Ignite Creation Date:
2024-05-06 @ 12:33 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03781297
Status:
COMPLETED
Last Update Posted:
2021-10-22
First Post:
2018-06-20
Brief Title:
Narrative Exposure Therapy Study for PTSD Among the Homeless Population
Sponsor:
University of Ottawa
Organization:
University of Ottawa
Study Overview
Official Title:
Protocol for a Feasibility Study of Narrative Exposure Therapy in Homeless Individuals With Post-Traumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 6825 people using 500191 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
In Ottawa in 2015 there were 6825 people using 500191 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 Centres 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 Ottawas 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 11 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 procedures will take place at shelters served by the Royal Ottawa Mental Health Centres 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 Ottawas 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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None