<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/NCT04457271</url>
  </required_header>
  <id_info>
    <org_study_id>10037</org_study_id>
    <secondary_id>116096</secondary_id>
    <nct_id>NCT04457271</nct_id>
  </id_info>
  <brief_title>Goal Management Training in Individuals With PTSD</brief_title>
  <official_title>An EffectivenessTrial Examining a Novel Approach to Cognitive Remediation in Individuals With Post-Traumatic Stress Disorder (PTSD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>FDC Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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 evaluate the effect of a manualized treatment (Goal Management Training, or&#xD;
      GMT) on the cognitive impairments associated with PTSD (Post-Traumatic Stress Disorder), as&#xD;
      well as any impact on PTSD symptems themselves. Participants will be randomized to either GMT&#xD;
      group treatment, or a wait list condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PTSD has an emotional impact on individuals, but it is also associated with impaired&#xD;
      cognitive functioning (e.g., processing speed, attention, executive functioning). This study&#xD;
      is an effectiveness trial investigating a cognitive remediation intervention (Goal Management&#xD;
      Training, or GMT) that has been shown to improve the cognitive impairment observed in other&#xD;
      populations (e.g., older adults). The present study will investigate the impact of GMT in&#xD;
      adults experiencing PTSD (including frontline healthcare workers suffering from PTSD related&#xD;
      to the COVID-19 pandemic) and its associated cognitive impairment. Participants will be&#xD;
      randomly assigned to one of two treatment conditions - GMT, or a wait list condition (in&#xD;
      which GMT will be postponed for approximately 21 weeks). Due to the pandemic, this study will&#xD;
      be conducted primarily online (i.e., online assessments and treatment, with optional fMRI&#xD;
      scans - functional magnetic resonance imaging). Once all assessments are complete,&#xD;
      participants in the wait list condition will be able to begin GMT thelmselves.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unfortunately, we have had to prioritize other studies and we do not have the resources&#xD;
    required to carry out this study.&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2023</start_date>
  <completion_date type="Anticipated">February 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</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>Single Group Assignment</intervention_model>
    <intervention_model_description>This study is an effectiveness trial investigating GMT as an intervention for both PTSD-related cognitive impairment/dysfunction, and PTSD symptoms themselves. Participants will be randomized to one of two conditions: GMT or wait list.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Sustained Attention to Response Task (SART) scores from baseline to post-treatment assessment</measure>
    <time_frame>9 weeks</time_frame>
    <description>A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Sustained Attention to Response Task (SART) scores from post-treatment to 3-month follow-up assessment</measure>
    <time_frame>12 weeks</time_frame>
    <description>A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in score on Tower Test (part of Millisecond's online cognitive battery) from baseline to post-treatment assessment.</measure>
    <time_frame>9 weeks</time_frame>
    <description>Assesses the participant's ability to act with forethought, and sequence behaviour in an orderly fashion to reach specific goals (i.e., executive functioning). Similar to the Tower of London test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in score on Tower Test (part of Millisecond's online cognitive battery) from post-treatment to 3-month follow-up assessment.</measure>
    <time_frame>12 weeks</time_frame>
    <description>Assesses the participant's ability to act with forethought, and sequence behaviour in an orderly fashion to reach specific goals (i.e., executive functioning). Similar to the Tower of London test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Difficulties in Emotion Regulation Scale (DERS) score from baseline to post-treatment assessment</measure>
    <time_frame>9 weeks</time_frame>
    <description>A 36-item self-report measure that assesses difficulties with emotion regulation across six domains. A total score is derived by summing all the items - ranging from 36 to 180. Higher scores indicate greater dysfunction in emotion regulation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Difficulties in Emotion Regulation Scale (DERS) score from post-treatment to 3-month follow-up assessment</measure>
    <time_frame>12 weeks</time_frame>
    <description>A 36-item self-report measure that assesses difficulties with emotion regulation across six domains. A total score is derived by summing all the items - ranging from 36 to 180. Higher scores indicate greater dysfunction in emotion regulation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment assessment</measure>
    <time_frame>9 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>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>PTSD</condition>
  <condition>Post-traumatic Stress Disorder</condition>
  <condition>Cognitive Impairment</condition>
  <condition>Cognitive Dysfunction</condition>
  <condition>Cognitive Deficit</condition>
  <arm_group>
    <arm_group_label>Goal Management Training (GMT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will attend 9 weekly, 2-hour group GMT appointments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait List</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this arm will receive no treatment for approximately 21 weeks (at which point, they will be offered the same, standard GMT treatment).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Goal Management Training (GMT)</intervention_name>
    <description>GMT is a structured, short-term cognitive remediation program with an emphasis on mindfulness and practice in planning and completion of goal-oriented behaviours. The main objective of GMT is to help participants regain executive control in order to better define goals and monitor performance in achieving them. Sessions include instructional material, interactive tasks, discussion of patients' real-life deficits, and homework assignments. Mindfulness meditation is also incorporated for the purpose of developing the skill of bringing one's mind to the present to monitor ongoing behaviour, goal states, and the relationship between them, and for the development of attentional control. The program incorporates real-life examples to illustrate goal attainment failures and successes, as well as in-session practice of complex tasks that mimic real-life tasks - typically a challenge for individuals with executive function deficits (e.g., planning and set-shifting tasks).</description>
    <arm_group_label>Goal Management Training (GMT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of PTSD as determined by our baseline assessment&#xD;
&#xD;
          -  Due to online nature: must have access to (and ability to use) a computer/tablet with&#xD;
             a working microphone and camera (or webcam), reliable access to a secure internet&#xD;
             connection, and access to a quiet, private space for the assessments and group&#xD;
             sessions.&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  Fluency in written and spoken English&#xD;
&#xD;
          -  must be resident of Ontario (due to restrictions of professional licenses)&#xD;
&#xD;
        Exclusion Criteria for those opting in to fMRI scan:&#xD;
&#xD;
          -  any implants, conditions, etc. that do not comply with 7T (Tesla) fMRI research safety&#xD;
             standards (e.g., pacemaker, pregnancy/possible pregnancy)&#xD;
&#xD;
        Exclusion Criteria for study in general:&#xD;
&#xD;
          -  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;
          -  significant untreated medical illness&#xD;
&#xD;
          -  history of neurological or neurodevelopmental disorder&#xD;
&#xD;
          -  history of any pervasive developmental disorder&#xD;
&#xD;
          -  any medical disorder known to adversely affect cognition within the last 12 months&#xD;
&#xD;
          -  lifetime bipolar or psychotic disorder&#xD;
&#xD;
          -  alcohol/substance abuse or dependence within the last 3 months&#xD;
&#xD;
          -  extensive narcotic use (e.g., fentanyl, oxycodone, etc.), use of anti-cholinergics,&#xD;
             anti-psychotics, psychostimulants, or benzodiazepines&#xD;
&#xD;
          -  ECT (electroconvulsive therapy) within the last 12 months&#xD;
&#xD;
          -  significant dissociative disorder (as determined by our baseline assessment)&#xD;
&#xD;
          -  suicide attempt in last 6 months&#xD;
&#xD;
          -  pregnancy (due to impact of hormones on cognitive abilities)&#xD;
&#xD;
          -  hearing or vision issues that would interfere with effective online participation&#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 A. Lanius, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lawson Research Institute</affiliation>
  </overall_official>
  <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>
  <results_reference>
    <citation>Boyd JE, Lanius RA, McKinnon MC. Mindfulness-based treatments for posttraumatic stress disorder: a review of the treatment literature and neurobiological evidence. J Psychiatry Neurosci. 2018 Jan;43(1):7-25. doi: 10.1503/jpn.170021. Epub 2017 Oct 2.</citation>
    <PMID>29252162</PMID>
  </results_reference>
  <results_reference>
    <citation>Meusel LA, Hall GB, Fougere P, McKinnon MC, MacQueen GM. Neural correlates of cognitive remediation in patients with mood disorders. Psychiatry Res. 2013 Nov 30;214(2):142-52. doi: 10.1016/j.pscychresns.2013.06.007. Epub 2013 Aug 30.</citation>
    <PMID>23993991</PMID>
  </results_reference>
  <results_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>
  </results_reference>
  <results_reference>
    <citation>McKinnon MC, Boyd JE, Frewen PA, Lanius UF, Jetly R, Richardson JD, Lanius RA. A review of the relation between dissociation, memory, executive functioning and social cognition in military members and civilians with neuropsychiatric conditions. Neuropsychologia. 2016 Sep;90:210-34. doi: 10.1016/j.neuropsychologia.2016.07.017. Epub 2016 Jul 18.</citation>
    <PMID>27444881</PMID>
  </results_reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>February 3, 2023</last_update_submitted>
  <last_update_submitted_qc>February 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GMT</keyword>
  <keyword>Goal Management Training</keyword>
  <keyword>mindfulness</keyword>
  <keyword>Cognitive Remediation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    <mesh_term>Cognition Disorders</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>


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/NCT04457271
org study id: 10037
secondary id: 116096
nct id: NCT04457271
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the effect of a manualized treatment (Goal Management Training, or
      GMT) on the cognitive impairments associated with PTSD (Post-Traumatic Stress Disorder), as
      well as any impact on PTSD symptems themselves. Participants will be randomized to either GMT
      group treatment, or a wait list condition.
PTSD has an emotional impact on individuals, but it is also associated with impaired
      cognitive functioning (e.g., processing speed, attention, executive functioning). This study
      is an effectiveness trial investigating a cognitive remediation intervention (Goal Management
      Training, or GMT) that has been shown to improve the cognitive impairment observed in other
      populations (e.g., older adults). The present study will investigate the impact of GMT in
      adults experiencing PTSD (including frontline healthcare workers suffering from PTSD related
      to the COVID-19 pandemic) and its associated cognitive impairment. Participants will be
      randomly assigned to one of two treatment conditions - GMT, or a wait list condition (in
      which GMT will be postponed for approximately 21 weeks). Due to the pandemic, this study will
      be conducted primarily online (i.e., online assessments and treatment, with optional fMRI
      scans - functional magnetic resonance imaging). Once all assessments are complete,
      participants in the wait list condition will be able to begin GMT thelmselves.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: This study is an effectiveness trial investigating GMT as an intervention for both PTSD-related cognitive impairment/dysfunction, and PTSD symptoms themselves. Participants will be randomized to one of two conditions: GMT or wait list.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Sustained Attention to Response Task (SART) scores from baseline to post-treatment assessment
time frame: 9 weeks
description: A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance.
measure: Change in Sustained Attention to Response Task (SART) scores from post-treatment to 3-month follow-up assessment
time frame: 12 weeks
description: A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance.
measure: Change in score on Tower Test (part of Millisecond's online cognitive battery) from baseline to post-treatment assessment.
time frame: 9 weeks
description: Assesses the participant's ability to act with forethought, and sequence behaviour in an orderly fashion to reach specific goals (i.e., executive functioning). Similar to the Tower of London test.
measure: Change in score on Tower Test (part of Millisecond's online cognitive battery) from post-treatment to 3-month follow-up assessment.
time frame: 12 weeks
description: Assesses the participant's ability to act with forethought, and sequence behaviour in an orderly fashion to reach specific goals (i.e., executive functioning). Similar to the Tower of London test.
measure: Change in Difficulties in Emotion Regulation Scale (DERS) score from baseline to post-treatment assessment
time frame: 9 weeks
description: A 36-item self-report measure that assesses difficulties with emotion regulation across six domains. A total score is derived by summing all the items - ranging from 36 to 180. Higher scores indicate greater dysfunction in emotion regulation.
measure: Change in Difficulties in Emotion Regulation Scale (DERS) score from post-treatment to 3-month follow-up assessment
time frame: 12 weeks
description: A 36-item self-report measure that assesses difficulties with emotion regulation across six domains. A total score is derived by summing all the items - ranging from 36 to 180. Higher scores indicate greater dysfunction in emotion regulation.
measure: Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment assessment
time frame: 9 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
arm group label: Goal Management Training (GMT)
arm group type: Experimental
description: Participants in this arm will attend 9 weekly, 2-hour group GMT appointments.
arm group label: Wait List
arm group type: No Intervention
description: Participants in this arm will receive no treatment for approximately 21 weeks (at which point, they will be offered the same, standard GMT treatment).
intervention type: Behavioral
intervention name: Goal Management Training (GMT)
description: GMT is a structured, short-term cognitive remediation program with an emphasis on mindfulness and practice in planning and completion of goal-oriented behaviours. The main objective of GMT is to help participants regain executive control in order to better define goals and monitor performance in achieving them. Sessions include instructional material, interactive tasks, discussion of patients' real-life deficits, and homework assignments. Mindfulness meditation is also incorporated for the purpose of developing the skill of bringing one's mind to the present to monitor ongoing behaviour, goal states, and the relationship between them, and for the development of attentional control. The program incorporates real-life examples to illustrate goal attainment failures and successes, as well as in-session practice of complex tasks that mimic real-life tasks - typically a challenge for individuals with executive function deficits (e.g., planning and set-shifting tasks).
arm group label: Goal Management Training (GMT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ruth A. Lanius, MD, PhD
role: Principal Investigator
affiliation: Lawson Research Institute
facility: 
country: Canada
citation: Boyd JE, Lanius RA, McKinnon MC. Mindfulness-based treatments for posttraumatic stress disorder: a review of the treatment literature and neurobiological evidence. J Psychiatry Neurosci. 2018 Jan;43(1):7-25. doi: 10.1503/jpn.170021. Epub 2017 Oct 2.
PMID: 29252162
citation: Meusel LA, Hall GB, Fougere P, McKinnon MC, MacQueen GM. Neural correlates of cognitive remediation in patients with mood disorders. Psychiatry Res. 2013 Nov 30;214(2):142-52. doi: 10.1016/j.pscychresns.2013.06.007. Epub 2013 Aug 30.
PMID: 23993991
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: McKinnon MC, Boyd JE, Frewen PA, Lanius UF, Jetly R, Richardson JD, Lanius RA. A review of the relation between dissociation, memory, executive functioning and social cognition in military members and civilians with neuropsychiatric conditions. Neuropsychologia. 2016 Sep;90:210-34. doi: 10.1016/j.neuropsychologia.2016.07.017. Epub 2016 Jul 18.
PMID: 27444881
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
mesh term: Cognition Disorders
sharing ipd: No
ipd description: Only coded data will be shared with co-investigators who are registered with the study's ethics board application.