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RecruitingNCT06035809SMARTUpdated Apr 22, 2026

Sensory Motor Arousal Regulation Treatment (SMART) Study

An interventional study of SMART in PTSD and Post-traumatic Stress Disorder, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

This study will investigate whether a movement and body-based treatment can benefit adults with Post-traumatic Stress Disorder (PTSD). The treatment is called Sensory Motor Arousal Regulation Treatment, or "SMART", and study participation involves 8 sessions of SMART, as well as pre-treatment, post-treatment, and 3-month follow-up assessments.

Read the detailed description

This study will investigate the use of SMART (Sensory Motor Arousal Regulation Treatment) with adults experiencing symptoms related to PTSD (Post-Traumatic Stress Disorder). In addition to the more well-known symptoms of PTSD (e.g., intrusive memories, avoidance, hypervigilance, and emotion dysregulation), chronic traumatic stress seems to overwhelm the brain's capacity to make sense of sensory information, affecting how traumatized people experience their own bodies and their surroundings. SMART builds on the sensory integration theory of intentionally engaging the senses via movement, touch, body awareness, and balance. The SMART protocol has been used effectively to treat children who have experienced psychological trauma, and the investigators will be investigating its use with adults. Participants enrolled in the study will be randomly assigned to one of two treatment conditions - i) SMART, or ii) wait list (i.e., delayed treatment). Study participation will involve 8, 1-hour sessions of SMART, as well as pre-treatment, post-treatment, and 3-month follow-up assessments. For those assigned to the wait list condition, the same 8 SMART sessions will be offered after the 3-month follow-up assessment is complete, with no further assessment required.

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Conditions studied

  • PTSD
  • Post-traumatic Stress Disorder

Keywords

  • PTSD
  • Post-traumatic Stress Disorder
  • Body-based trauma therapy
  • Movement-based trauma therapy
  • Sensory-motor
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In context

Stress Disorders, Post-Traumatic

2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 553 are open to participants now.

This study's planned enrollment of 80 is above the median of 70 across 1,856 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 309 studies on the registry; 126 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adults, aged 18-65
  2. A primary diagnosis of PTSD as determined by our pre-treatment assessment
  3. Ability to provide informed consent
  4. Fluency in written and spoken English (to be able to complete assessments)
  5. Lives within 30km of London, ON

Exclusion criteria

Exclusion Criteria:

  1. any implants, conditions, etc. that do not comply with 7T (Tesla) fMRI research safety standards (e.g., pacemaker, pregnancy/possible pregnancy)
  2. history of significant head injury/lengthy loss of consciousness (e.g., a Glasgow Coma Scale Score \< 15 at the time of incident as assessed retrospectively by participant)
  3. significant untreated medical illness
  4. history of neurological or neurodevelopmental disorder
  5. history of any pervasive developmental disorder
  6. lifetime bipolar or psychotic disorder
  7. alcohol/substance abuse or dependence within the last 3 months
  8. extensive narcotic use (e.g., fentanyl, oxycodone, etc.)
  9. anyone who would not be suitable for short-term treatment (as determined by our pre-treatment assessment)
  10. suicide attempt in last 6 months
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Active SMART

    Participants in the active SMART condition will complete 8 individual, 1-hour, weekly sessions of SMART with a therapist, as well as pre-treatment, post-treatment and 3-month follow-up assessments.

    Behavioral: SMART

  • No intervention
    Wait List

    Participants in the Wait List condition will receive no treatment for approximately 8 weeks, and they will be asked to complete pre-wait list, post-wait list and 3-month follow-up assessments. After all assessments have been completed, this group will be offered the same 8 individual, 1-hour, weekly sessions of SMART (no further assessments needed).

Interventions

  • BehavioralSMART

    A movement and body-based intervention in which participants are encouraged to explore the use of sensory equipment, which may help reduce symptoms related to psychological trauma/PTSD. Sensory equipment includes exercise balls, mini-trampoline, weighted blankets, and a hammock swing.

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What researchers measure

Primary outcomes

  1. Change in Clinician Administered PTSD Scale (CAPS) score from pre-treatment to post-treatment assessment.

    Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms

    Time frame: 8 weeks

  2. Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment.

    Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms

    Time frame: 12 weeks

Secondary outcomes

  1. Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from pre-treatment to post-treatment assessment.

    A state-trait, self-report questionnaire with 32 items to measure multiple dimensions of interoception (e.g., awareness of the senses). Higher scores indicate beneficial self-reported interoception.

    Time frame: 8 weeks

  2. Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from post-treatment to 3-month follow-up assessment.

    A state-trait, self-report questionnaire with 32 items to measure multiple dimensions of interoception (e.g., awareness of the senses). Higher scores indicate beneficial self-reported interoception.

    Time frame: 12 weeks

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Study locations

1 of 1 sites recruiting
  • London Health Sciences Centre - University Hospital
    London, Ontario N6A 5A5, Canada
    • Suzy -Study Coordinator · Contact · suzy.southwell@lhsc.on.ca · 519-685-8500
    • Ruth Lanius, MD, PhD · Principal investigator
    Recruiting
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References and documents

Publications

  • Finn H, Warner E, Price M, Spinazzola J. The Boy Who Was Hit in the Face: Somatic Regulation and Processing of Preverbal Complex Trauma. J Child Adolesc Trauma. 2017 Jun 29;11(3):277-288. doi: 10.1007/s40653-017-0165-9. eCollection 2018 Sep. PubMed 32318157 ↗
  • Lanius RA, Frewen PA, Tursich M, Jetly R, McKinnon MC. Restoring large-scale brain networks in PTSD and related disorders: a proposal for neuroscientifically-informed treatment interventions. Eur J Psychotraumatol. 2015 Mar 31;6:27313. doi: 10.3402/ejpt.v6.27313. eCollection 2015. PubMed 25854674 ↗
  • Harricharan S, Nicholson AA, Densmore M, Theberge J, McKinnon MC, Neufeld RWJ, Lanius RA. Sensory overload and imbalance: Resting-state vestibular connectivity in PTSD and its dissociative subtype. Neuropsychologia. 2017 Nov;106:169-178. doi: 10.1016/j.neuropsychologia.2017.09.010. Epub 2017 Sep 11. PubMed 28911803 ↗
  • Lanius RA, Terpou BA, McKinnon MC. The sense of self in the aftermath of trauma: lessons from the default mode network in posttraumatic stress disorder. Eur J Psychotraumatol. 2020 Oct 23;11(1):1807703. doi: 10.1080/20008198.2020.1807703. PubMed 33178406 ↗
  • Warner, E., Westcott, A., Cook, A., & Finn, H. (2020). Transforming trauma in children and adolescents: An embodied approach to somatic regulation, trauma processing, and attachment-building. North Atlantic Books.

Individual participant data

Plan to share: No — Only coded data will be shared with co-investigators who are registered with the study's ethics board application.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06035809
Lead sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Responsible party
Ruth Lanius (MD, PhD, Professor of Psychiatry, Harris-Woodman Chair, University of Western Ontario, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's) — Principal investigator
First posted
Sep 13, 2023
Start date
Apr 15, 2026
Primary completion
Apr 15, 2028 (estimated)
Completion
Apr 15, 2028 (estimated)
Last update
Apr 22, 2026

Study contacts

Suzy - Coordinator
Contact
suzy.southwell@lhsc.on.ca
519-685-8500 ext. 35186
Ruth Lanius, MD, PhD
principal investigator · Lawson Health Research/Western University/LHSC

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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