PTSDNCT03781297
Narrative Exposure Therapy Study for PTSD Among the Homeless Population
A study testing Narrative Exposure Therapy and Genealogical Services in people with PTSD, run by University of Ottawa at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- Narrative Exposure Therapy and Genealogical Services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 11 Feb 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must:
- Be 18 years of age or older;
- Be referred to the study by the Psychiatric Outreach program at the Royal Ottawa Health Care Group or by Inner City Health;
- Meet DSM-5 criteria for post-traumatic stress disorder, as measured by the Mini International Neuropsychiatric Interview (MINI); and,
- Be homeless or vulnerably housed at the time of their screening visit, as measured by the Housing Status Questionnaire.
Who cannot join
- Patients must not:
- Be unable to speak and understand English;
- Be unwilling to attend Narrative Therapy session for a period of six weeks;
- Be unwilling to return to a designated therapy location to complete study follow-up appointments;
- Be unwilling or unable to provide informed consent;
- Present to their study screening visit acutely intoxicated;
- Be, in the opinion of the Investigator, unlikely to commit to a 12-week study; or
- Pose a risk of harm to study staff or other clients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol for a Feasibility Study of Narrative Exposure Therapy in Homeless Individuals 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.
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.
Read more
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.
Read the detailed description
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.
- Conditions
- PTSD
- Being tested
- Narrative Exposure Therapy, Genealogical Services
- Keywords
- Homeless Populations, PTSD, Narrative Exposure Therapy, Individual Therapy, Genealogy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Exposure TherapyOther
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.
Genealogical ServicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: NET+G | Active comparator | In addition to usual care, participants will receive six sessions of Narrative Exposure Therapy over six weeks plus the option to receive genealogical services. Receives: Other: Narrative Exposure Therapy; Other: Genealogical Services |
| Intervention: NET | Active comparator | In addition to usual care, participants will receive six sessions of Narrative Exposure Therapy over six weeks. Receives: Other: Narrative Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability measured by Recruitment Rates
The investigators would deem the interventions acceptable if 50% of people approached consented to participate in the study.
Measured: 6 months
Feasibility measured by Sample Size
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.
Measured: 6 months
Secondary outcomes (7)
Acceptability & Feasibility of Collecting Outcome Data measured by Retention Rates
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.
Measured: 6 months
Change in Post-Traumatic Stress Disorder (PTSD) symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5)
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.
Measured: Baseline, Week 8, Week 12
Change in Housing Status as measured by Self-Report from Participants
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.
Measured: Baseline, Week 4, Week 8, Week 12
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)
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.
Measured: Baseline, Week 4, Week 8, Week 12
Change in Scores for Substance Use/Misuse as measured by the Addiction Severity Index (ASI)
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.
Measured: Baseline, Week 4, Week 8, Week 12
Change in Scores for Alcohol Use/Misuse as measured by the Alcohol Use Disorder Identification Test (AUDIT)
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.
Measured: Baseline, Week 4, Week 8, Week 12
Change in Health Care Costs as measured by Self-Report Questionnaire
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.
Measured: Baseline, Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start11 Feb 2019
- Primary completion30 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Hospital Research Institute
- Responsible party
- Principal investigator, Dr. Simon Hatcher, University of Ottawa
- Investigators
- Simon Hatcher, MD, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781297
- Sponsor's protocol ID
- 2017042
- Status last verified
- Oct 2021
- First submitted
- 20 Jun 2018
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fazel S, Khosla V, Doll H, Geddes J. The prevalence of mental disorders among the homeless in western countries: systematic review and meta-regression analysis. PLoS Med. 2008 Dec 2;5(12):e225. doi: 10.1371/journal.pmed.0050225.
PubMed 19053169Fazel S, Geddes JR, Kushel M. The health of homeless people in high-income countries: descriptive epidemiology, health consequences, and clinical and policy recommendations. Lancet. 2014 Oct 25;384(9953):1529-40. doi: 10.1016/S0140-6736(14)61132-6.
PubMed 25390578Torchalla I, Strehlau V, Li K, Aube Linden I, Noel F, Krausz M. Posttraumatic stress disorder and substance use disorder comorbidity in homeless adults: Prevalence, correlates, and sex differences. Psychol Addict Behav. 2014 Jun;28(2):443-52. doi: 10.1037/a0033674. Epub 2013 Aug 5.
PubMed 23915373Kumar SA, Brand BL, Courtois CA. The need for trauma training: Clinicians' reactions to training on complex trauma. Psychol Trauma. 2022 Nov;14(8):1387-1394. doi: 10.1037/tra0000515. Epub 2019 Oct 3.
PubMed 31580137Litz BT, Stein N, Delaney E, Lebowitz L, Nash WP, Silva C, Maguen S. Moral injury and moral repair in war veterans: a preliminary model and intervention strategy. Clin Psychol Rev. 2009 Dec;29(8):695-706. doi: 10.1016/j.cpr.2009.07.003. Epub 2009 Jul 29.
PubMed 19683376Dinnen S, Kane V, Cook JM. Trauma-informed care: a paradigm shift needed for services with homeless veterans. Prof Case Manag. 2014 Jul-Aug;19(4):161-70; quiz 171-2. doi: 10.1097/NCM.0000000000000038.
PubMed 24871433Hopper E, Bassuk E, Olivet J. Shelter from the storm: Trauma-informed care in homelessness service settings. The Open Health Services and Policy Journal 2010; 3: 80-100.
Topolovec-Vranic J, Ennis N, Colantonio A, Cusimano MD, Hwang SW, Kontos P, Ouchterlony D, Stergiopoulos V. Traumatic brain injury among people who are homeless: a systematic review. BMC Public Health. 2012 Dec 8;12:1059. doi: 10.1186/1471-2458-12-1059.
PubMed 23216886To MJ, O'Brien K, Palepu A, Hubley AM, Farrell S, Aubry T, Gogosis E, Muckle W, Hwang SW. Healthcare Utilization, Legal Incidents, and Victimization Following Traumatic Brain Injury in Homeless and Vulnerably Housed Individuals: A Prospective Cohort Study. J Head Trauma Rehabil. 2015 Jul-Aug;30(4):270-6. doi: 10.1097/HTR.0000000000000044.
PubMed 24651000Salavera C, Antonanzas JL, Bustamante JC, Carron J, Usan P, Teruel P, Bericat C, Monteagudo L, Larrosa S, Tricas JM, Lucha O, Noe R, Jarie L, Cerra R. Comorbidity of attention deficit hyperactivity disorder with personality disorders in homeless people. BMC Res Notes. 2014 Dec 16;7:916. doi: 10.1186/1756-0500-7-916.
PubMed 25516377Farrell SJ, Huff J, MacDonald SA, Middlebro A, Walsh S. Taking it to the street: a psychiatric outreach service in Canada. Community Ment Health J. 2005 Dec;41(6):737-46. doi: 10.1007/s10597-005-6430-7.
PubMed 16328586Schauer M, Neuner F, Elbert T. Narrative Exposure Therapy: A short term treatment for traumatic stress disorders. 2nd ed. Cambridge, MA: Hogrefe Publishing; 2011.
Cloitre M. Effective psychotherapies for posttraumatic stress disorder: a review and critique. CNS Spectr. 2009 Jan;14(1 Suppl 1):32-43.
PubMed 19169192Morkved N, Hartmann K, Aarsheim LM, Holen D, Milde AM, Bomyea J, Thorp SR. A comparison of Narrative Exposure Therapy and Prolonged Exposure therapy for PTSD. Clin Psychol Rev. 2014 Aug;34(6):453-67. doi: 10.1016/j.cpr.2014.06.005. Epub 2014 Jun 26.
PubMed 25047447van Minnen A, Arntz A, Keijsers GP. Prolonged exposure in patients with chronic PTSD: predictors of treatment outcome and dropout. Behav Res Ther. 2002 Apr;40(4):439-57. doi: 10.1016/s0005-7967(01)00024-9.
PubMed 12002900
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Feasibility Study of Narrative Exposure Therapy in Homeless Individuals With Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT03781297
- Acronym / sponsor ID
- 2017042
- Conditions
- PTSD
- Keywords
- Homeless Populations, PTSD, Narrative Exposure Therapy, Individual Therapy, Genealogy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- Ottawa Hospital Research Institute
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: NET+G | Active comparator | Other: Narrative Exposure Therapy, Other: Genealogical ServicesIn addition to usual care, participants will receive six sessions of Narrative Exposure Therapy over six weeks plus the option to receive genealogical services. |
| Intervention: NET | Active comparator | Other: Narrative Exposure TherapyIn addition to usual care, participants will receive six sessions of Narrative Exposure Therapy over six weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be 18 years of age or older;
- Be referred to the study by the Psychiatric Outreach program at the Royal Ottawa Health Care Group or by Inner City Health;
- Meet DSM-5 criteria for post-traumatic stress disorder, as measured by the Mini International Neuropsychiatric Interview (MINI); and,
- Be homeless or vulnerably housed at the time of their screening visit, as measured by the Housing Status Questionnaire.
Key exclusion criteria (8 listed)
- Be unable to speak and understand English;
- Be unwilling to attend Narrative Therapy session for a period of six weeks;
- Be unwilling to return to a designated therapy location to complete study follow-up appointments;
- Be unwilling or unable to provide informed consent;
- Present to their study screening visit acutely intoxicated;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative Exposure TherapyNarrative 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. | Other | Intervention: NET, Intervention: NET+G |
| Genealogical ServicesAt 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. | Other | Intervention: NET+G |
Primary outcome
Acceptability measured by Recruitment Rates
Time frame: 6 months
The investigators would deem the interventions acceptable if 50% of people approached consented to participate in the study.
Feasibility measured by Sample Size
Time frame: 6 months
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.
7 secondary outcomes
Acceptability & Feasibility of Collecting Outcome Data measured by Retention Rates
Time frame: 6 months
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
Change in Housing Status as measured by Self-Report from Participants
Time frame: Baseline, Week 4, Week 8, Week 12
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
Change in Scores for Substance Use/Misuse as measured by the Addiction Severity Index (ASI)
Time frame: Baseline, Week 4, Week 8, Week 12
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
Change in Health Care Costs as measured by Self-Report Questionnaire
Time frame: Baseline, Week 4, Week 8, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Background: PubMed 19053169Fazel S, Khosla V, Doll H, Geddes J. The prevalence of mental disorders among the homeless in western countries: systematic review and meta-regression analysis. PLoS Med. 2008 Dec 2;5(12):e225. doi: 10.1371/journal.pmed.0050225.
- Background: PubMed 25390578Fazel S, Geddes JR, Kushel M. The health of homeless people in high-income countries: descriptive epidemiology, health consequences, and clinical and policy recommendations. Lancet. 2014 Oct 25;384(9953):1529-40. doi: 10.1016/S0140-6736(14)61132-6.
- Background: PubMed 23915373Torchalla I, Strehlau V, Li K, Aube Linden I, Noel F, Krausz M. Posttraumatic stress disorder and substance use disorder comorbidity in homeless adults: Prevalence, correlates, and sex differences. Psychol Addict Behav. 2014 Jun;28(2):443-52. doi: 10.1037/a0033674. Epub 2013 Aug 5.
- Background: PubMed 31580137Kumar SA, Brand BL, Courtois CA. The need for trauma training: Clinicians' reactions to training on complex trauma. Psychol Trauma. 2022 Nov;14(8):1387-1394. doi: 10.1037/tra0000515. Epub 2019 Oct 3.
- Background: PubMed 19683376Litz BT, Stein N, Delaney E, Lebowitz L, Nash WP, Silva C, Maguen S. Moral injury and moral repair in war veterans: a preliminary model and intervention strategy. Clin Psychol Rev. 2009 Dec;29(8):695-706. doi: 10.1016/j.cpr.2009.07.003. Epub 2009 Jul 29.
- Background: PubMed 24871433Dinnen S, Kane V, Cook JM. Trauma-informed care: a paradigm shift needed for services with homeless veterans. Prof Case Manag. 2014 Jul-Aug;19(4):161-70; quiz 171-2. doi: 10.1097/NCM.0000000000000038.
- BackgroundHopper E, Bassuk E, Olivet J. Shelter from the storm: Trauma-informed care in homelessness service settings. The Open Health Services and Policy Journal 2010; 3: 80-100.
- Background: PubMed 23216886Topolovec-Vranic J, Ennis N, Colantonio A, Cusimano MD, Hwang SW, Kontos P, Ouchterlony D, Stergiopoulos V. Traumatic brain injury among people who are homeless: a systematic review. BMC Public Health. 2012 Dec 8;12:1059. doi: 10.1186/1471-2458-12-1059.
- Background: PubMed 24651000To MJ, O'Brien K, Palepu A, Hubley AM, Farrell S, Aubry T, Gogosis E, Muckle W, Hwang SW. Healthcare Utilization, Legal Incidents, and Victimization Following Traumatic Brain Injury in Homeless and Vulnerably Housed Individuals: A Prospective Cohort Study. J Head Trauma Rehabil. 2015 Jul-Aug;30(4):270-6. doi: 10.1097/HTR.0000000000000044.
- Background: PubMed 25516377Salavera C, Antonanzas JL, Bustamante JC, Carron J, Usan P, Teruel P, Bericat C, Monteagudo L, Larrosa S, Tricas JM, Lucha O, Noe R, Jarie L, Cerra R. Comorbidity of attention deficit hyperactivity disorder with personality disorders in homeless people. BMC Res Notes. 2014 Dec 16;7:916. doi: 10.1186/1756-0500-7-916.
- Background: PubMed 16328586Farrell SJ, Huff J, MacDonald SA, Middlebro A, Walsh S. Taking it to the street: a psychiatric outreach service in Canada. Community Ment Health J. 2005 Dec;41(6):737-46. doi: 10.1007/s10597-005-6430-7.
- BackgroundSchauer M, Neuner F, Elbert T. Narrative Exposure Therapy: A short term treatment for traumatic stress disorders. 2nd ed. Cambridge, MA: Hogrefe Publishing; 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Hatcher, MD principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Exposure Therapy and Genealogical Services in people with PTSD, run by University of Ottawa at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability measured by Recruitment Rates (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03781297, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.