Recruiting

SMART

Sponsor:

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

Code:

NCT06035809

Conditions

PTSD

Post-traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

SMART

Study Details

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.

Conditions

PTSD

Post-traumatic Stress Disorder

Study ID

NCT06035809

Start date

Apr 15, 2026

Status verified date

Apr, 2026

Completion date

Apr 15, 2028

Anticipated

Primary completion date

Apr 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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

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.

Primary outcome measure

  • Change in Clinician Administered PTSD Scale (CAPS) score from pre-treatment to post-treatment assessment. [ Time Frame: 8 weeks ]
  • Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment. [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Suzy - Coordinator

519-685-8500suzy.southwell@lhsc.on.ca

Locations

London Health Sciences Centre - University Hospital

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Suzy -Study Coordinator

519-685-8500suzy.southwell@lhsc.on.ca

Principal Investigator:

Ruth Lanius, MD, PhD

More Information

Sponsor

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

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2026-04-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.