Clinical trial NCT06035809: Sensory Motor Arousal Regulation Treatment (SMART) Study
Official title: The Effects of Sensory Motor Arousal Regulation Treatment (SMART) on Adults With PTSD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PTSD
Post-traumatic Stress Disorder
Keywords: PTSD
Post-traumatic Stress Disorder
Body-based trauma therapy
Movement-based trauma therapy
Sensory-motor
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Clinician Administered PTSD Scale (CAPS) score from pre-treatment to post-treatment assessment.
timeFrame: 8 weeks
measure: Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from pre-treatment to post-treatment assessment.
timeFrame: 8 weeks
measure: Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from post-treatment to 3-month follow-up assessment.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
Study officials:
affiliation: Lawson Health Research/Western University/LHSC
name: Ruth Lanius, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.