Narrative Exposure Therapy Study for PTSD Among the Homeless Population

October 21, 2021 updated by: Dr. Simon Hatcher, University of Ottawa

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1N 6N5
        • University of Ottawa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention: NET+G
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 Therapy
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.
Other: Genealogical Services
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.
Active Comparator: Intervention: NET
In addition to usual care, participants will receive six sessions of Narrative Exposure Therapy over six weeks.
Other: Narrative Exposure Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability & Feasibility of Collecting Outcome Data measured by Retention Rates
Time Frame: 6 months
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.
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
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.
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
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.
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
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.
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

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.
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

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.
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

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.
Baseline, Week 4, Week 8, Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of Attention Deficit Hyperactivity Disorder (ADHD) as measured by the ADHD Self-Report Scale (ASRS)
Time Frame: Baseline
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.
Baseline
Level of Cognitive Functioning as measured by the Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline
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.
Baseline
Diagnosis of PTSD as measured by the MINI International Neurpsychiatric Interview
Time Frame: Baseline
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.
Baseline
Demographic Characteristics as measured by Self-Report
Time Frame: Baseline
Includes assessments of gender identity, age, marital status, ethnicity, primary language, level of education, Canadian Armed Forces membership and sexual identity
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ottawa

Collaborators

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Simon Hatcher, MD, University of Ottawa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2019

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

June 20, 2018

First Submitted That Met QC Criteria

December 17, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017042

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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