Overview
The Clinical and Translational Science Institute of the University of Minnesota is hosting a clinical trial assessing transcranial direct current stimulation (tDCS) on mindful breathing techniques (MBT) for teens with depression. Researchers will attempt to use tDCS to connect circuits in the brain. They believe it will increase emotion regulation and decrease depression.
Study Information
The study has 4 goals:
- Aim 1: To show researchers’ ability to recruit adolescents with depression for the research study.
- Aim 2: To test tolerance of circuit stimulation in the brains of participants
- Aim 3: To examine whether tDCS can enhance the effects of MBT
- Aim 4: To examine the inner-workings of MBT with and without tDCS treatment
Inclusion Criteria
- All sexes, age 16 to 24 years old
- Diagnosis of major depressive disorder (MDD), Dysthymia, or Other specified/Unspecified Depressive Disorder
- Experiencing current symptoms of depression
- Ability to use the MBT online-based application on a personal laptop, tablet, or cell phone
Exclusion Criteria
- Any participant with a neurological disorder
- Any participant with an increased risk of seizure for any reason
- Participants with conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the head excluding the mouth that cannot safely be removed
- Participants with active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, and vagus nerve stimulators
- Participants with pre-existing sores or lesions where electrodes will be placed
- Any hairstyle that would prevent electrode contact (e.g., dreadlocks)
- Pregnant or possibly pregnant women
- Participants unable to give informed consent
- Participation in any investigational drug trial
- Clinically significant laboratory abnormality or medical condition that would hinder the participant in completing the study
- Currently actively suicidal
- A diagnosis of current or recent substance use disorder (within the past 12 months)
- A diagnosis of Schizophrenia, Bipolar Disorder, or Autism
- Unstable psychotherapy (therapy must be for at least 3 months prior to entry into the study)
- Recent dose change of antidepressant, antipsychiotic, or mood stabilizer medication (within 6 weeks prior to entry into the study)
- Refusal to cooperate with study procedures
Locations
The study is being held at the University of Minnesota in Minneapolis, Minnesota, 55455. If you have any questions feel free to contact Michelle Thai at 612-626-6870 or at umnteen@umn.edu.
Sponsors/Collaborators
This clinical trial is sponsored by Emory University and collaborated by the Clinical and Translational Science Institute of the University of Minnesota.
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