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Sensory Motor Arousal Regulation Treatment (SMART) Study

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06035809
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SMART
 N/A

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 we 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
Single (Outcomes Assessor)
Masking Description:
Assessors will be blinded to which treatment arm a participant was assigned.
Primary Purpose:
Treatment
Official Title:
The Effects of Sensory Motor Arousal Regulation Treatment (SMART) on Adults With PTSD
Anticipated Study Start Date :
Sep 30, 2023
Anticipated Primary Completion Date :
Sep 30, 2025
Anticipated Study Completion Date :
Sep 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active SMART

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.

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.
No Intervention: Wait List

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).

Outcome Measures

Primary Outcome Measures

  1. Change in Clinician Administered PTSD Scale (CAPS) score from pre-treatment to post-treatment assessment. [8 weeks]

    Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms

  2. Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment. [12 weeks]

    Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms

Secondary Outcome Measures

  1. Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from pre-treatment to post-treatment assessment. [8 weeks]

    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.

  2. Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from post-treatment to 3-month follow-up assessment. [12 weeks]

    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.

  3. Change in Sensory-Motor function as assessed by Sensory-Motor assessment from pre-treatment to post-treatment assessment. [8 weeks]

    Practical assessment of tactile, vestibular and proprioceptive abilities.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 London Health Sciences Centre - University Hospital London Ontario Canada N6A 5A5

Sponsors and Collaborators

  • Lawson Health Research Institute

Investigators

  • Principal Investigator: Ruth Lanius, MD, PhD, Lawson Health Research/Western University/LHSC

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ruth Lanius, MD, PhD, Professor of Psychiatry, Harris-Woodman Chair, University of Western Ontario, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT06035809
Other Study ID Numbers:
  • ReDA: 12919
  • 121855
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ruth Lanius, MD, PhD, Professor of Psychiatry, Harris-Woodman Chair, University of Western Ontario, Lawson Health Research Institute
PTSD
Post-traumatic Stress Disorder
Body-based trauma therapy
Movement-based trauma therapy
Sensory-motor
Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Sep 13, 2023