Clinical trial NCT03781297: Narrative Exposure Therapy Study for PTSD Among the Homeless Population
Official title: Protocol for a Feasibility Study of Narrative Exposure Therapy in Homeless Individuals With Post-Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: Homeless Populations
PTSD
Narrative Exposure Therapy
Individual Therapy
Genealogy
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: Ottawa Hospital Research Institute
First posted: 2018-12-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Acceptability measured by Recruitment Rates
timeFrame: 6 months
measure: Feasibility measured by Sample Size
timeFrame: 6 months
Secondary outcomes:
measure: Acceptability & Feasibility of Collecting Outcome Data measured by Retention Rates
timeFrame: 6 months
measure: Change in Post-Traumatic Stress Disorder (PTSD) symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline, Week 8, Week 12
measure: Change in Housing Status as measured by Self-Report from Participants
timeFrame: Baseline, Week 4, Week 8, Week 12
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)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in Scores for Substance Use/Misuse as measured by the Addiction Severity Index (ASI)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in Scores for Alcohol Use/Misuse as measured by the Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in Health Care Costs as measured by Self-Report Questionnaire
timeFrame: Baseline, Week 4, Week 8, Week 12
Other outcomes:
measure: Severity of Attention Deficit Hyperactivity Disorder (ADHD) as measured by the ADHD Self-Report Scale (ASRS)
timeFrame: Baseline
measure: Level of Cognitive Functioning as measured by the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline
measure: Diagnosis of PTSD as measured by the MINI International Neurpsychiatric Interview
timeFrame: Baseline
measure: Demographic Characteristics as measured by Self-Report
timeFrame: Baseline
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Simon Hatcher, MD
role: PRINCIPAL_INVESTIGATOR
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