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AnxietyRESYNC-BHNCT07812987

Rapid Entrainment and Signal-guided Neuromodulation for Behavioral Health

A study testing AIP-Informed Integrative Psychotherapy, Transcutaneous Auricular Vagus Nerve Stimulation and Regulated Breathing and Autonomic Regulation in people with Anxiety and PTSD, run by Tactical Mind Research Coalition, Inc. at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Anxiety, PTSD, ADHD
What is being tested?
AIP-Informed Integrative Psychotherapy, Transcutaneous Auricular Vagus Nerve Stimulation and Regulated Breathing and Autonomic Regulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteUnited States
Study dates
1 Aug 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Tactical Mind Research Coalition

    Tampa, Florida, 33618

Other trials in United States

About this study

Official title: Rapid Entrainment and Signal-guided Neuromodulation for Behavioral Health: A Transdiagnostic, Personalized Neuromodulation and Neuroimmune Study to Develop Objective Endpoints and Risk/Durability Profiles for Rapid-Acting Interventions (RESYNC-BH)

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.

Read the detailed description

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.

Being tested
AIP-Informed Integrative Psychotherapy, Transcutaneous Auricular Vagus Nerve Stimulation, Regulated Breathing and Autonomic Regulation, Audiovisual Entrainment, Vibroacoustic Stimulation
Keywords
neuroplasticity, audiovisual entrainment, biomarkers, inflammation, cognition, neuromodulation, multisensory entrainment, transcranial electrical stimulation, auricular vagus nerve stimulation, EMDR, Adaptive Information Processing, Predictive processing, Heart rate variability, EEG, fNIRS, Dyadic synchrony, therapeutic alliance, digital phenotyping, autonomic regulation, precision mental health
Medical subject headings
Anxiety Disorders, Stress Disorders, Post-Traumatic, Attention Deficit Disorder with Hyperactivity, Substance-Related Disorders, Parasomnias, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AIP-Informed Integrative PsychotherapyBehavioural

    Also called EMDR, Adaptive Information Processing-informed 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.

  • Transcutaneous Auricular Vagus Nerve StimulationDevice

    Also called TaVNS

    Noninvasive transcutaneous auricular vagus nerve stimulation delivered through cutaneous ear electrodes according to prespecified protocol and safety parameters.

  • Regulated Breathing and Autonomic RegulationBehavioural

    Structured breathing and related autonomic-regulation practices delivered according to prespecified protocol procedures.

  • Audiovisual EntrainmentDevice

    Also called AVE, patterned light and auditory entrainment

    Noninvasive patterned visual and auditory stimulation delivered according to prespecified protocol procedures as part of PRESET-Rx sessions.

  • Vibroacoustic StimulationDevice

    Also called Vibroacoustic entrainment, tactile acoustic stimulation

    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.

  • Breathwork-Based Auditory Driving Entropy Module (BADEM)Behavioural

    A structured, time-limited breathwork and auditory stimulation procedure that may be used selectively according to prespecified protocol and safety criteria.

  • Transcranial Electrical StimulationDevice

    Also called tES, transcranial electrical neuromodulation

    Noninvasive low-intensity transcranial electrical stimulation delivered through scalp electrodes according to prespecified protocol and safety parameters.

Study groups in NCT07812987
Study groupRoleWhat they receive
Stack A - Autonomic Regulation + AIP-Informed Integrative PsychotherapyExperimentalParticipants 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.
Receives: 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)
Stack B - Multisensory Entrainment + AIP-Informed Integrative PsychotherapyExperimentalParticipants 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.
Receives: Behavioral: AIP-Informed Integrative Psychotherapy; Device: Audiovisual Entrainment; Device: Vibroacoustic Stimulation; Behavioral: Breathwork-Based Auditory Driving Entropy Module (BADEM)
Stack C - Transcranial Electrical Stimulation + AIP-Informed Integrative PsychotherapyExperimentalParticipants 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.
Receives: Behavioral: AIP-Informed Integrative Psychotherapy; Behavioral: Breathwork-Based Auditory Driving Entropy Module (BADEM); Device: Transcranial Electrical Stimulation
Stack D - AIP-Informed Integrative PsychotherapyActive comparatorParticipants 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.
Receives: Behavioral: AIP-Informed Integrative Psychotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline through 12 months

Secondary outcomes (8)

  1. 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

    Measured: Selected treatment sessions during the 6-week acute intervention phase

  2. 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

    Measured: Selected treatment sessions during the 6-week acute intervention phase

  3. 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

    Measured: Selected treatment sessions during the 6-week acute intervention phase

  4. 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

    Measured: EEG synchrony assessed during prespecified dyadic sessions through Week 6; RESYNC Index assessed at baseline and Week 6.

  5. 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

    Measured: Baseline; prior to treatment sessions during Weeks 1-6; and follow-up at 1, 3, 6, and 12 months

  6. 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

    Measured: Baseline; prior to treatment sessions during Weeks 1-6; and follow-up at 1, 3, 6, and 12 months

  7. 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

    Measured: Baseline; prior to treatment sessions during Weeks 1-6; and follow-up at 1, 3, 6, and 12 months

  8. 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

    Measured: Baseline; prior to treatment sessions during Weeks 1-6; and follow-up at 1, 3, 6, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2026
  2. Study start1 Aug 2026
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
RESYNC-BH uses a Sequential Multiple Assignment Randomized Trial (SMART) design evaluating four predefined intervention approaches. Participants are initially randomized among intervention options determined to be appropriate based on prespecified clinical and physiologic criteria. Treatment response and safety are assessed during the acute intervention phase. At prespecified decision points, treatment may be continued or adapted according to protocol-defined response and safety criteria. Clinical safety considerations supersede randomization.
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07812987
Sponsor's protocol ID
26-01
Other IDs
TMRC 26-01
Acronym
RESYNC-BH
Status last verified
Sep 2026
First submitted
11 Dec 2025
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: This is currently a privately-funded study and unsupported by a private or Federal grant. Data sharing could change based on funding availability.

Publications

  • Chamberlin DE. The Predictive Processing Model of EMDR. Front Psychol. 2019 Oct 4;10:2267. doi: 10.3389/fpsyg.2019.02267. eCollection 2019.

    PubMed 31636594

  • FAA Mental Health ARC. (2024). MENTAL HEALTH ARC FINAL REPORT. Federal Aviation Administration

  • 11. VA Office of Mental Health and Suicide Prevention. (2024). NATIONAL VETERAN SUICIDE PREVENTION ANNUAL REPORT.

  • Carhart-Harris RL, Friston KJ. REBUS and the Anarchic Brain: Toward a Unified Model of the Brain Action of Psychedelics. Pharmacol Rev. 2019 Jul;71(3):316-344. doi: 10.1124/pr.118.017160.

    PubMed 31221820

Questions about this trial

What is this clinical trial studying?

A study testing AIP-Informed Integrative Psychotherapy, Transcutaneous Auricular Vagus Nerve Stimulation and Regulated Breathing and Autonomic Regulation in people with Anxiety and PTSD, run by Tactical Mind Research Coalition, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in RESYNC Index Composite Score (time frame: Baseline through 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07812987, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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