Sensory Motor Arousal Regulation Treatment (SMART) Study (SMART)

April 17, 2026 updated by: Ruth Lanius, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • London Health Sciences Centre - University Hospital
        • Contact:
        • Principal Investigator:
          • Ruth Lanius, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment.
Time Frame: 12 weeks
Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms
12 weeks
Change in Clinician Administered PTSD Scale (CAPS) score from pre-treatment to post-treatment assessment.
Time Frame: 8 weeks
Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from pre-treatment to post-treatment assessment.
Time Frame: 8 weeks
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.
8 weeks
Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from post-treatment to 3-month follow-up assessment.
Time Frame: 12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Ruth Lanius, MD, PhD, Lawson Health Research/Western University/LHSC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2026

Primary Completion (Estimated)

April 15, 2028

Study Completion (Estimated)

April 15, 2028

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ReDA: 12919
  • 121855 (Other Identifier: Western Research Ethics Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only coded data will be shared with co-investigators who are registered with the study's ethics board application.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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