← Back to Search

Behavioral Intervention

Biofeedback for Depression (Biofeedback Trial)

N/A
Recruiting
Led By Laurel Morris, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female aged 18-65 years
Meets DSM-5 criteria for major depressive disorder (MDD) as determined by the Structured Clinical Interview for DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI); with a current major depressive episode.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-training) and 2 hours (post-training) during the assessment visit
Awards & highlights

Biofeedback Trial Summary

This trial will test whether VTA self-modulation with biofeedback can improve depression symptoms in humans.

Who is the study for?
This trial is for adults aged 18-65 with major depressive disorder, as confirmed by specific interviews. They must understand English well enough to consent and participate in all study requirements. Excluded are those on CNS-active meds within the last week, drug abuse, pregnancy, involuntary psychiatric admission, certain other mental disorders or substance use issues in the past 6 months, and MRI contraindications like claustrophobia.Check my eligibility
What is being tested?
The trial tests whether real-time biofeedback targeting a brain area called VTA can help with depression symptoms. Participants will receive either active biofeedback (real feedback from their own brain signals) or sham biofeedback (fake feedback) while inside a high-resolution 7-Tesla MRI scanner.See study design
What are the potential side effects?
Since this intervention involves cognitive training without drugs or invasive procedures, side effects may be minimal but could include discomfort from lying still during MRI scans and potential psychological distress from focusing on personal mental health issues.

Biofeedback Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.
Select...
I have been diagnosed with major depression.
Select...
I am between 18 and 65 years old.

Biofeedback Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-training) and 2 hours (post-training) during the assessment visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-training) and 2 hours (post-training) during the assessment visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Increase in VTA Activation during MOTIVATE trials

Biofeedback Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active BiofeedbackExperimental Treatment1 Intervention
The patients in the active group will receive one active biofeedback training session.
Group II: Sham BiofeedbackPlacebo Group1 Intervention
The patients in the sham group will receive one sham biofeedback training session.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,416 Total Patients Enrolled
35 Trials studying Depression
4,369 Patients Enrolled for Depression
Laurel Morris, PhDPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai

Media Library

Active Biofeedback (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04138680 — N/A
Depression Research Study Groups: Active Biofeedback, Sham Biofeedback
Depression Clinical Trial 2023: Active Biofeedback Highlights & Side Effects. Trial Name: NCT04138680 — N/A
Active Biofeedback (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04138680 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Massachusetts
New York
How old are they?
18 - 65
What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'm pretty depressed these days and am seeking treatment because I don't want to be depressed all the time anymore.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Icahn School of Medicine at Mount Sinai: < 24 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
Email
Recent research and studies
clinicaltrials.govStudy
Real-time Biofeedback With 7-Tesla MRI for Treatment of Depression
Laurel Morris 2019. "Real-time Biofeedback With 7-Tesla MRI for Treatment of Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04138680.
All > Depression New York
~5 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top