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Recruiting Not applicable NCT06035809

Sensory Motor Arousal Regulation Treatment (SMART) Study

No applicable phase (e.g. observational)
Conditions: PTSD Post-traumatic Stress Disorder

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

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
SMART
BEHAVIORAL
Locations 1
Canada (1)
London Health Sciences Centre - University Hospital
London , Ontario
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
15.04.2026
Completion date
15.04.2028
Registry ID
NCT06035809
Source
clinicaltrials.gov
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