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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Active Closed Loop Real Time fMRI Neurofeedback | Active neurofeedback to target neural mechanisms underlying attentional bias in participants with major depressive discover (MDD) |
| BEHAVIORAL | Sham Closed Loop Real Time fMRI Neurofeedback | Sham (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.