActive neurofeedback to target neural mechanisms underlying attentional bias in participants with major depressive discover (MDD)
BEHAVIORALSham Closed Loop Real Time fMRI NeurofeedbackSham (placebo) neurofeedback to target neural mechanisms underlying attentional bias in participants with major depressive discover (MDD)

Timeline

Start date
2022-05-25
Primary completion
2025-06-06
Completion
2025-06-13
First posted
2021-12-23
Last updated
2025-09-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05169346. Inclusion in this directory is not an endorsement.