Sensory Motor Arousal Regulation Treatment (SMART) Study

PTSD Clinical Trial

— SMART  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06035809
• Other study ID #: ReDA: 12919
• Secondary ID: 121855
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2024
• Source: Lawson Health Research Institute
• Contact: Suzy - Coordinator
• Phone: 519-685-8500
• Email: suzy.southwell[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre - University Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from pre-treatment to post-treatment assessment.	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
Secondary	Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from post-treatment to 3-month follow-up assessment.	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