NCT06035809

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
22mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026Apr 2028

First Submitted

Initial submission to the registry

September 6, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
2.6 years until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2028

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

September 6, 2023

Last Update Submit

April 17, 2026

Conditions

PTSDPost-traumatic Stress Disorder

Keywords

PTSDPost-traumatic Stress DisorderBody-based trauma therapyMovement-based trauma therapySensory-motor

Outcome Measures

Primary Outcomes (2)

  • 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

    8 weeks

  • 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

    12 weeks

Secondary Outcomes (2)

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

    8 weeks

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

    12 weeks

Study Arms (2)

Active SMART

EXPERIMENTAL

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

Wait List

NO INTERVENTION

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

SMARTBEHAVIORAL

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.

Active SMART

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre - University Hospital

London, Ontario, N6A 5A5, Canada

RECRUITING

Related Publications (5)

  • 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.

    PMID: 32318157BACKGROUND

  • 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.

    PMID: 25854674BACKGROUND

  • 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.

    PMID: 28911803BACKGROUND

  • 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.

    PMID: 33178406BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Ruth Lanius, MD, PhD

    Lawson Health Research/Western University/LHSC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzy - Coordinator

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors will be blinded to which treatment arm a participant was assigned.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor of Psychiatry, Harris-Woodman Chair, University of Western Ontario

Study Record Dates

First Submitted

September 6, 2023

First Posted

September 13, 2023

Study Start

April 15, 2026

Primary Completion (Estimated)

April 15, 2028

Study Completion (Estimated)

April 15, 2028

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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

Locations

CA(1)