<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/NCT03825354</url>
  </required_header>
  <id_info>
    <org_study_id>Project Number: 5880</org_study_id>
    <nct_id>NCT03825354</nct_id>
  </id_info>
  <brief_title>Brief Intervention and Contact (BIC) Program</brief_title>
  <acronym>BIC</acronym>
  <official_title>Brief Intervention and Contact (BIC) Program to Manage Suicidal Behaviour: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Joseph's Healthcare Hamilton</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Joseph's Healthcare Hamilton</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>
      Suicide is a significant public health concern and causes approximately 1.5 % of all deaths&#xD;
      in the general population in Canada. Suicide is a multi-faceted issue that is often comorbid&#xD;
      with psychiatric illness and associated with diverse sociodemographic risk factors.&#xD;
      Consequently, there are several domains of suicide risk management. The proposed&#xD;
      intervention, the brief intervention, and contact (BIC) model will be tested for feasibility&#xD;
      using a pilot pragmatic randomized trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Brief contact interventions are distinct from other treatments for suicide and suicidal&#xD;
      behaviour, in that the goals include maintaining long-term contact with patients, and through&#xD;
      this, provide opportunities for them to re-engage with mental health services when needed.&#xD;
      Additionally, brief interventions are not required to be carried out by mental health&#xD;
      professionals (i.e. psychiatrists, psychologists, social workers), and they are provided over&#xD;
      a structured schedule over a prolonged period post discharge.&#xD;
&#xD;
      The brief intervention and contact (BIC) model followed in this study is based on the BIC&#xD;
      model that was utilised by the WHO as part of the Multisite Intervention Study On Suicidal&#xD;
      Behaviours (SUPRE-MISS). A sub-project of the SUPRE-MISS study involved the implementation of&#xD;
      a brief intervention that included an hour-long information session about suicide and&#xD;
      suicidal behaviour around the discharge period, and nine periods of follow up through an&#xD;
      in-person visit or phone call to assess the patient's well-being and provide referrals to&#xD;
      clinical services as needed. Following implementation, an analysis of the effectiveness of&#xD;
      the BIC model in five different countries, Brazil, India, Sri Lanka, Islamic Republic of&#xD;
      Iran, and China, outline its potential utility. Compared to patients in the control group,&#xD;
      there was a reduction in suicide rates in patients who received the BIC intervention.&#xD;
&#xD;
      This is a pilot study to test the feasibility of implementing the BIC protocol in a large&#xD;
      multisite trial. We will, however, provide the objective of the main study to provide an&#xD;
      overview of the study and the intended outcomes in addition to the pilot study objectives as&#xD;
      below.&#xD;
&#xD;
      Study question and hypothesis of the main study:&#xD;
&#xD;
      For patients with suicidal behaviour admitted to inpatient units of acute and tertiary&#xD;
      hospitals, does the addition of a brief intervention and contact program decrease suicide&#xD;
      re-attempts, reduce depressive symptoms, improve social connectivity, and reduce further ER&#xD;
      visits, compared to treatment as usual after 18 months of follow-up? The pilot study will be&#xD;
      for 6 months only. We hypothesize that brief intervention and contact is an effective&#xD;
      intervention for reducing suicidal behaviour in patients who have attempted suicide.&#xD;
&#xD;
      The intervention:&#xD;
&#xD;
      Patients in the intervention group will receive the BIC intervention, alongside treatment as&#xD;
      usual. BIC consists of a 1-hour information session about the epidemiology and presentation&#xD;
      of suicide and suicidal behaviour at the time of discharge, along with follow-up with&#xD;
      patients at 1, 2, 4, 6 weeks, and 3, 4, 5, and 6 months. The intention of the frequency of&#xD;
      follow up is to increase the time between follow up visits as per the original protocol and&#xD;
      eventually discontinue. Follow-up contact will involve assessing how patients feel and&#xD;
      whether they need additional support. The WHO protocol that contains all questionnaires to be&#xD;
      used for follow-up is attached to this protocol.&#xD;
&#xD;
      The control:&#xD;
&#xD;
      Patients in the control group will receive treatment as usual. Pilot Study Objectives&#xD;
&#xD;
      Primary objectives:&#xD;
&#xD;
      The main goal of pilot phase is to enhance the success of the full trial by testing the&#xD;
      feasibility of conducting a randomized controlled trial to assess the effectiveness of a&#xD;
      brief intervention and contact program for suicide delivered through a face to face, phone or&#xD;
      text-based intervention in addition to treatment as usual to reduce suicide attempts,&#xD;
      depressive symptoms and ER visits, and improve social connectivity.&#xD;
&#xD;
      The pilot primary objectives are therefore summarized after Thabane and colleagues (cite the&#xD;
      ref here):&#xD;
&#xD;
        1. Assess the feasibility of the study process in terms of recruitment, retention, number&#xD;
           of follow-ups completed, and data completion&#xD;
&#xD;
        2. Assess resources needed including the use of mobile phones for contacting patients,&#xD;
           interview spaces for initial intake questionnaire and consent processes.&#xD;
&#xD;
      Pilot study secondary objectives&#xD;
&#xD;
        1. Assess reduction in subsequent suicide attempts and completed suicides through access to&#xD;
           medical records over 6 months post discharge&#xD;
&#xD;
        2. Assess the change in depressive symptoms using the Beck Depression Inventory between and&#xD;
           within the intervention and control groups&#xD;
&#xD;
        3. Explore the change in sense of social connectivity and social support using the&#xD;
           Bille-Brahe Social Support Questionnaire, the Sarason Social Support Questionnaire&#xD;
           (short form), and two questions pertaining to the places and activities the patient&#xD;
           engages in most often between and within the intervention and control groups&#xD;
&#xD;
        4. Assess the reduction in ER visits between and within the intervention and control groups&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</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>a randomized study with 1:1 parallel design</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>6 months</time_frame>
    <description>The percentage of potential participants agree to consent to the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention rate</measure>
    <time_frame>6 months</time_frame>
    <description>The percentage of participants who completes the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Data completion rate</measure>
    <time_frame>6 months</time_frame>
    <description>the percentage of participants who complete all study questionnaires and follow up contacts</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of suicidal behaviour events</measure>
    <time_frame>6 months</time_frame>
    <description>The number of documented suicidal behaviour events including ideas, attempts and completion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Suicidal Behavior</condition>
  <arm_group>
    <arm_group_label>Brief Intervention and contact (BIC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Brief education about suicidal behaviour and follow up contacts for 6 months in addition to treatment as usual. follow up will occur at the following time points post discharge: weeks 1, 2, 4, 6, 8, 12, 16 and 20. this will occur in addition to treatment as usual.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control will continue treatment as usual which is whatever the clinical team decides upon post discharge. data will be collected on repeated suicidal behaviour through medical records with consent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>BIC</intervention_name>
    <description>World Health Organization, WHO, Brief Intervention and Contact (BIC)</description>
    <arm_group_label>Brief Intervention and contact (BIC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with a previous suicide attempt or expressed any suicidal behaviour who&#xD;
             are admitted to inpatient psychiatric wards will be asked to participate in this&#xD;
             study, with no upper age limit, sex or gender restriction.&#xD;
&#xD;
          -  No restrictions will be placed on the patients' diagnoses or comorbidities, although&#xD;
             all diagnoses will be documented.&#xD;
&#xD;
          -  Patients in inpatient units and receiving treatment for comorbid psychiatric illnesses&#xD;
             and/or their suicidal behaviour as per usual care including medication, individual or&#xD;
             group psychotherapies and other treatment modalities are eligible to participate in&#xD;
             the study.&#xD;
&#xD;
          -  All participants must be able to provide written informed consent and can be reached&#xD;
             through phone calls and/or text messages or in-person visits to the hospital site.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  We will exclude patients who are unable to understand written and spoken English, as&#xD;
             the research staff/clinicians delivering the intervention are limited to&#xD;
             English-speaking populations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>z Samaan, MD/PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Joseph's Healthcare Hamilton</name>
      <address>
        <city>Hamilton, Ontario</city>
        <state>Ontario</state>
        <zip>L8N 3K7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 31, 2022</last_update_submitted>
  <last_update_submitted_qc>January 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Joseph's Healthcare Hamilton</investigator_affiliation>
    <investigator_full_name>Zainab Samaan (Zena)</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>suicide</keyword>
  <keyword>thoughts</keyword>
  <keyword>attempts</keyword>
  <keyword>death</keyword>
  <keyword>brief intervention</keyword>
  <keyword>contact</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03825354
org study id: Project Number: 5880
nct id: NCT03825354
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Suicide is a significant public health concern and causes approximately 1.5 % of all deaths
      in the general population in Canada. Suicide is a multi-faceted issue that is often comorbid
      with psychiatric illness and associated with diverse sociodemographic risk factors.
      Consequently, there are several domains of suicide risk management. The proposed
      intervention, the brief intervention, and contact (BIC) model will be tested for feasibility
      using a pilot pragmatic randomized trial.
Brief contact interventions are distinct from other treatments for suicide and suicidal
      behaviour, in that the goals include maintaining long-term contact with patients, and through
      this, provide opportunities for them to re-engage with mental health services when needed.
      Additionally, brief interventions are not required to be carried out by mental health
      professionals (i.e. psychiatrists, psychologists, social workers), and they are provided over
      a structured schedule over a prolonged period post discharge.

      The brief intervention and contact (BIC) model followed in this study is based on the BIC
      model that was utilised by the WHO as part of the Multisite Intervention Study On Suicidal
      Behaviours (SUPRE-MISS). A sub-project of the SUPRE-MISS study involved the implementation of
      a brief intervention that included an hour-long information session about suicide and
      suicidal behaviour around the discharge period, and nine periods of follow up through an
      in-person visit or phone call to assess the patient's well-being and provide referrals to
      clinical services as needed. Following implementation, an analysis of the effectiveness of
      the BIC model in five different countries, Brazil, India, Sri Lanka, Islamic Republic of
      Iran, and China, outline its potential utility. Compared to patients in the control group,
      there was a reduction in suicide rates in patients who received the BIC intervention.

      This is a pilot study to test the feasibility of implementing the BIC protocol in a large
      multisite trial. We will, however, provide the objective of the main study to provide an
      overview of the study and the intended outcomes in addition to the pilot study objectives as
      below.

      Study question and hypothesis of the main study:

      For patients with suicidal behaviour admitted to inpatient units of acute and tertiary
      hospitals, does the addition of a brief intervention and contact program decrease suicide
      re-attempts, reduce depressive symptoms, improve social connectivity, and reduce further ER
      visits, compared to treatment as usual after 18 months of follow-up? The pilot study will be
      for 6 months only. We hypothesize that brief intervention and contact is an effective
      intervention for reducing suicidal behaviour in patients who have attempted suicide.

      The intervention:

      Patients in the intervention group will receive the BIC intervention, alongside treatment as
      usual. BIC consists of a 1-hour information session about the epidemiology and presentation
      of suicide and suicidal behaviour at the time of discharge, along with follow-up with
      patients at 1, 2, 4, 6 weeks, and 3, 4, 5, and 6 months. The intention of the frequency of
      follow up is to increase the time between follow up visits as per the original protocol and
      eventually discontinue. Follow-up contact will involve assessing how patients feel and
      whether they need additional support. The WHO protocol that contains all questionnaires to be
      used for follow-up is attached to this protocol.

      The control:

      Patients in the control group will receive treatment as usual. Pilot Study Objectives

      Primary objectives:

      The main goal of pilot phase is to enhance the success of the full trial by testing the
      feasibility of conducting a randomized controlled trial to assess the effectiveness of a
      brief intervention and contact program for suicide delivered through a face to face, phone or
      text-based intervention in addition to treatment as usual to reduce suicide attempts,
      depressive symptoms and ER visits, and improve social connectivity.

      The pilot primary objectives are therefore summarized after Thabane and colleagues (cite the
      ref here):

        1. Assess the feasibility of the study process in terms of recruitment, retention, number
           of follow-ups completed, and data completion

        2. Assess resources needed including the use of mobile phones for contacting patients,
           interview spaces for initial intake questionnaire and consent processes.

      Pilot study secondary objectives

        1. Assess reduction in subsequent suicide attempts and completed suicides through access to
           medical records over 6 months post discharge

        2. Assess the change in depressive symptoms using the Beck Depression Inventory between and
           within the intervention and control groups

        3. Explore the change in sense of social connectivity and social support using the
           Bille-Brahe Social Support Questionnaire, the Sarason Social Support Questionnaire
           (short form), and two questions pertaining to the places and activities the patient
           engages in most often between and within the intervention and control groups

        4. Assess the reduction in ER visits between and within the intervention and control groups
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: a randomized study with 1:1 parallel design
primary purpose: Other
masking: None (Open Label)
measure: Recruitment rate
time frame: 6 months
description: The percentage of potential participants agree to consent to the study
measure: Retention rate
time frame: 6 months
description: The percentage of participants who completes the study
measure: Data completion rate
time frame: 6 months
description: the percentage of participants who complete all study questionnaires and follow up contacts
measure: The number of suicidal behaviour events
time frame: 6 months
description: The number of documented suicidal behaviour events including ideas, attempts and completion
arm group label: Brief Intervention and contact (BIC)
arm group type: Experimental
description: Brief education about suicidal behaviour and follow up contacts for 6 months in addition to treatment as usual. follow up will occur at the following time points post discharge: weeks 1, 2, 4, 6, 8, 12, 16 and 20. this will occur in addition to treatment as usual.
arm group label: control
arm group type: No Intervention
description: control will continue treatment as usual which is whatever the clinical team decides upon post discharge. data will be collected on repeated suicidal behaviour through medical records with consent.
intervention type: Behavioral
intervention name: BIC
description: World Health Organization, WHO, Brief Intervention and Contact (BIC)
arm group label: Brief Intervention and contact (BIC)
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: z Samaan, MD/PhD
role: Principal Investigator
affiliation: McMaster University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: St. Joseph's Healthcare Hamilton
investigator full name: Zainab Samaan (Zena)
investigator title: Associate Professor
sharing ipd: No