<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/NCT03781297</url>
  </required_header>
  <id_info>
    <org_study_id>2017042</org_study_id>
    <nct_id>NCT03781297</nct_id>
  </id_info>
  <brief_title>Narrative Exposure Therapy Study for PTSD Among the Homeless Population</brief_title>
  <official_title>Protocol for a Feasibility Study of Narrative Exposure Therapy in Homeless Individuals With Post-Traumatic Stress Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Ottawa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Ottawa</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>
      The purpose of this study is to assess the acceptability and feasibility of delivering&#xD;
      Narrative Exposure Therapy to homeless individuals with Post-Traumatic Stress Disorder.&#xD;
&#xD;
      In Ottawa, in 2015, there were 6,825 people using 500,191 bed nights in the city emergency&#xD;
      shelters (Alliance to End Homelessness in Ottawa 2015 Annual Report) with approximately&#xD;
      another 500 sleeping on the streets (The Homelessness Community Capacity Building Steering&#xD;
      Committee 2008 Ottawa, ON). Mental health disorders, including substance abuse, are common in&#xD;
      this population, are often under treated and can be a source of considerable distress and&#xD;
      disability.&#xD;
&#xD;
      In addition to the high rates of mental disorder, there are three other significant factors&#xD;
      which impact morbidity. First, a history of significant childhood trauma is common which&#xD;
      impacts relationships and ability to cope with difficulties. It is increasingly recognized&#xD;
      that a trauma informed approach to providing services to the homeless population is needed.&#xD;
      There have been no randomized controlled trials of treatment of post-traumatic stress&#xD;
      disorder in the homeless population. Second, brain dysfunction from head injuries and&#xD;
      attention deficit disorder appear to be common. Problems with brain dysfunction can cause&#xD;
      difficulties especially with attention, impulsivity and managing relationships. Finally, life&#xD;
      for the marginally housed can be chaotic with day-to-day uncertainty over accommodation,&#xD;
      income and security. This means that providing health services to this population requires a&#xD;
      degree of flexibility in terms of who provides services, where and when.&#xD;
&#xD;
      These issues result in a population with complex needs that traditional mental health care is&#xD;
      poorly equipped to serve. At present there is a clear gap in the provision of services that&#xD;
      address the experience of trauma in homeless individuals. There are no services for trauma in&#xD;
      publicly funded hospitals, which leaves private providers as the sole source of treatment.&#xD;
      Other potential barriers include accounting for the effects of substance abuse, brain injury&#xD;
      and &quot;chaos&quot; in this population. What the investigators are proposing is a pilot study to&#xD;
      assess the feasibility and acceptability of providing a time-limited assessment and therapy&#xD;
      (six sessions) within the shelter system to homeless individuals diagnosed with&#xD;
      post-traumatic stress disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to assess the acceptability and feasibility of delivering&#xD;
      Narrative Exposure Therapy to homeless individuals with Post-Traumatic Stress Disorder. This&#xD;
      includes assessing the feasibility of recruiting sufficient numbers of participants,&#xD;
      conducting a randomized trial in the shelter system and achieving adequate participant&#xD;
      follow-up rates.&#xD;
&#xD;
      Study procedures will take place at shelters served by the Royal Ottawa Mental Health&#xD;
      Centre's Psychiatric Outreach Team and Inner City Health, which are: The Shepherds of Good&#xD;
      Hope, The Salvation Army, The Mission, Cornerstone Housing for Women, and other locations&#xD;
      served by The Royal Ottawa's Psychiatric Outreach Team and Inner City Health.&#xD;
&#xD;
      Homeless individuals who meet criteria for PTSD will be offered, in addition to usual care,&#xD;
      six sessions of Narrative Exposure Therapy either with or without the option of receiving&#xD;
      services from a genealogist to supplement the process of exploring their life narrative. A&#xD;
      total of 24 participants will be recruited into this study and will be randomized in a 1:1&#xD;
      allocation. At the start of their involvement in the study, participants randomized to&#xD;
      receive genealogical services will be provided with the option to access services from a&#xD;
      professional genealogist, to trace their family history. Participants will be made aware of&#xD;
      the fact that new family information will be revealed through this process, and also be&#xD;
      informed of the standard methods that will be used to extract this information which could&#xD;
      involve research through publicly available historical records or voluntary DNA testing.&#xD;
&#xD;
      The primary outcomes for this study are acceptability - the investigators would deem the&#xD;
      interventions acceptable if 50% of people approached consented to be randomized; and&#xD;
      feasibility - the investigators would deem the study feasible if the planned sample size was&#xD;
      recruited over a period of six months. Secondary outcomes include changes from baseline on&#xD;
      relevant rating scales of symptoms, housing status, quality of life; and follow-up of&#xD;
      participants three months from enrollment. This study will inform mental health treatment of&#xD;
      this chronically underserved population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">June 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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability measured by Recruitment Rates</measure>
    <time_frame>6 months</time_frame>
    <description>The investigators would deem the interventions acceptable if 50% of people approached consented to participate in the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility measured by Sample Size</measure>
    <time_frame>6 months</time_frame>
    <description>The investigators would deem a larger study to be feasible if the investigators could identify the planned sample size (n=24) over a six month period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability &amp; Feasibility of Collecting Outcome Data measured by Retention Rates</measure>
    <time_frame>6 months</time_frame>
    <description>Collecting outcome data within this population will be determined acceptable/feasible if dropout and incomplete outcome assessment is limited to 25% of participants three months after the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Post-Traumatic Stress Disorder (PTSD) symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5)</measure>
    <time_frame>Baseline, Week 8, Week 12</time_frame>
    <description>The PTSD Checklist for DSM-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. The PCL-5 will be collected as part of the Narrative Exposure Therapy Session to quantify PTSD symptoms and traumatic experiences. Blevins et al. (2015) demonstrated that PCL-5 scores exhibited strong internal consistency (α = .94), test-retest reliability (r = .82), and convergent (rs = .74 to .85) and discriminant (rs = .31 to .60) validity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Housing Status as measured by Self-Report from Participants</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 12</time_frame>
    <description>Any changes in housing status during the study period (including follow-up period) will be noted. This will be assessed by asking the participants directly about their current housing status throughout the study period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in scores on Health-Related Quality of Life and Functioning as measured by the 20-item Medical Outcomes Survey Short Form Health Survey (SF-20)</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 12</time_frame>
    <description>This is a 20-item questionnaire that assesses various health outcomes, and the extent to which health related problems interfere with daily life. The SF-20 [27] uses questions related to 8 domains: physical functioning, role functioning (physical), bodily pain, general health, vitality, social functioning, role functioning (emotional) and mental health. Each item is scored on a scale of 0 to 100 and then averaged to obtain a sub-scale score. Sub-scale scores on the SF-20 are rated on a scale from 0 to 100, with high scores indicating a higher degree of functionality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores for Substance Use/Misuse as measured by the Addiction Severity Index (ASI)</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 12</time_frame>
    <description>A semi-structured interview used to assess severity of substance abuse problems. Questions are related to the following seven potential areas that could be impacted by substance use: Medical, Employment/Support Status, Legal, Family/Social and Psychiatric, as well as Alcohol specific and Drug specific questions. This interview gathers information on current (past 30 days) and lifetime substance abuse.&#xD;
Severity ratings are based on the following 10 point scale (0-9): 0-1 No real problem, treatment not indicated; 2-3 Slight problem, treatment probably not necessary; 4-5 Moderate problem, some treatment indicated; 6-7 Considerable problem, treatment necessary; 8-9 Extreme problem, treatment absolutely necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores for Alcohol Use/Misuse as measured by the Alcohol Use Disorder Identification Test (AUDIT)</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 12</time_frame>
    <description>The AUDIT questionnaire is designed to assess the following four dimensions of alcohol misuse: Alcohol consumption (3 items); Drinking behaviour (3 items); Adverse reactions (2 items); Alcohol-related problems (2 items).&#xD;
The first three items of the AUDIT (AUDIT-C) will be used as a screening questionnaire. Participants who score above 4 on the first three items of the AUDIT-C will be asked to complete the Full AUDIT. In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.&#xD;
For the Full AUDIT, a score of (0-7) indicates low-risk. (8-15) indicates risky or a hazardous level of drinking behaviours. (16-19) indicates high-risk or a harmful level of drinking behaviours. A score of (20 or more) indicates high risk alcohol related behaviours and an almost certainty of dependence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Health Care Costs as measured by Self-Report Questionnaire</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 12</time_frame>
    <description>A questionnaire has been created by the research team to capture data related to health care costs. The Health Care Costs questionnaire is an 11-item questionnaire that evaluates the effect of mental health on an individual's ability to work and perform regular activities.&#xD;
Specifically, elements from the Client Service Receipt Inventory (CSRI) and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI: SHP) as well as other health cost indicators used in previous studies conducted by the Principal Investigator.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Severity of Attention Deficit Hyperactivity Disorder (ADHD) as measured by the ADHD Self-Report Scale (ASRS)</measure>
    <time_frame>Baseline</time_frame>
    <description>The ASRS an 18-item self-report questionnaire that assesses the inattentive (6 items) and hyperactive/impulsive (12 items) dimensions of ADHD. Participants are asked to rate items of a five-point Likert scale from &quot;Never&quot; (0) to &quot;Very Often&quot; (4), with total scores on each sub-scale ranging from 0-24 (inattentive) and 0-48 (hyperactive/impulsive). Scores between (0-16) indicate an unlikely presentation of ADHD. Scores between (17-23) indicate a likely presentation of ADHD. Scores of (24) or greater indicate a highly likely presentation of ADHD.</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of Cognitive Functioning as measured by the Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>Baseline</time_frame>
    <description>Cognitive functioning will be assessed using the Montreal Cognitive Assessment (MoCA), which can be administered in ten minutes and includes the assessment of the following cognitive skills: alternating trail making; visuocontructional skills (cube); visuocontructional skills (clock); naming; memory; attention; sentence repetition; verbal fluency; abstraction; delayed recall; and, orientation [33]. Total possible scores for the MoCA range from 0 to 30, with a score of 26 or above being considered normative. This measure will be used in the initial assessment only for the purposes of tailoring the intervention for the individual.</description>
  </other_outcome>
  <other_outcome>
    <measure>Diagnosis of PTSD as measured by the MINI International Neurpsychiatric Interview</measure>
    <time_frame>Baseline</time_frame>
    <description>A clinical interview with a delegated study staff member will be conducted with each participant enrolled in the study. This interview will be guided by the Mini International Neurpsychiatric Interview (MINI) to confirm a diagnosis of PTSD.</description>
  </other_outcome>
  <other_outcome>
    <measure>Demographic Characteristics as measured by Self-Report</measure>
    <time_frame>Baseline</time_frame>
    <description>Includes assessments of gender identity, age, marital status, ethnicity, primary language, level of education, Canadian Armed Forces membership and sexual identity</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>PTSD</condition>
  <arm_group>
    <arm_group_label>Intervention: NET+G</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In addition to usual care, participants will receive six sessions of Narrative Exposure Therapy over six weeks plus the option to receive genealogical services.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention: NET</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In addition to usual care, participants will receive six sessions of Narrative Exposure Therapy over six weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Narrative Exposure Therapy</intervention_name>
    <description>Narrative Exposure Therapy attempts to place the trauma within a narrative of the person's life. Anecdotal evidence of using this approach in the homeless population is that constructing an autobiography helps to give meaning to their problems and provide the initial steps in constructing a core sense of belonging and identity. Six sessions of individual therapy allows for participants to work with a therapist one-on-one to position their experiences of trauma within their life story.</description>
    <arm_group_label>Intervention: NET</arm_group_label>
    <arm_group_label>Intervention: NET+G</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Genealogical Services</intervention_name>
    <description>At the start of their involvement in the, study participants randomized to this group will be provided with the option to access services from a professional genealogist, to trace their family history. Participants will be made aware of the fact that new family information will be revealed through this process, and also be informed of the standard methods that will be used to extract this information which could involve research through publicly available historical records or voluntary DNA testing.</description>
    <arm_group_label>Intervention: NET+G</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients must:&#xD;
&#xD;
          -  Be 18 years of age or older;&#xD;
&#xD;
          -  Be referred to the study by the Psychiatric Outreach program at the Royal Ottawa&#xD;
             Health Care Group or by Inner City Health;&#xD;
&#xD;
          -  Meet DSM-5 criteria for post-traumatic stress disorder, as measured by the Mini&#xD;
             International Neuropsychiatric Interview (MINI); and,&#xD;
&#xD;
          -  Be homeless or vulnerably housed at the time of their screening visit, as measured by&#xD;
             the Housing Status Questionnaire.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients must not:&#xD;
&#xD;
          -  Be unable to speak and understand English;&#xD;
&#xD;
          -  Be unwilling to attend Narrative Therapy session for a period of six weeks;&#xD;
&#xD;
          -  Be unwilling to return to a designated therapy location to complete study follow-up&#xD;
             appointments;&#xD;
&#xD;
          -  Be unwilling or unable to provide informed consent;&#xD;
&#xD;
          -  Present to their study screening visit acutely intoxicated;&#xD;
&#xD;
          -  Be, in the opinion of the Investigator, unlikely to commit to a 12-week study; or&#xD;
&#xD;
          -  Pose a risk of harm to study staff or other clients.&#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>Simon Hatcher, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ottawa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Ottawa</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1N 6N5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
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    <citation>Zanis DA, McLellan AT, Cnaan RA, Randall M. Reliability and validity of the Addiction Severity Index with a homeless sample. J Subst Abuse Treat. 1994 Nov-Dec;11(6):541-8. doi: 10.1016/0740-5472(94)90005-1.</citation>
    <PMID>7884837</PMID>
  </reference>
  <reference>
    <citation>Carey KB, Carey MP, Chandra PS. Psychometric evaluation of the alcohol use disorders identification test and short drug abuse screening test with psychiatric patients in India. J Clin Psychiatry. 2003 Jul;64(7):767-74. doi: 10.4088/jcp.v64n0705.</citation>
    <PMID>12934976</PMID>
  </reference>
  <reference>
    <citation>Bohn MJ, Babor TF, Kranzler HR. The Alcohol Use Disorders Identification Test (AUDIT): validation of a screening instrument for use in medical settings. J Stud Alcohol. 1995 Jul;56(4):423-32. doi: 10.15288/jsa.1995.56.423.</citation>
    <PMID>7674678</PMID>
  </reference>
  <reference>
    <citation>Adler LA, Spencer T, Faraone SV, Kessler RC, Howes MJ, Biederman J, Secnik K. Validity of pilot Adult ADHD Self- Report Scale (ASRS) to Rate Adult ADHD symptoms. Ann Clin Psychiatry. 2006 Jul-Sep;18(3):145-8. doi: 10.1080/10401230600801077.</citation>
    <PMID>16923651</PMID>
  </reference>
  <reference>
    <citation>Rossetti HC, Lacritz LH, Cullum CM, Weiner MF. Normative data for the Montreal Cognitive Assessment (MoCA) in a population-based sample. Neurology. 2011 Sep 27;77(13):1272-5. doi: 10.1212/WNL.0b013e318230208a. Epub 2011 Sep 14.</citation>
    <PMID>21917776</PMID>
  </reference>
  <reference>
    <citation>Cocks K, Torgerson DJ. Sample size calculations for pilot randomized trials: a confidence interval approach. J Clin Epidemiol. 2013 Feb;66(2):197-201. doi: 10.1016/j.jclinepi.2012.09.002. Epub 2012 Nov 27.</citation>
    <PMID>23195919</PMID>
  </reference>
  <reference>
    <citation>Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics 2005; 4: 287-91.</citation>
  </reference>
  <reference>
    <citation>Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.</citation>
    <PMID>9881538</PMID>
  </reference>
  <reference>
    <citation>Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013 Sep;22(7):1717-27. doi: 10.1007/s11136-012-0322-4. Epub 2012 Nov 25.</citation>
    <PMID>23184421</PMID>
  </reference>
  <reference>
    <citation>Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.</citation>
    <PMID>26606250</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>October 21, 2021</last_update_submitted>
  <last_update_submitted_qc>October 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Ottawa</investigator_affiliation>
    <investigator_full_name>Dr. Simon Hatcher</investigator_full_name>
    <investigator_title>Scientist</investigator_title>
  </responsible_party>
  <keyword>Homeless Populations</keyword>
  <keyword>PTSD</keyword>
  <keyword>Narrative Exposure Therapy</keyword>
  <keyword>Individual Therapy</keyword>
  <keyword>Genealogy</keyword>
  <pending_results>
    <submitted>May 31, 2022</submitted>
    <returned>March 6, 2023</returned>
    <submitted>September 8, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03781297
org study id: 2017042
nct id: NCT03781297
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the acceptability and feasibility of delivering
      Narrative Exposure Therapy to homeless individuals with Post-Traumatic Stress Disorder.

      In Ottawa, in 2015, there were 6,825 people using 500,191 bed nights in the city emergency
      shelters (Alliance to End Homelessness in Ottawa 2015 Annual Report) with approximately
      another 500 sleeping on the streets (The Homelessness Community Capacity Building Steering
      Committee 2008 Ottawa, ON). Mental health disorders, including substance abuse, are common in
      this population, are often under treated and can be a source of considerable distress and
      disability.

      In addition to the high rates of mental disorder, there are three other significant factors
      which impact morbidity. First, a history of significant childhood trauma is common which
      impacts relationships and ability to cope with difficulties. It is increasingly recognized
      that a trauma informed approach to providing services to the homeless population is needed.
      There have been no randomized controlled trials of treatment of post-traumatic stress
      disorder in the homeless population. Second, brain dysfunction from head injuries and
      attention deficit disorder appear to be common. Problems with brain dysfunction can cause
      difficulties especially with attention, impulsivity and managing relationships. Finally, life
      for the marginally housed can be chaotic with day-to-day uncertainty over accommodation,
      income and security. This means that providing health services to this population requires a
      degree of flexibility in terms of who provides services, where and when.

      These issues result in a population with complex needs that traditional mental health care is
      poorly equipped to serve. At present there is a clear gap in the provision of services that
      address the experience of trauma in homeless individuals. There are no services for trauma in
      publicly funded hospitals, which leaves private providers as the sole source of treatment.
      Other potential barriers include accounting for the effects of substance abuse, brain injury
      and "chaos" in this population. What the investigators are proposing is a pilot study to
      assess the feasibility and acceptability of providing a time-limited assessment and therapy
      (six sessions) within the shelter system to homeless individuals diagnosed with
      post-traumatic stress disorder.
The purpose of this study is to assess the acceptability and feasibility of delivering
      Narrative Exposure Therapy to homeless individuals with Post-Traumatic Stress Disorder. This
      includes assessing the feasibility of recruiting sufficient numbers of participants,
      conducting a randomized trial in the shelter system and achieving adequate participant
      follow-up rates.

      Study procedures will take place at shelters served by the Royal Ottawa Mental Health
      Centre's Psychiatric Outreach Team and Inner City Health, which are: The Shepherds of Good
      Hope, The Salvation Army, The Mission, Cornerstone Housing for Women, and other locations
      served by The Royal Ottawa's Psychiatric Outreach Team and Inner City Health.

      Homeless individuals who meet criteria for PTSD will be offered, in addition to usual care,
      six sessions of Narrative Exposure Therapy either with or without the option of receiving
      services from a genealogist to supplement the process of exploring their life narrative. A
      total of 24 participants will be recruited into this study and will be randomized in a 1:1
      allocation. At the start of their involvement in the study, participants randomized to
      receive genealogical services will be provided with the option to access services from a
      professional genealogist, to trace their family history. Participants will be made aware of
      the fact that new family information will be revealed through this process, and also be
      informed of the standard methods that will be used to extract this information which could
      involve research through publicly available historical records or voluntary DNA testing.

      The primary outcomes for this study are acceptability - the investigators would deem the
      interventions acceptable if 50% of people approached consented to be randomized; and
      feasibility - the investigators would deem the study feasible if the planned sample size was
      recruited over a period of six months. Secondary outcomes include changes from baseline on
      relevant rating scales of symptoms, housing status, quality of life; and follow-up of
      participants three months from enrollment. This study will inform mental health treatment of
      this chronically underserved population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Acceptability measured by Recruitment Rates
time frame: 6 months
description: The investigators would deem the interventions acceptable if 50% of people approached consented to participate in the study.
measure: Feasibility measured by Sample Size
time frame: 6 months
description: The investigators would deem a larger study to be feasible if the investigators could identify the planned sample size (n=24) over a six month period.
measure: Acceptability & Feasibility of Collecting Outcome Data measured by Retention Rates
time frame: 6 months
description: Collecting outcome data within this population will be determined acceptable/feasible if dropout and incomplete outcome assessment is limited to 25% of participants three months after the intervention.
measure: Change in Post-Traumatic Stress Disorder (PTSD) symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5)
time frame: Baseline, Week 8, Week 12
description: The PTSD Checklist for DSM-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. The PCL-5 will be collected as part of the Narrative Exposure Therapy Session to quantify PTSD symptoms and traumatic experiences. Blevins et al. (2015) demonstrated that PCL-5 scores exhibited strong internal consistency (α = .94), test-retest reliability (r = .82), and convergent (rs = .74 to .85) and discriminant (rs = .31 to .60) validity.
measure: Change in Housing Status as measured by Self-Report from Participants
time frame: Baseline, Week 4, Week 8, Week 12
description: Any changes in housing status during the study period (including follow-up period) will be noted. This will be assessed by asking the participants directly about their current housing status throughout the study period.
measure: Change in scores on Health-Related Quality of Life and Functioning as measured by the 20-item Medical Outcomes Survey Short Form Health Survey (SF-20)
time frame: Baseline, Week 4, Week 8, Week 12
description: This is a 20-item questionnaire that assesses various health outcomes, and the extent to which health related problems interfere with daily life. The SF-20 [27] uses questions related to 8 domains: physical functioning, role functioning (physical), bodily pain, general health, vitality, social functioning, role functioning (emotional) and mental health. Each item is scored on a scale of 0 to 100 and then averaged to obtain a sub-scale score. Sub-scale scores on the SF-20 are rated on a scale from 0 to 100, with high scores indicating a higher degree of functionality.
measure: Change in Scores for Substance Use/Misuse as measured by the Addiction Severity Index (ASI)
time frame: Baseline, Week 4, Week 8, Week 12
description: A semi-structured interview used to assess severity of substance abuse problems. Questions are related to the following seven potential areas that could be impacted by substance use: Medical, Employment/Support Status, Legal, Family/Social and Psychiatric, as well as Alcohol specific and Drug specific questions. This interview gathers information on current (past 30 days) and lifetime substance abuse.
Severity ratings are based on the following 10 point scale (0-9): 0-1 No real problem, treatment not indicated; 2-3 Slight problem, treatment probably not necessary; 4-5 Moderate problem, some treatment indicated; 6-7 Considerable problem, treatment necessary; 8-9 Extreme problem, treatment absolutely necessary.
measure: Change in Scores for Alcohol Use/Misuse as measured by the Alcohol Use Disorder Identification Test (AUDIT)
time frame: Baseline, Week 4, Week 8, Week 12
description: The AUDIT questionnaire is designed to assess the following four dimensions of alcohol misuse: Alcohol consumption (3 items); Drinking behaviour (3 items); Adverse reactions (2 items); Alcohol-related problems (2 items).
The first three items of the AUDIT (AUDIT-C) will be used as a screening questionnaire. Participants who score above 4 on the first three items of the AUDIT-C will be asked to complete the Full AUDIT. In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.
For the Full AUDIT, a score of (0-7) indicates low-risk. (8-15) indicates risky or a hazardous level of drinking behaviours. (16-19) indicates high-risk or a harmful level of drinking behaviours. A score of (20 or more) indicates high risk alcohol related behaviours and an almost certainty of dependence.
measure: Change in Health Care Costs as measured by Self-Report Questionnaire
time frame: Baseline, Week 4, Week 8, Week 12
description: A questionnaire has been created by the research team to capture data related to health care costs. The Health Care Costs questionnaire is an 11-item questionnaire that evaluates the effect of mental health on an individual's ability to work and perform regular activities.
Specifically, elements from the Client Service Receipt Inventory (CSRI) and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI: SHP) as well as other health cost indicators used in previous studies conducted by the Principal Investigator.
measure: Severity of Attention Deficit Hyperactivity Disorder (ADHD) as measured by the ADHD Self-Report Scale (ASRS)
time frame: Baseline
description: The ASRS an 18-item self-report questionnaire that assesses the inattentive (6 items) and hyperactive/impulsive (12 items) dimensions of ADHD. Participants are asked to rate items of a five-point Likert scale from "Never" (0) to "Very Often" (4), with total scores on each sub-scale ranging from 0-24 (inattentive) and 0-48 (hyperactive/impulsive). Scores between (0-16) indicate an unlikely presentation of ADHD. Scores between (17-23) indicate a likely presentation of ADHD. Scores of (24) or greater indicate a highly likely presentation of ADHD.
measure: Level of Cognitive Functioning as measured by the Montreal Cognitive Assessment (MoCA)
time frame: Baseline
description: Cognitive functioning will be assessed using the Montreal Cognitive Assessment (MoCA), which can be administered in ten minutes and includes the assessment of the following cognitive skills: alternating trail making; visuocontructional skills (cube); visuocontructional skills (clock); naming; memory; attention; sentence repetition; verbal fluency; abstraction; delayed recall; and, orientation [33]. Total possible scores for the MoCA range from 0 to 30, with a score of 26 or above being considered normative. This measure will be used in the initial assessment only for the purposes of tailoring the intervention for the individual.
measure: Diagnosis of PTSD as measured by the MINI International Neurpsychiatric Interview
time frame: Baseline
description: A clinical interview with a delegated study staff member will be conducted with each participant enrolled in the study. This interview will be guided by the Mini International Neurpsychiatric Interview (MINI) to confirm a diagnosis of PTSD.
measure: Demographic Characteristics as measured by Self-Report
time frame: Baseline
description: Includes assessments of gender identity, age, marital status, ethnicity, primary language, level of education, Canadian Armed Forces membership and sexual identity
arm group label: Intervention: NET+G
arm group type: Active Comparator
description: In addition to usual care, participants will receive six sessions of Narrative Exposure Therapy over six weeks plus the option to receive genealogical services.
arm group label: Intervention: NET
arm group type: Active Comparator
description: In addition to usual care, participants will receive six sessions of Narrative Exposure Therapy over six weeks.
intervention type: Other
intervention name: Narrative Exposure Therapy
description: Narrative Exposure Therapy attempts to place the trauma within a narrative of the person's life. Anecdotal evidence of using this approach in the homeless population is that constructing an autobiography helps to give meaning to their problems and provide the initial steps in constructing a core sense of belonging and identity. Six sessions of individual therapy allows for participants to work with a therapist one-on-one to position their experiences of trauma within their life story.
arm group label: Intervention: NET
arm group label: Intervention: NET+G
intervention type: Other
intervention name: Genealogical Services
description: At the start of their involvement in the, study participants randomized to this group will be provided with the option to access services from a professional genealogist, to trace their family history. Participants will be made aware of the fact that new family information will be revealed through this process, and also be informed of the standard methods that will be used to extract this information which could involve research through publicly available historical records or voluntary DNA testing.
arm group label: Intervention: NET+G
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Simon Hatcher, MD
role: Principal Investigator
affiliation: University of Ottawa
facility: 
country: Canada
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PMID: 7884837
citation: Carey KB, Carey MP, Chandra PS. Psychometric evaluation of the alcohol use disorders identification test and short drug abuse screening test with psychiatric patients in India. J Clin Psychiatry. 2003 Jul;64(7):767-74. doi: 10.4088/jcp.v64n0705.
PMID: 12934976
citation: Bohn MJ, Babor TF, Kranzler HR. The Alcohol Use Disorders Identification Test (AUDIT): validation of a screening instrument for use in medical settings. J Stud Alcohol. 1995 Jul;56(4):423-32. doi: 10.15288/jsa.1995.56.423.
PMID: 7674678
citation: Adler LA, Spencer T, Faraone SV, Kessler RC, Howes MJ, Biederman J, Secnik K. Validity of pilot Adult ADHD Self- Report Scale (ASRS) to Rate Adult ADHD symptoms. Ann Clin Psychiatry. 2006 Jul-Sep;18(3):145-8. doi: 10.1080/10401230600801077.
PMID: 16923651
citation: Rossetti HC, Lacritz LH, Cullum CM, Weiner MF. Normative data for the Montreal Cognitive Assessment (MoCA) in a population-based sample. Neurology. 2011 Sep 27;77(13):1272-5. doi: 10.1212/WNL.0b013e318230208a. Epub 2011 Sep 14.
PMID: 21917776
citation: Cocks K, Torgerson DJ. Sample size calculations for pilot randomized trials: a confidence interval approach. J Clin Epidemiol. 2013 Feb;66(2):197-201. doi: 10.1016/j.jclinepi.2012.09.002. Epub 2012 Nov 27.
PMID: 23195919
citation: Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics 2005; 4: 287-91.
citation: Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
PMID: 9881538
citation: Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013 Sep;22(7):1717-27. doi: 10.1007/s11136-012-0322-4. Epub 2012 Nov 25.
PMID: 23184421
citation: Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
PMID: 26606250
responsible party type: Principal Investigator
investigator affiliation: University of Ottawa
investigator full name: Dr. Simon Hatcher
investigator title: Scientist
submitted: May 31, 2022
returned: March 6, 2023
submitted: September 8, 2023