NCT03781297

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 11, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

1.4 years

First QC Date

June 20, 2018

Last Update Submit

October 21, 2021

Conditions

Keywords

Homeless PopulationsPTSDNarrative Exposure TherapyIndividual TherapyGenealogy

Outcome Measures

Primary Outcomes (2)

  • Acceptability measured by Recruitment Rates

    The investigators would deem the interventions acceptable if 50% of people approached consented to participate in the study.

    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.

    6 months

Secondary Outcomes (7)

  • Acceptability & Feasibility of Collecting Outcome Data measured by Retention Rates

    6 months

  • Change in Post-Traumatic Stress Disorder (PTSD) symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5)

    Baseline, Week 8, Week 12

  • Change in Housing Status as measured by Self-Report from Participants

    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)

    Baseline, Week 4, Week 8, Week 12

  • Change in Scores for Substance Use/Misuse as measured by the Addiction Severity Index (ASI)

    Baseline, Week 4, Week 8, Week 12

  • +2 more secondary outcomes

Other Outcomes (4)

  • Severity of Attention Deficit Hyperactivity Disorder (ADHD) as measured by the ADHD Self-Report Scale (ASRS)

    Baseline

  • Level of Cognitive Functioning as measured by the Montreal Cognitive Assessment (MoCA)

    Baseline

  • Diagnosis of PTSD as measured by the MINI International Neurpsychiatric Interview

    Baseline

  • +1 more other outcomes

Study Arms (2)

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.

Other: Narrative Exposure TherapyOther: Genealogical Services

Intervention: NET

ACTIVE COMPARATOR

In addition to usual care, participants will receive six sessions of Narrative Exposure Therapy over six weeks.

Other: Narrative Exposure Therapy

Interventions

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.

Intervention: NETIntervention: NET+G

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.

Intervention: NET+G

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

Location

Related Publications (38)

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MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Simon Hatcher, MD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientist

Study Record Dates

First Submitted

June 20, 2018

First Posted

December 19, 2018

Study Start

February 11, 2019

Primary Completion

June 30, 2020

Study Completion

December 31, 2020

Last Updated

October 22, 2021

Record last verified: 2021-10

Locations