Sensory Motor Arousal Regulation Treatment (SMART) Study

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

Status: Begins enrollment this month

Conditions: Post-traumatic Stress Disorder; PTSD

Treatments: Behavioral: SMART

Study type: Interventional

Funder types: Other

Identifiers

NCT06035809

ReDA: 12919

121855 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Active SMART

Experimental group

Description:

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.

Treatment:

Behavioral: SMART

Wait List

No Intervention group

Description:

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).