An interventional study of AIP-Informed Integrative Psychotherapy and Transcutaneous Auricular Vagus Nerve Stimulation in Anxiety, PTSD and ADHD, sponsored by Tactical Mind Research Coalition, Inc.. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Tactical Mind Research Coalition, Inc. · Not applicable, Interventional, and Treatment
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.
RESYNC-BH is a prospective, adaptive, transdiagnostic behavioral health study evaluating a personalized intervention platform (PRESET-Rx) and multimodal measures of treatment response. The study examines rapid within-session changes and longitudinal changes in neurophysiologic, autonomic, cognitive, inflammatory, and behavioral measures.
Participants receive a personalized combination of noninvasive neuromodulation and AIP-informed integrative psychotherapy based on baseline symptoms, physiologic measures, and clinical presentation. Study interventions may include noninvasive brain or peripheral nerve stimulation, regulated breathing, sensory stimulation using light, sound or vibration, and related noninvasive techniques. Treatment assignment and adaptation occur according to prespecified study criteria.
Multimodal assessments include EEG/qEEG, fNIRS, heart rate and heart rate variability, cognitive testing, standardized behavioral health measures, and inflammatory biomarkers. Selected sessions include simultaneous clinician-participant physiologic recording to evaluate therapeutic dyad dynamics. Optional data from compatible personal wearable devices may also be collected to characterize sleep, activity, and related physiologic patterns outside the clinic.
The acute treatment phase consists of approximately six structured sessions over 4-6 weeks, followed by longitudinal assessments of treatment response and durability.
Some participants may independently receive ketamine as part of routine clinical care. Ketamine is not a study intervention and is not assigned, initiated, scheduled, administered, or modified by the study. Ketamine exposure is recorded as a concomitant clinical treatment and may be considered in study analyses.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 240 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →This is the only study on the registry with Tactical Mind Research Coalition, Inc. as lead sponsor.
Compared within Stress Disorders, Post-Traumatic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Unstable or high-risk psychiatric condition, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: AIP-Informed Integrative Psychotherapy · Device: Transcutaneous Auricular Vagus Nerve Stimulation · Behavioral: Regulated Breathing and Autonomic Regulation · Behavioral: Breathwork-Based Auditory Driving Entropy Module (BADEM)
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.
Behavioral: AIP-Informed Integrative Psychotherapy · Device: Audiovisual Entrainment · Device: Vibroacoustic Stimulation · Behavioral: Breathwork-Based Auditory Driving Entropy Module (BADEM)
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.
Behavioral: AIP-Informed Integrative Psychotherapy · Behavioral: Breathwork-Based Auditory Driving Entropy Module (BADEM) · Device: Transcranial Electrical Stimulation
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
A structured psychotherapy approach based on the Adaptive Information Processing (AIP) model, incorporating EMDR-informed techniques and other evidence-based psychotherapeutic strategies as clinically appropriate. The intervention is delivered as part of PRESET-Rx sessions to support processing and integration.
Also known as: EMDR, Adaptive Information Processing-informed psychotherapy
Noninvasive transcutaneous auricular vagus nerve stimulation delivered through cutaneous ear electrodes according to prespecified protocol and safety parameters.
Also known as: TaVNS
Structured breathing and related autonomic-regulation practices delivered according to prespecified protocol procedures.
Noninvasive patterned visual and auditory stimulation delivered according to prespecified protocol procedures as part of PRESET-Rx sessions.
Also known as: AVE, patterned light and auditory entrainment
Noninvasive mechanical vibration delivered through a vibroacoustic surface according to prespecified protocol procedures. This intervention may be used selectively based on protocol-defined clinical and safety considerations.
Also known as: Vibroacoustic entrainment, tactile acoustic stimulation
A structured, time-limited breathwork and auditory stimulation procedure that may be used selectively according to prespecified protocol and safety criteria.
Noninvasive low-intensity transcranial electrical stimulation delivered through scalp electrodes according to prespecified protocol and safety parameters.
Also known as: tES, transcranial electrical neuromodulation
Change in RESYNC Index Composite Score
The RESYNC Index is a standardized, unitless multimodal composite score designed to summarize treatment-related change across prespecified clinical/behavioral, autonomic, neurophysiologic, cognitive, and biomarker measures. The outcome is change from baseline in RESYNC Index score during the acute treatment phase and longitudinal follow-up. The index is interpreted according to the prespecified scoring framework, with change in score representing the magnitude and direction of multimodal treatment response. Unit of Measure: Standardized unitless composite score
Time frame: Baseline through 12 months
Clinician-Participant Heart Rate Variability Synchrony
Physiologic synchrony between the participant and clinician is assessed using simultaneous heart rate and heart rate variability (HRV) recordings obtained during selected treatment sessions. The outcome is a unitless HRV synchrony coefficient representing the degree of physiologic coupling between clinician and participant; higher values indicate greater synchrony. Unit of Measure: Unitless HRV synchrony coefficient
Time frame: Selected treatment sessions during the 6-week acute intervention phase
Clinician-Participant EEG Synchrony
Neural synchrony between the participant and clinician is assessed using simultaneous EEG recordings obtained during selected treatment sessions. The outcome is a unitless EEG synchrony coefficient representing the degree of inter-brain coupling between clinician and participant; higher values indicate greater synchrony. Unit of Measure: Unitless EEG synchrony coefficient
Time frame: Selected treatment sessions during the 6-week acute intervention phase
Clinician-Participant Electrodermal Activity Coupling
Electrodermal coupling will be calculated from simultaneous participant and clinician electrodermal activity recordings during selected sessions using a prespecified time-series coupling metric. Unit of Measure: Unitless coupling coefficient
Time frame: Selected treatment sessions during the 6-week acute intervention phase
Correlation Between Clinician-Participant EEG Synchrony and Acute Change in RESYNC Index
This outcome assesses the association between clinician-participant EEG synchrony measured during the acute treatment phase and change from baseline in the RESYNC Index at the end of acute treatment. The reported outcome is a correlation coefficient ranging from -1 to +1, where values farther from 0 indicate a stronger association and the sign indicates the direction of the relationship. Unit of Measure: Correlation coefficient
Time frame: EEG synchrony assessed during prespecified dyadic sessions through Week 6; RESYNC Index assessed at baseline and Week 6.
Change in Patient Health Questionnaire-9 Score
Depressive symptom severity will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report measure. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity. The outcome is change in PHQ-9 total score from baseline over the acute intervention phase and follow-up period. Unit of Measure: Points on the PHQ-9 scale
Time frame: Baseline; prior to treatment sessions during Weeks 1-6; and follow-up at 1, 3, 6, and 12 months
Change in Generalized Anxiety Disorder-7 Score
Anxiety symptom severity will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report measure. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity. The outcome is change in GAD-7 total score from baseline over the acute intervention phase and follow-up period. Unit of Measure: Points on the GAD-7 scale
Time frame: Baseline; prior to treatment sessions during Weeks 1-6; and follow-up at 1, 3, 6, and 12 months
Change in PTSD Checklist for DSM-5 Score
Post-traumatic stress symptom severity will be assessed using the PTSD Checklist for DSM-5 (PCL-5), a 20-item self-report measure. Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity. The outcome is change in PCL-5 total score from baseline over the acute intervention phase and follow-up period. Unit of Measure: Points on the PCL-5 scale
Time frame: Baseline; prior to treatment sessions during Weeks 1-6; and follow-up at 1, 3, 6, and 12 months
Change in Depression Anxiety Stress Scales-8 Score
Global psychological distress will be assessed using the Depression Anxiety Stress Scales-8 (DASS-8), an 8-item self-report measure assessing depression, anxiety, and stress symptoms. Higher total scores indicate greater overall psychological distress. The outcome is change in DASS-8 total score from baseline over the acute intervention phase and follow-up period. Unit of Measure: Points on the DASS-8 scale
Time frame: Baseline; prior to treatment sessions during Weeks 1-6; and follow-up at 1, 3, 6, and 12 months
Within-Session Change in EEG Spectral Power
This outcome measures percent change in participant EEG spectral power from the pre-session recording period to the post-session recording period during each acute treatment session. EEG spectral power is derived from quantitative EEG recordings, with positive or negative values indicating the direction of change from the pre-session value. Unit of Measure: Percent change
Time frame: Immediately before and immediately after each of the 6 acute treatment sessions, over approximately 6 weeks
Within-Session Change in Heart Rate Variability
This outcome measures change in participant heart rate variability (HRV) from the pre-session recording period to the post-session recording period during each acute treatment session. HRV is quantified using root mean square of successive differences (RMSSD) derived from heart-rate recordings; positive or negative values indicate the direction of change from the pre-session value. Unit of Measure: Milliseconds (RMSSD)
Time frame: Immediately before and immediately after each of the 6 acute treatment sessions, once per week over approximately 6 weeks
Within-Session Change in Electrodermal Activity
This outcome measures change in participant electrodermal activity (EDA) from the pre-session recording period to the post-session recording period during each acute treatment session. EDA is measured as skin conductance in microsiemens (µS); positive or negative values indicate the direction of change from the pre-session value. Unit of Measure: microsiemens (µS)
Time frame: Immediately before and immediately after each of the 6 (weekly) acute treatment sessions, over approximately 6 weeks
Plan to share: Undecided — This is currently a privately-funded study and unsupported by a private or Federal grant. Data sharing could change based on funding availability.
Started Aug 2026 (actual). Primary completion is estimated for Jun 2028, 22 months after the start.
Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 22 months is below that.
Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic →