Neurofeedback to Treat Depression

Not Applicable

Recruiting

• Conditions: MDD
• Interventions: Behavioral: Active Closed Loop Real Time fMRI Neurofeedback; Behavioral: Sham Closed Loop Real Time fMRI Neurofeedback

• Registration Number: NCT05169346
• Lead Sponsor: University of Pennsylvania

Brief 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-21
• Study First Posted: 2021-12-23
• Study Start: 2022-05-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Neurofeedback	Active Closed Loop Real Time fMRI Neurofeedback	R61 Phase: Four training sessions. Each training session contains 32 minutes of active neurofeedback runs. R33 Phase: Number of training sessions are contingent on R61 findings.
Sham Neurofeedback	Sham Closed Loop Real Time fMRI Neurofeedback	R61 Phase: Four training sessions. Each training session contains 32 minutes of sham (placebo) neurofeedback runs. R33 Phase: Number of training sessions are contingent on R61 findings.

Primary Outcome Measures

Name	Time	Method
Attention Mechanism of Depression	5 years	Associate neurofeedback related changes in our hypothesized attentional mechanism of depression (i.e. neural perseveration of negative states) with changes in depression severity as measured by the Montgomery Asberg Depression Rating Scale (MADRS).

Trial Locations

Locations (1)

Center for Neuromodulation in Depression and Stress; 🇺🇸 Philadelphia, Pennsylvania, United States