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Sensory Motor Arousal Regulation Treatment (SMART) Study (SMART)

Primary Purpose

PTSD, Post-traumatic Stress Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SMART
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, Post-traumatic Stress Disorder, Body-based trauma therapy, Movement-based trauma therapy, Sensory-motor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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 history of any pervasive developmental disorder lifetime bipolar or psychotic disorder alcohol/substance abuse or dependence within the last 3 months extensive narcotic use (e.g., fentanyl, oxycodone, etc.) anyone who would not be suitable for short-term treatment (as determined by our pre-treatment assessment) suicide attempt in last 6 months

Sites / Locations

  • London Health Sciences Centre - University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active SMART

Wait List

Arm 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.

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).

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.
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.
Change in Sensory-Motor function as assessed by Sensory-Motor assessment from pre-treatment to post-treatment assessment.
Practical assessment of tactile, vestibular and proprioceptive abilities.

Full Information

First Posted
September 6, 2023
Last Updated
September 18, 2023
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT06035809
Brief Title
Sensory Motor Arousal Regulation Treatment (SMART) Study
Acronym
SMART
Official Title
The Effects of Sensory Motor Arousal Regulation Treatment (SMART) on Adults With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Post-traumatic Stress Disorder
Keywords
PTSD, Post-traumatic Stress Disorder, Body-based trauma therapy, Movement-based trauma therapy, Sensory-motor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Assessors will be blinded to which treatment arm a participant was assigned.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active SMART
Arm Type
Experimental
Arm 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.
Arm Title
Wait List
Arm Type
No Intervention
Arm 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).
Intervention Type
Behavioral
Intervention Name(s)
SMART
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Clinician Administered PTSD Scale (CAPS) score from pre-treatment to post-treatment assessment.
Description
Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms
Time Frame
8 weeks
Title
Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment.
Description
Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from pre-treatment to post-treatment assessment.
Description
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
Title
Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from post-treatment to 3-month follow-up assessment.
Description
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
Title
Change in Sensory-Motor function as assessed by Sensory-Motor assessment from pre-treatment to post-treatment assessment.
Description
Practical assessment of tactile, vestibular and proprioceptive abilities.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 history of any pervasive developmental disorder lifetime bipolar or psychotic disorder alcohol/substance abuse or dependence within the last 3 months extensive narcotic use (e.g., fentanyl, oxycodone, etc.) anyone who would not be suitable for short-term treatment (as determined by our pre-treatment assessment) suicide attempt in last 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzy - Coordinator
Phone
519-685-8500
Ext
35186
Email
suzy.southwell@lhsc.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Lanius, MD, PhD
Organizational Affiliation
Lawson Health Research/Western University/LHSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only coded data will be shared with co-investigators who are registered with the study's ethics board application.
Citations:
PubMed Identifier
32318157
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.
Results Reference
background
PubMed Identifier
25854674
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.
Results Reference
background
PubMed Identifier
28911803
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.
Results Reference
background
PubMed Identifier
33178406
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.
Results Reference
background
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.
Results Reference
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Sensory Motor Arousal Regulation Treatment (SMART) Study

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