CompletedNot Applicable

The STRENGTHEN Study

United States64 participantsStarted 2024-03-06

Plain-language summary

This study uses two different types of interventions including electrical brain stimulation delivered during sleep, and brief, daily meditation training. The investigators are trying to figure out whether these techniques, either alone or in combination with each other, can positively impact the brain networks that support our ability to think flexibly and to regulate our emotions. 48 participants will be enrolled into each of 2 phases and can expect to be on study for up to 9 months.

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria (Phase 1 and 2): * Medically healthy * English-speaking (able to provide consent and complete questionnaires) * Citizen or legal resident Exclusion Criteria (Phase 1): * 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 (epileptifo…

What they're measuring

Change in Patient Health Questionnaire-9 (PHQ-9) Score

Timeframe: baseline, visit 3 (week 1), visit 4 (week 1), visit 5 (week 2), visit 6 (week 2), visit 7 (week 3), visit 8 (week 3), visit 9 (week 4), visit 10 (week 4), post-intervention (week 5), follow-up (week 20)

Change in General Anxiety Disorder (GAD-7) Score

Change in Single-item Suicide Question

Change in Healthy Minds Index (HM Index)

Timeframe: baseline, post-intervention (week 5), follow-up (week 20)

Change in the Perceived Stress Scale (PSS) Score

Timeframe: baseline, post-intervention (week 5), follow-up (week 20)

Change in Emotional Styles Questionnaire (ESQ) Score

Timeframe: baseline, post-intervention (week 5), follow-up (week 20)

Trial details

NCT IDNCT06267521

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-24

View on ClinicalTrials.gov More Cognitive Flexibility trials

Plain-language summary

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Patient Health Questionnaire-9 (PHQ-9) Score

Change in General Anxiety Disorder (GAD-7) Score

Change in Single-item Suicide Question

Change in Healthy Minds Index (HM Index)

Timeframe: baseline, post-intervention (week 5), follow-up (week 20)

Change in the Perceived Stress Scale (PSS) Score

Timeframe: baseline, post-intervention (week 5), follow-up (week 20)

Change in Emotional Styles Questionnaire (ESQ) Score

Timeframe: baseline, post-intervention (week 5), follow-up (week 20)