Condition category
Mental and Behavioural Disorders
Date applied
31/01/2017
Date assigned
08/02/2017
Last edited
12/02/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Forced migrants often experience a large number of traumatic events. Studies have found that asylum-seekers and refugees report high rates of post-traumatic stress disorder (PTSD; a type of anxiety disordered triggered by a traumatic event). Human trafficking is a form of modern slavery that involves the forced movement of people either internally within countries, or externally across borders. Victims who are trafficked are similarly subject to repeated, multiple trauma, and high rates of mental health problems including PTSD have been found. Narrative Exposure Therapy (NET) is a type of therapy for individuals who have PTSD following multiple traumatic events. This treatment aims to alleviate the symptoms of PTSD, thereby leading to an improvement in daily functioning. Whilst good evidence for its use in conflict zones exists and its efficacy amongst individuals who have left their countries of origin is emerging, little research has focused on its efficacy amongst victims of trafficking. The aim of this study is to evaluate how well this therapy works for different groups of people who have all experienced multiple traumas, and to make sure they are treated in the most efficient and effective way.

Who can participate?
Adult victims of human trafficking and other forced migrants.

What does the study involve?
Participants are randomly allocated to either start therapy straight away, or placed into the ‘waiting list’ group to start therapy about six months later. Once receiving therapy, participants are offered up to 20 sessions. Throughout the duration of the research study, participants are routinely asked to fill out questions about their mental health and well-being. This includes questions about particular symptoms they may be having, such as nightmares, and asking them to rate statements such as “Worrying thoughts go through my mind”. Interpreters can be arranged where needed. The same set of questions are asked again at three, six and twelve months after having finished therapy to find out how things change for patients over time.

What are the benefits and risks of participating?
Participants may benefit from an improvement to their PTSD symptoms after having NET. There are no notable risks involved with participating in this study.

When is the study run from?
Helen Bamber Foundation (UK)

When is the study starting and how long is it expected to run for?
December 2016 to December 2018

Who is funding the study?
The Oak Foundation (UK)

Who is the main contact?
Professor Cornelius Katona

Trial website

Contact information

Type

Scientific

Primary contact

Prof Cornelius Katona

ORCID ID

Contact details

Helen Bamber Foundation
Bruges Place
15-20 Baynes Street
London
NW1 0FT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8331/002

Study information

Scientific title

Treating Post-traumatic Stress Disorder in Victims of Trafficking and other Forced Migrants using Narrative Exposure Therapy: A Pilot Randomized Controlled Trial

Acronym

Study hypothesis

Participants in the treatment condition (Narrative Exposure Therapy) will have significantly reduced symptoms of Post-traumatic Stress Disorder in comparison to waitlist controls.

Ethics approval

University College London (UCL) Ethics Committee, 30/01/2017, ref: 8133/002

Study design

Single-centre blinded randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

See additional files

Condition

Post-traumatic Stress Disorder in victims of trafficking and other forced migrants.

Intervention

Eligible participants will be randomized to either Narrative Exposure Therapy (N=15-20) or the waitlist control group (N=15-20). Randomization will be performed using stratification for victims of trafficking vs other forced migrants. It is intended to perform blinded assessments by keeping raters unaware of treatment condition and by instructing clients not to reveal treatment conditions if possible.

Participants in the treatment condition will be offered up to 20 sessions of NET. The anticipated average number of sessions is 16. Additional time will be allowed for participants needing an interpreter, and allow for additional sessions, if NET needs to be paused or if other issues come up during the course of treatment that need more urgent attention (such as concerns about legal or practical matter, as is common with this client group). Any additional sessions used for non-NET purposes will be noted, and the content of this will be documented.

Participants in the waitlist control condition will receive the same treatment approximately six months later.

Participants in both groups will be followed up at three, six, and twelve months.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Post-traumatic Stress Disorder rate is measured using the Clinician-administered PTSD Scale (CAPS-5) and the Post-traumatic Stress Disorder Checklist (PCL-5) at baseline, midway through treatment (after 8 sessions), after 16 sessions, at the end of treatment (if this is more than 16 sessions), and at three, six and twelve month follow-up.

Secondary outcome measures

1. Depression is measured using Patient Health Questionnaire (PHQ-9)
2. Anxiety is measured using Generalised Anxiety Disorder (GAD-7)
3. Dissociation is measured using Shutdown Dissociation Scale (ShuDis)
4. Levels of generalized distress is measured using Clinical Outcomes in Routine Evaluation (CORE)
5. Self-Compassion using the Self-compassion Scale short from (SCS-SF)
6. Rumination is measured using Preservative Thinking Questionnaire (PTQ) and the Self-Critical Rumination Scale (SCRS)
7. Self-esteem is measured using Rosenberg Self-Esteem
8. General daily functioning and satisfaction is measured using Work and Social Adjustment Scale (WASA)

All outcomes will be measured at baseline, midway through treatment (after 8 sessions), after 16 sessions, at the end of treatment (if this is more than 16 sessions), and at three, six and twelve month follow-up.

Overall trial start date

01/12/2016

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of Post-traumatic Stress disorder according to DSM 5
2. A history of human trafficking or other human rights abuses
3. Provision of informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30-40

Participant exclusion criteria

Any internal or external factors that indicate the person is not stable enough for trauma-focused treatment to be appropriate (in accordance with NICE Guidelines for PTSD, 2005). This will include comorbid psychosis, substance misuse and high risk of suicide and/or self-harm, as well as destitution, street homelessness, risk of imminent removal from the UK and the inability of parents to organise childcare due to safeguarding and attendance issues.

Recruitment start date

01/03/2017

Recruitment end date

30/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Helen Bamber Foundation
Bruges Place 15-20 Baynes Street
London
NW1 0TF
United Kingdom

Sponsor information

Organisation

Helen Bamber Foundation

Sponsor details

Bruges Place
15-20 Baynes Street
London
NW1 0TF
United Kingdom
+44 20 3058 2020
reception@helenbamber.org

Sponsor type

Charity

Website

http://www.helenbamber.org/

Funders

Funder type

Charity

Funder name

The Oak Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Plans to publish the results in an academic journal. It will not be possible to identify individual participants here as data will have been anonymised. All research participants will also be written to using simplified language to inform them of the results.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Cornelius Katona, cornelius@helenbamber.org

Intention to publish date

31/12/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Editorial Notes

12/02/2018: The following changes were made: 1. Recruitment end date was changed from 01/01/2018 to 30/06/2018. 2. Overall trial end date was changed from 01/04/2018 to 31/12/2018. 3. Intention to publish date was changed from 30/04/2019 to 31/12/2019. 21/02/2017: Participant information sheets uploaded.