<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/NCT04495543</url>
  </required_header>
  <id_info>
    <org_study_id>BSL-01</org_study_id>
    <nct_id>NCT04495543</nct_id>
  </id_info>
  <brief_title>Mitigating Suicide Risk With Single Session 'Brief Skills for Safer Living'</brief_title>
  <official_title>Mitigating Suicide Risk During the COVID-19 Pandemic Via Telehealth Using an Intensive Single Session of &quot;Brief Skills for Safer Living&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</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>
      Mental health concerns have been on the rise since the onset of the COVID-19 pandemic. The&#xD;
      pandemic has worsened risk factors for suicide, including job loss, anxiety, depression, and&#xD;
      loneliness. Timely and easy access to mental health services is a dire need, and this study&#xD;
      will test the efficacy and feasibility of a brief clinical intervention, Brief Skills for&#xD;
      Safer Living (Brief-SfSL), at reducing suicide risk. The goal of this study is to investigate&#xD;
      whether Brief-SfSL, delivered online, is a suitable, acceptable and effective method for&#xD;
      reducing suicide risk and providing timely mental health services. The results from this&#xD;
      study will provide vital insight into effective interventions for suicide risk that are&#xD;
      accessible and can be widely distributed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will test a brief online clinical intervention targeting suicide risk that will be&#xD;
      delivered widely, remotely, rapidly and with minimal load on the healthcare system in Canada.&#xD;
      The &quot;Skills for Safer Living&quot; (SfSL) intervention, a transdiagnostic 20-week group therapy&#xD;
      intervention designed to teach concepts, skills and coping strategies through modules&#xD;
      targeting common areas of deficits (Personal Safety, Emotional Literacy, Interpersonal&#xD;
      Relationships and Problem-Solving), will be adapted into a single session &quot;Brief-SfSL&quot; that&#xD;
      can be delivered in an online format. The proposed study will test the effectiveness of&#xD;
      Brief-SfSL on reducing suicide risk, as measured by reductions in suicidal ideation after 3&#xD;
      months, and will provide evidence for a scalable intervention that can broadly reach urban&#xD;
      and rural communities. Lack of suicide intervention services is an immense unmet need that is&#xD;
      especially pronounced during this pandemic and is associated with increased burden on&#xD;
      individuals and on the healthcare system. Considering the long wait times to access&#xD;
      consistent psychiatric services, this proposed intervention is an essential step in providing&#xD;
      evidence-based accessible suicide risk services during and even beyond the pandemic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">February 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>3 month, within subjects longitudinal study, with each participant receiving an intensive, single session of the 'Brief Skills for Safer Living' intervention designed to mitigate suicide risk. All participants recruited will have experienced suicidal ideation within the past week at time of enrolment.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in suicidal ideation using Beck Scale for Suicide Ideation</measure>
    <time_frame>From baseline to 3 months; also administered at screening, 1 week and 1 month</time_frame>
    <description>Beck Scale for Suicide Ideation is a 21-item self-report scale that quantifies suicidal ideation. Items are scored 0 to 2 and yield a total score ranging from 0 to 38. Higher scores reflect greater severity of suicidal ideation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in depression symptoms using the Quick Inventory of Depressive Symptoms self-report scale (QIDS-SR)</measure>
    <time_frame>From baseline to 3 months; also administered at 1 week and 1 month</time_frame>
    <description>The QIDS-SR is a 16-item validated self-report depression scale. Total scores range from 0 (none) to 27 (very severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7)</measure>
    <time_frame>From baseline to 3 months; also administered at 1 week and 1 month</time_frame>
    <description>The GAD-7 is a brief 7-item self-report scale measuring anxiety symptoms. Total scores range from 0 to 21, with higher scores reflecting more severe anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Acquired Capability of Suicide Scale (ACSS)</measure>
    <time_frame>From baseline to 3 months; also administered at 1 week and 1 month</time_frame>
    <description>The ACSS is a 20-item self-report instrument to assess the construct of acquired capability. Total scores range from 0 to 80, with higher scores reflecting greater acquired capability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Interpersonal Needs Questionnaire score</measure>
    <time_frame>From baseline to 3 months; also administered at 1 week and 1 month</time_frame>
    <description>The Interpersonal Needs Questionnaire is a 15-item self-report scale assessing connectedness to others and burdensomeness. Items are rated 1 to 7, with total scores ranging from 15 to 105. Higher scores reflect worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dimensional Anhedonia Rating Scale (DARS) score</measure>
    <time_frame>From baseline to 3 months; also administered at 1 week and 1 month</time_frame>
    <description>The DARS is a 26-item self-report scale measuring anhedonia across four domains. Items are scored on a 5-point Likert scale with lower total scores reflecting more severe anhedonia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sheehan Disability Scale (SDS) score</measure>
    <time_frame>From baseline to 3 months; also administered at 1 month</time_frame>
    <description>The SDS is a brief 3-item self-report scale that probes work/school, social, and family/home functioning. Each item is scored from 0 to 10. Total scores range from 0 (unimpaired) to 30 (highly impaired).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Treatment Utilization</measure>
    <time_frame>From screening to 3 months; also administered at 1 month</time_frame>
    <description>Use of healthcare services will be assessed through four questions enquiring about the frequency and description of health care professional visits, use of mental health services, hospital admissions, and emergency room visits in the preceding specified time frame (1-3 months).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Participant feedback on their experiences with specific aspects of the Brief-SfSL intervention</measure>
    <time_frame>3 months</time_frame>
    <description>Feasibility and Acceptability survey and interview created in-house with questions designed to collect quantitative and qualitative feedback from participants with respect to the feasibility and acceptability of the Brief-SfSL intervention.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Suicidal Ideation</condition>
  <condition>Suicide</condition>
  <condition>Mental Health Issue</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Brief-Skills for Safer Living (Brief-SfSL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with current suicidal ideation (Beck Suicide Scale &gt;10) will undergo Brief-SfSLtherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Skills for Safer Living</intervention_name>
    <description>Brief-SfSL is a single-session individual therapy adaptation of the core goals/principles of the 20-week SfSL group therapy. Brief-SfSL incorporates the SfSL guiding principles of emphasizing safety, attending to the therapeutic relationship, recognizing the participant as the expert in their own experience, taking a trauma-informed approach, working with emotions while recognizing the role of alexithymia, and incorporating solution-focused concepts. The goal is to increase a person's understanding and capacity to engage in what would enable them to keep safe, even if thoughts of suicide are present. The intervention procedure is dynamic, but includes 4 core tasks: 1) understanding the individual's suicidal experience, 2) skills building, 3) developing a safety plan, and 4) identifying obstacles to enacting or engaging with the safety plan.</description>
    <arm_group_label>Brief-Skills for Safer Living (Brief-SfSL)</arm_group_label>
    <other_name>Brief-SfSL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Experiencing suicidal ideation in the past week (Beck Suicide Scale&gt;10)&#xD;
&#xD;
          -  Ability to undergo psychotherapy in English&#xD;
&#xD;
          -  Access to a computer with a camera or a mobile phone with a camera&#xD;
&#xD;
          -  Access to internet&#xD;
&#xD;
          -  Access to an emergency contact and hospital within commuting distance&#xD;
&#xD;
          -  Not receiving other psychotherapy concurrently&#xD;
&#xD;
          -  Willing to have the session recorded to review therapy fidelity&#xD;
&#xD;
          -  Follow-up visits with a psychiatrist or family doctor where a psychotherapeutic&#xD;
             modality (e.g. DBT, psychodynamic therapy, etc.) is not being used are allowable.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The presence of cognitive impairment that would limit consent or understanding of&#xD;
             Brief-SfSL&#xD;
&#xD;
          -  The presence of active psychosis&#xD;
&#xD;
          -  Current substance use disorder&#xD;
&#xD;
          -  Unwilling or unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sakina Rizvi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sakina Rizvi, PhD</last_name>
    <phone>416-864-6060</phone>
    <phone_ext>6489</phone_ext>
    <email>sakina.rizvi@unityhealth.to</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael Morton, HBSc</last_name>
    <phone>416-864-6060</phone>
    <phone_ext>47844</phone_ext>
    <email>michael.morton@unityhealth.to</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1M8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Morton, HBSc</last_name>
      <phone>416-864-6060</phone>
      <phone_ext>47844</phone_ext>
      <email>michael.morton@unityhealth.to</email>
    </contact>
    <investigator>
      <last_name>Sakina Rizvi, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sidney H Kennedy, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yvonne Bergmans, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aleksandra Lalovic, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Unity Health Toronto</investigator_affiliation>
    <investigator_full_name>Sakina Rizvi</investigator_full_name>
    <investigator_title>Scientist</investigator_title>
  </responsible_party>
  <keyword>Suicide</keyword>
  <keyword>Suicide Prevention</keyword>
  <keyword>Suicide Risk</keyword>
  <keyword>Suicidal Ideation</keyword>
  <keyword>Psychotherapy</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Suicidal Ideation</mesh_term>
  </condition_browse>
  <!-- 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/NCT04495543
org study id: BSL-01
nct id: NCT04495543
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Mental health concerns have been on the rise since the onset of the COVID-19 pandemic. The
      pandemic has worsened risk factors for suicide, including job loss, anxiety, depression, and
      loneliness. Timely and easy access to mental health services is a dire need, and this study
      will test the efficacy and feasibility of a brief clinical intervention, Brief Skills for
      Safer Living (Brief-SfSL), at reducing suicide risk. The goal of this study is to investigate
      whether Brief-SfSL, delivered online, is a suitable, acceptable and effective method for
      reducing suicide risk and providing timely mental health services. The results from this
      study will provide vital insight into effective interventions for suicide risk that are
      accessible and can be widely distributed.
This study will test a brief online clinical intervention targeting suicide risk that will be
      delivered widely, remotely, rapidly and with minimal load on the healthcare system in Canada.
      The "Skills for Safer Living" (SfSL) intervention, a transdiagnostic 20-week group therapy
      intervention designed to teach concepts, skills and coping strategies through modules
      targeting common areas of deficits (Personal Safety, Emotional Literacy, Interpersonal
      Relationships and Problem-Solving), will be adapted into a single session "Brief-SfSL" that
      can be delivered in an online format. The proposed study will test the effectiveness of
      Brief-SfSL on reducing suicide risk, as measured by reductions in suicidal ideation after 3
      months, and will provide evidence for a scalable intervention that can broadly reach urban
      and rural communities. Lack of suicide intervention services is an immense unmet need that is
      especially pronounced during this pandemic and is associated with increased burden on
      individuals and on the healthcare system. Considering the long wait times to access
      consistent psychiatric services, this proposed intervention is an essential step in providing
      evidence-based accessible suicide risk services during and even beyond the pandemic.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: 3 month, within subjects longitudinal study, with each participant receiving an intensive, single session of the 'Brief Skills for Safer Living' intervention designed to mitigate suicide risk. All participants recruited will have experienced suicidal ideation within the past week at time of enrolment.
primary purpose: Prevention
masking: None (Open Label)
measure: Change in suicidal ideation using Beck Scale for Suicide Ideation
time frame: From baseline to 3 months; also administered at screening, 1 week and 1 month
description: Beck Scale for Suicide Ideation is a 21-item self-report scale that quantifies suicidal ideation. Items are scored 0 to 2 and yield a total score ranging from 0 to 38. Higher scores reflect greater severity of suicidal ideation.
measure: Change in depression symptoms using the Quick Inventory of Depressive Symptoms self-report scale (QIDS-SR)
time frame: From baseline to 3 months; also administered at 1 week and 1 month
description: The QIDS-SR is a 16-item validated self-report depression scale. Total scores range from 0 (none) to 27 (very severe).
measure: Change in anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7)
time frame: From baseline to 3 months; also administered at 1 week and 1 month
description: The GAD-7 is a brief 7-item self-report scale measuring anxiety symptoms. Total scores range from 0 to 21, with higher scores reflecting more severe anxiety.
measure: Change in Acquired Capability of Suicide Scale (ACSS)
time frame: From baseline to 3 months; also administered at 1 week and 1 month
description: The ACSS is a 20-item self-report instrument to assess the construct of acquired capability. Total scores range from 0 to 80, with higher scores reflecting greater acquired capability.
measure: Change in Interpersonal Needs Questionnaire score
time frame: From baseline to 3 months; also administered at 1 week and 1 month
description: The Interpersonal Needs Questionnaire is a 15-item self-report scale assessing connectedness to others and burdensomeness. Items are rated 1 to 7, with total scores ranging from 15 to 105. Higher scores reflect worse outcomes.
measure: Change in Dimensional Anhedonia Rating Scale (DARS) score
time frame: From baseline to 3 months; also administered at 1 week and 1 month
description: The DARS is a 26-item self-report scale measuring anhedonia across four domains. Items are scored on a 5-point Likert scale with lower total scores reflecting more severe anhedonia.
measure: Change in Sheehan Disability Scale (SDS) score
time frame: From baseline to 3 months; also administered at 1 month
description: The SDS is a brief 3-item self-report scale that probes work/school, social, and family/home functioning. Each item is scored from 0 to 10. Total scores range from 0 (unimpaired) to 30 (highly impaired).
measure: Change in Treatment Utilization
time frame: From screening to 3 months; also administered at 1 month
description: Use of healthcare services will be assessed through four questions enquiring about the frequency and description of health care professional visits, use of mental health services, hospital admissions, and emergency room visits in the preceding specified time frame (1-3 months).
measure: Participant feedback on their experiences with specific aspects of the Brief-SfSL intervention
time frame: 3 months
description: Feasibility and Acceptability survey and interview created in-house with questions designed to collect quantitative and qualitative feedback from participants with respect to the feasibility and acceptability of the Brief-SfSL intervention.
arm group label: Brief-Skills for Safer Living (Brief-SfSL)
arm group type: Experimental
description: Participants with current suicidal ideation (Beck Suicide Scale >10) will undergo Brief-SfSLtherapy
intervention type: Behavioral
intervention name: Brief Skills for Safer Living
description: Brief-SfSL is a single-session individual therapy adaptation of the core goals/principles of the 20-week SfSL group therapy. Brief-SfSL incorporates the SfSL guiding principles of emphasizing safety, attending to the therapeutic relationship, recognizing the participant as the expert in their own experience, taking a trauma-informed approach, working with emotions while recognizing the role of alexithymia, and incorporating solution-focused concepts. The goal is to increase a person's understanding and capacity to engage in what would enable them to keep safe, even if thoughts of suicide are present. The intervention procedure is dynamic, but includes 4 core tasks: 1) understanding the individual's suicidal experience, 2) skills building, 3) developing a safety plan, and 4) identifying obstacles to enacting or engaging with the safety plan.
arm group label: Brief-Skills for Safer Living (Brief-SfSL)
other name: Brief-SfSL
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sakina Rizvi, PhD
role: Principal Investigator
affiliation: Unity Health Toronto
last name: Sakina Rizvi, PhD
phone: 416-864-6060
phone ext: 6489
email: sakina.rizvi@unityhealth.to
last name: Michael Morton, HBSc
phone: 416-864-6060
phone ext: 47844
email: michael.morton@unityhealth.to
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Unity Health Toronto
investigator full name: Sakina Rizvi
investigator title: Scientist
mesh term: Depression
mesh term: Suicide
mesh term: Suicidal Ideation