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Sensory Motor Arousal Regulation Treatment (SMART) Study

The Effects of Sensory Motor Arousal Regulation Treatment (SMART) on Adults With PTSD

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06035809
Acronym
SMART
Enrollment
80
Registered
2023-09-13
Start date
2026-04-15
Completion date
2028-04-15
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD, Post-traumatic Stress Disorder

Keywords

PTSD, Post-traumatic Stress Disorder, Body-based trauma therapy, Movement-based trauma therapy, Sensory-motor

Brief 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.

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.

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.

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Assessors will be blinded to which treatment arm a participant was assigned.

Intervention model description

This is a study investigating SMART as an intervention for symptoms of PTSD. Participants will be randomized to one of two conditions: SMART or Wait List (i.e., delayed treatment), and both groups will be assessed at 3 time points.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Clinician Administered PTSD Scale (CAPS) score from pre-treatment to post-treatment assessment.8 weeksGold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms
Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment.12 weeksGold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms

Secondary

MeasureTime frameDescription
Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from pre-treatment to post-treatment assessment.8 weeksA 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.
Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from post-treatment to 3-month follow-up assessment.12 weeksA 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.

Countries

Canada

Contacts

CONTACTSuzy - Coordinator
suzy.southwell@lhsc.on.ca519-685-8500
PRINCIPAL_INVESTIGATORRuth Lanius, MD, PhD

Lawson Health Research/Western University/LHSC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026