xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06035809</url>
    </required_header>
    <id_info>
      <org_study_id>ReDA: 12919</org_study_id>
      <secondary_id>121855</secondary_id>
      <nct_id>NCT06035809</nct_id>
    </id_info>
    <brief_title>Sensory Motor Arousal Regulation Treatment (SMART) Study</brief_title>
    <acronym>SMART</acronym>
    <official_title>The Effects of Sensory Motor Arousal Regulation Treatment (SMART) on Adults With PTSD</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lawson Health Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Lawson Health Research Institute</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will investigate whether a movement and body-based treatment can benefit adults&#xD;
        with Post-traumatic Stress Disorder (PTSD). The treatment is called Sensory Motor Arousal&#xD;
        Regulation Treatment, or &quot;SMART&quot;, and study participation involves 8 sessions of SMART, as&#xD;
        well as pre-treatment, post-treatment, and 3-month follow-up assessments.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will investigate the use of SMART (Sensory Motor Arousal Regulation Treatment)&#xD;
        with adults experiencing symptoms related to PTSD (Post-Traumatic Stress Disorder). In&#xD;
        addition to the more well-known symptoms of PTSD (e.g., intrusive memories, avoidance,&#xD;
        hypervigilance, and emotion dysregulation), chronic traumatic stress seems to overwhelm the&#xD;
        brain's capacity to make sense of sensory information, affecting how traumatized people&#xD;
        experience their own bodies and their surroundings. SMART builds on the sensory integration&#xD;
        theory of intentionally engaging the senses via movement, touch, body awareness, and balance.&#xD;
        The SMART protocol has been used effectively to treat children who have experienced&#xD;
        psychological trauma, and we will be investigating its use with adults. Participants enrolled&#xD;
        in the study will be randomly assigned to one of two treatment conditions - i) SMART, or ii)&#xD;
        wait list (i.e., delayed treatment). Study participation will involve 8, 1-hour sessions of&#xD;
        SMART, as well as pre-treatment, post-treatment, and 3-month follow-up assessments. For those&#xD;
        assigned to the wait list condition, the same 8 SMART sessions will be offered after the&#xD;
        3-month follow-up assessment is complete, with no further assessment required.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <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.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Assessors will be blinded to which treatment arm a participant was assigned.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Clinician Administered PTSD Scale (CAPS) score from pre-treatment to post-treatment assessment.</measure>
      <time_frame>8 weeks</time_frame>
      <description>Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment.</measure>
      <time_frame>12 weeks</time_frame>
      <description>Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from pre-treatment to post-treatment assessment.</measure>
      <time_frame>8 weeks</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from post-treatment to 3-month follow-up assessment.</measure>
      <time_frame>12 weeks</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Sensory-Motor function as assessed by Sensory-Motor assessment from pre-treatment to post-treatment assessment.</measure>
      <time_frame>8 weeks</time_frame>
      <description>Practical assessment of tactile, vestibular and proprioceptive abilities.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>PTSD</condition>
    <condition>Post-traumatic Stress Disorder</condition>
    <arm_group>
      <arm_group_label>Active SMART</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Wait List</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <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).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>SMART</intervention_name>
      <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.</description>
      <arm_group_label>Active SMART</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adults, aged 18-65&#xD;
  &#xD;
            2. A primary diagnosis of PTSD as determined by our pre-treatment assessment&#xD;
  &#xD;
            3. Ability to provide informed consent&#xD;
  &#xD;
            4. Fluency in written and spoken English (to be able to complete assessments)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. any implants, conditions, etc. that do not comply with 7T (Tesla) fMRI research safety&#xD;
               standards (e.g., pacemaker, pregnancy/possible pregnancy)&#xD;
  &#xD;
            2. history of significant head injury/lengthy loss of consciousness (e.g., a Glasgow Coma&#xD;
               Scale Score &lt; 15 at the time of incident as assessed retrospectively by participant)&#xD;
  &#xD;
            3. significant untreated medical illness&#xD;
  &#xD;
            4. history of neurological or neurodevelopmental disorder&#xD;
  &#xD;
            5. history of any pervasive developmental disorder&#xD;
  &#xD;
            6. lifetime bipolar or psychotic disorder&#xD;
  &#xD;
            7. alcohol/substance abuse or dependence within the last 3 months&#xD;
  &#xD;
            8. extensive narcotic use (e.g., fentanyl, oxycodone, etc.)&#xD;
  &#xD;
            9. anyone who would not be suitable for short-term treatment (as determined by our&#xD;
               pre-treatment assessment)&#xD;
  &#xD;
           10. suicide attempt in last 6 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ruth Lanius, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Lawson Health Research/Western University/LHSC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Suzy - Coordinator</last_name>
      <phone>519-685-8500</phone>
      <phone_ext>35186</phone_ext>
      <email>suzy.southwell@lhsc.on.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>London Health Sciences Centre - University Hospital</name>
        <address>
          <city>London</city>
          <state>Ontario</state>
          <zip>N6A 5A5</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <reference>
      <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.</citation>
      <PMID>32318157</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>25854674</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>28911803</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>33178406</PMID>
    </reference>
    <reference>
      <citation>Warner, E., Westcott, A., Cook, A., &amp; Finn, H. (2020). Transforming trauma in children and adolescents: An embodied approach to somatic regulation, trauma processing, and attachment-building. North Atlantic Books.</citation>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
      <investigator_full_name>Ruth Lanius</investigator_full_name>
      <investigator_title>MD, PhD, Professor of Psychiatry, Harris-Woodman Chair, University of Western Ontario</investigator_title>
    </responsible_party>
    <keyword>PTSD</keyword>
    <keyword>Post-traumatic Stress Disorder</keyword>
    <keyword>Body-based trauma therapy</keyword>
    <keyword>Movement-based trauma therapy</keyword>
    <keyword>Sensory-motor</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stress Disorders, Traumatic</mesh_term>
      <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Only coded data will be shared with co-investigators who are registered with the study's ethics board application.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06035809
  org study id: ReDA: 12919
  secondary id: 121855
  nct id: NCT06035809
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  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.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Assessors will be blinded to which treatment arm a participant was assigned.
  measure: Change in Clinician Administered PTSD Scale (CAPS) score from pre-treatment to post-treatment assessment.
  time frame: 8 weeks
  description: Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms
  measure: Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment.
  time frame: 12 weeks
  description: Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms
  measure: Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from pre-treatment to post-treatment assessment.
  time frame: 8 weeks
  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.
  measure: Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from post-treatment to 3-month follow-up assessment.
  time frame: 12 weeks
  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.
  measure: Change in Sensory-Motor function as assessed by Sensory-Motor assessment from pre-treatment to post-treatment assessment.
  time frame: 8 weeks
  description: Practical assessment of tactile, vestibular and proprioceptive abilities.
  arm group label: Active SMART
  arm group type: Experimental
  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 group label: Wait List
  arm group type: No Intervention
  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: SMART
  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.
  arm group label: Active SMART
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Ruth Lanius, MD, PhD
  role: Principal Investigator
  affiliation: Lawson Health Research/Western University/LHSC
  last name: Suzy - Coordinator
  phone: 519-685-8500
  phone ext: 35186
  email: suzy.southwell@lhsc.on.ca
  facility: 
  country: Canada
  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.
  PMID: 32318157
  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.
  PMID: 25854674
  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.
  PMID: 28911803
  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.
  PMID: 33178406
  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.
  responsible party type: Principal Investigator
  investigator affiliation: Lawson Health Research Institute
  investigator full name: Ruth Lanius
  investigator title: MD, PhD, Professor of Psychiatry, Harris-Woodman Chair, University of Western Ontario
  mesh term: Stress Disorders, Traumatic
  mesh term: Stress Disorders, Post-Traumatic
  sharing ipd: No
  ipd description: Only coded data will be shared with co-investigators who are registered with the study's ethics board application.