Sensory Motor Arousal Regulation Treatment (SMART) Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults, aged 18-65

A primary diagnosis of PTSD as determined by our pre-treatment assessment

Ability to provide informed consent

Fluency in written and spoken English (to be able to complete assessments)

Disqualifiers

any implants, conditions, etc. that do not comply with 7T (Tesla) fMRI research safety standards (e.g., pacemaker, pregnancy/possible pregnancy)

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)

significant untreated medical illness

history of neurological or neurodevelopmental disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • SMART

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Active SMARTExperimental treatment 1 intervention
Group B: Wait ListNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
8 weeks
2

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

Time frame
12 weeks

Secondary outcomes

1

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.

Time frame
8 weeks
2

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.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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