Sensory Motor Arousal Regulation Treatment (SMART) Study

NCT ID: NCT06035809

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-05
• Study Completion Date: 2028-01-05

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.

Conditions

PTSD; Post-traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

SMART

Intervention Type: 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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Ruth Lanius

MD, PhD, Professor of Psychiatry, Harris-Woodman Chair, University of Western Ontario

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruth Lanius, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lawson Health Research/Western University/LHSC

Locations

London Health Sciences Centre - University Hospital

London, Ontario, Canada

Countries

Canada

Central Contacts

Suzy - Coordinator

Role: CONTACT

suzy.southwell@lhsc.on.ca

519-685-8500 ext. 35186

References

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.

Reference Type: BACKGROUND

PMID: 32318157 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25854674 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28911803 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33178406 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

121855

Identifier Type: OTHER

Identifier Source: secondary_id

ReDA: 12919

Identifier Type: -

Identifier Source: org_study_id