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NCT Number: NCT06035809

Sensory Motor Arousal Regulation Treatment (SMART) Study

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre - University Hospital

London, Ontario, N6A 5A5, Canada

Location status: Recruiting

Location contact

Ruth Lanius, MD, PhD

PRINCIPAL_INVESTIGATOR

Suzy -Study Coordinator

CONTACT

[email protected]

519-685-8500 ext. 35186

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • any implants, conditions, etc. that do not comply with 7T (Tesla) fMRI research safety standards (e.g., pacemaker, pregnancy/possible pregnancy)
  • 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)
  • significant untreated medical illness
  • history of neurological or neurodevelopmental disorder
  • history of any pervasive developmental disorder
  • lifetime bipolar or psychotic disorder
  • alcohol/substance abuse or dependence within the last 3 months
  • extensive narcotic use (e.g., fentanyl, oxycodone, etc.)
  • anyone who would not be suitable for short-term treatment (as determined by our pre-treatment assessment)
  • suicide attempt in last 6 months

Treatment and study plan

SMART

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Suzy - Coordinator

CONTACT

[email protected]

519-685-8500 ext. 35186

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: SMART

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 13, 2023
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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