Rapid Entrainment and Signal-guided Neuromodulation for Behavioral Health

RESYNC-BH is a research study evaluating a personalized, non-drug brain-and-body treatment approach for adults with ongoing behavioral health symptoms such as depression, anxiety, trauma-related symptoms, sleep problems, attention difficulties, or substance-use concerns. Rather than assigning treatment solely according to psychiatric diagnosis, treatment approaches are selected based on symptoms, physiologic measures, and clinical presentation. Treatment may include noninvasive neuromodulation, sensory stimulation, regulated breathing, and AIP-informed integrative psychotherapy. The study will evaluate whether personalized treatment approaches produce rapid and sustained improvements in behavioral health symptoms and functioning, and whether treatment response is accompanied by measurable changes in neurophysiologic, autonomic, cognitive, inflammatory, and behavioral measures. The study hypothesis is that meaningful clinical improvement is associated with measurable changes across brain, body, cognitive, and behavioral signals, and that early changes in these measures may help characterize treatment response and its durability. The long-term goal is to develop more objective and personalized methods for monitoring behavioral health treatment response.

Inclusion Criteria: * Age 18 to 70 years at the time of consent * Able to understand the study and provide signed informed consent * Willing and able to comply with study procedures and follow-up assessments for approximately 12 months * Presence of clinically significant behavioral-health symptoms and/or functional impairment in at least one of the following domains, as determined by clinical interview and standardized measures: * Depressive symptoms * Anxiety symptoms * Trauma- and stressor-related symptoms * Substance-related symptoms not requiring immediate detoxification * Attentional/impulsivity or executive-function symptoms * A formal DSM-5 diagnosis is not required if symptoms and impairment are clinically meaningful and appropriate for outpatient behavioral-health intervention * Medically stable, in the judgment of the investigator, for outpatient behavioral-health treatment and applicable noninvasive neuromodulation or multisensory entrainment * If taking psychotropic or other relevant medications, on a stable dose for at least 4 weeks before baseline, with no planned changes during the acute intervention phase except as clinically necessary * Sufficient proficiency in English or another IRB-approved language to understand study procedures and provide informed consent, with approved translated materials or interpreter support when available * If of reproductive potential, agrees to applicable pregnancy-prevention requirements during the acute intervention phase * Willing to follow study lifestyle and safety requirements, including restrictions on alcohol and substance use before study sessions and applicable post-session safety recommendations Exclusion Criteria: * History of seizure disorder or other condition that, in the investigator's judgment, would make exposure to stroboscopic or patterned light stimulation unsafe * Severe photosensitivity or light sensitivity that could be worsened by exposure to flashing or patterned light * Implanted electronic or other medical device that is incompatible with study neuromodulation procedures * Unstable or clinically significant cardiovascular, neurologic, or other medical condition that could make study participation unsafe * Unstable or high-risk psychiatric condition, including: * Recent suicide attempt or current imminent suicide risk * Active psychosis * Uncontrolled mania or other acute psychiatric instability requiring a higher level of care * Pregnant or breastfeeding at screening or during participation * Acute intoxication or inability/unwillingness to comply with study safety restrictions regarding alcohol or non-prescribed/recreational substance use before study sessions * Unstable or rapidly changing psychotropic medication regimen at baseline * Concurrent participation in another interventional trial targeting behavioral health or neuromodulation that, in the investigator's judgment, would confound study outcomes or create a safety concern * Any other medical, psychiatric, cognitive, or behavioral condition that, in the investigator's judgment, would prevent safe participation or meaningful completion of study procedures