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RESYNC-BHNCT07812987

Rapid Entrainment and Signal-guided Neuromodulation for Behavioral Health

StatusActive, Not Recruiting
PhaseNot applicable
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Secondary endpoints: details revised at 3 of 8 entries
    • Study description shortened, about 225 words
  2. Study First Submitted
  • Minor: routine updates

Endpoints

Primary

Change in RESYNC Index Composite Score
Timeframe: Baseline through 12 months

Secondary (8)

Clinician-Participant Heart Rate Variability Synchrony
Clinician-Participant EEG Synchrony
Clinician-Participant Electrodermal Activity Coupling
Correlation Between Clinician-Participant EEG Synchrony and Acute Change in RESYNC Index
Change in Patient Health Questionnaire-9 Score
Show 3 moreShow less
Change in Generalized Anxiety Disorder-7 Score
Change in PTSD Checklist for DSM-5 Score
Change in Depression Anxiety Stress Scales-8 Score

Arms and interventions

Stack A - Autonomic Regulation + AIP-Informed Integrative PsychotherapyExperimental

Participants assigned to Stack A receive a PRESET-Rx intervention emphasizing autonomic regulation, combined with AIP-informed integrative psychotherapy. The intervention may include noninvasive peripheral neuromodulation, regulated breathing, and related autonomic-regulation techniques, with treatment delivered according to prespecified protocol criteria. Physiologic and neurophysiologic measures are collected during study sessions.

Stack B - Multisensory Entrainment + AIP-Informed Integrative PsychotherapyExperimental

Participants assigned to Stack B receive a PRESET-Rx intervention emphasizing multisensory state modulation, combined with AIP-informed integrative psychotherapy. The intervention may include noninvasive visual, auditory, and vibroacoustic stimulation, delivered according to prespecified protocol criteria. Physiologic and neurophysiologic measures are collected during study sessions.

Stack C - Transcranial Electrical Stimulation + AIP-Informed Integrative PsychotherapyExperimental

Participants assigned to Stack C receive a PRESET-Rx intervention emphasizing noninvasive cortical neuromodulation, combined with AIP-informed integrative psychotherapy. The intervention may include low-intensity transcranial electrical stimulation, delivered according to prespecified protocol criteria. Physiologic and neurophysiologic measures are collected during study sessions.

Stack D - AIP-Informed Integrative PsychotherapyActive comparator

Participants assigned to Stack D receive AIP-informed integrative psychotherapy without active neuromodulation or multisensory stimulation. Study assessments and physiologic/neurophysiologic measurements are performed according to the same study procedures used across intervention arms. Stack D serves as the active psychotherapy comparator.

Behavioral: AIP-Informed Integrative Psychotherapy, Regulated Breathing and Autonomic Regulation, Breathwork-Based Auditory Driving Entropy Module (BADEM)

Devices: Transcutaneous Auricular Vagus Nerve Stimulation, Audiovisual Entrainment, Vibroacoustic Stimulation, Transcranial Electrical Stimulation

Sites

1 site in 1 country

  • Tactical Mind Research CoalitionTampa, Florida, United States