The STRENGTHEN Study

Exclusion Criteria27

• Any current or recent history (6 months) of any mental health diagnosis (Examples include major depression, hypomania, psychosis, schizophrenia, and bipolar disorder)
• Any current or recent (past 6 months) history of treatment for mental illness (including anti-depressant/anti anxiety medications, therapy)
• Scoring above Moderate range for Anxiety or Depression - Patient Health Questionnaire-9 (PHQ-9) greater than or equal to 15 or General Anxiety Disorder (GAD7) greater than or equal to 15
• At risk for suicide (PHQ item 9 greater than 0)
• Any current or past history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions and obstructive sleep apnea
• History of head trauma resulting in prolonged loss of consciousness; or a history of greater than 3 grade I concussions
• Current history of poorly controlled headaches including intractable or poorly controlled migraines
• Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
• History of fainting spells of unknown or undetermined etiology that might constitute seizures
• History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) electroencephalogram, or family history of treatment resistant epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
• Possible pregnancy or plan to become pregnant in the next 6 months.
• Any metal in the brain, skull or elsewhere
• Any hair braid, dreadlocks, hair pieces, or extensions which cannot be taken out before the MRI scans and/or sleep stimulation sessions
• Any head coverings or headdress that participant feels uncomfortable removing for the purposes of the MRI scans and/or sleep stimulation sessions
• Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible physician
• Dental implants containing metal (titanium or titanium alloys) surgically implanted post and core
• Substance use disorder within the past six months
• Any medication that may alter seizure threshold i.e., Attention-deficit/hyperactivity disorder (ADHD) stimulants (Adderall, amphetamine); Tricyclic/atypical antidepressants (amitriptyline, doxepine, imipramine, maprotiline, nortriptyline, bupropion); Antipsychotics (chlorpromazine, clozapine), Bronchodilators (theophylline, aminophylline); Antibiotics (fluoroquinolones, imipenem, penicillin, cephalosporins, metronidazole, isoniazid); Antivirals (valacyclovir, ritonavir); Over the Counter (OTC) (diphenhydramine, Benadryl)
• Claustrophobia (a fear of small or closed places)
• Back problems that would prevent lying flat for up to two hours
• Regular night-shift work (second or third shift)
• Do not have access to a smartphone or the internet
• Regular meditation practice and/or prior use of the Healthy Minds Program app
• Cannot visit the lab in-person for 7 consecutive weeks in the next year
• Permanent retainers
• Any current or recent history (6 months) of bipolar disorder, psychosis, schizophrenia. A history of stable depression or anxiety is not exclusionary.
• Mental health treatment (e.g, psychotherapy) is no longer exclusionary, although all the medication exclusions outlined above still apply