Using neurofeedback to reduce depression symptoms
Reducing Neural Perseveration Through Closed Loop Real Time fMRI Neurofeedback to Alleviate Depressive Symptoms
This study is testing whether a new type of brain training using real-time feedback can help people with Major Depressive Disorder feel less depressed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05169346 on ClinicalTrials.gov |
What this trial studies
This study evaluates a novel psychotherapeutic approach that employs real-time fMRI neurofeedback to address negative attention bias in individuals with Major Depressive Disorder (MDD). Participants will receive either active neurofeedback or sham feedback, with the aim of determining the efficacy of this intervention in reducing depressive symptoms. The study will involve two phases, R61 and R33, with a total of 140 participants, and will utilize various clinical assessments to measure outcomes. This approach represents a closed-loop system that dynamically adjusts stimuli based on the participant's attentional state.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who meet the DSM-5 criteria for MDD and have a minimum score of 16 on the Montgomery Asberg Depression Rating Scale.
Not a fit: Patients who are pregnant, have MRI contraindications, or are currently on psychoactive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a new, effective treatment option for patients suffering from depression.
How similar studies have performed: While this approach is innovative, similar studies using neurofeedback have shown promise in treating various psychological conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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
Where this trial is running
Philadelphia, Pennsylvania
- Center for Neuromodulation in Depression and Stress — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Yvette I Sheline, MD — University of Pennsylvania
- Study coordinator: Frederick Nitchie
- Email: frederick.nitchie@pennmedicine.upenn.edu
- Phone: (215) 573-9058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.