Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000216314
Ethics application status
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Approved
Date submitted
Help: Date submitted
5/02/2026
Date registered
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20/02/2026
Date last updated
Help: Date last updated
16/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
20/02/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Psychological treatment of Posttraumatic Stress Disorder for refugees
Scientific title
Evaluating massed Narrative Exposure Therapy for refugees with PTSD - a pilot feasibility study
Additional trial identifiers [1] 316440 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Posttraumatic Stress Disorder 340553 0
Condition category
Condition code
Mental Health 336749 336749 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention used in this trial will be Narrative Exposure Therapy (NET). NET comprises 7 sessions of therapy (1.5 hours each session), delivered one-on-one over a 3-week period, Session frequency and separation will determined by client preference, however it is anticipated that sessions would usually be separated by at least one day (e.g. a session on Monday would be followed by a session on Wednesday or Thursday). In Session 1, participants’ symptoms are normalized and participants learn about the psychological effects of trauma for refugees. Participants create their Lifeline, denoting significant positive and traumatic events. In Sessions 2-7, participants’ autobiographical narrative is constructed, key traumatic events are identified and processed. NET is the leading evidence-based trauma-focused intervention for posttraumatic stress disorder (PTSD) in refugees and has been evaluated in more than 20 studies.

Psychologists trained in the delivery of Narrative Exposure Therapy will facilitate the intervention. Trial therapists will undergo specific training in delivering all treatment sessions including the use of a protocol-based treatment manual.

The following protocols will be followed to ensure close therapeutic compliance with the treatment manuals used for both the intervention and control conditions: (i) therapists will receive regular clinical supervision; (ii) participant attendance will be recorded by the clinician as part of routine care; (iii) the treatment manuals will be used in all treatment sessions; (iv) with participant consent, all treatment sessions will be video recorded and 10% will be randomly selected and rated for therapist adherence to the manual.
Intervention code [1] 333098 0
Behaviour
Intervention code [2] 333099 0
Treatment: Other
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 344264 0
PTSD (clinician-assessed)
Timepoint [1] 344264 0
Pre-treatment, Post-treatment (i.e., following the completion of session 7 of therapy), 1-month follow-up (i.e., 1-month following treatment completion) and 6-month follow-up. 1 month follow-up is defined as the primary endpoint.
Secondary outcome [1] 457286 0
Depression
Timepoint [1] 457286 0
Pre-treatment, Post-treatment (i.e., following the completion of session 7 of therapy), 1-month follow-up (i.e., 1-month following treatment completion) and 6-month follow-up.
Secondary outcome [2] 457287 0
Functioning
Timepoint [2] 457287 0
Pre-treatment, Post-treatment (i.e., following the completion of session 7 of therapy), 1-month follow-up (i.e., 1-month following treatment completion) and 6-month follow-up.
Secondary outcome [3] 457288 0
Self-identified problems
Timepoint [3] 457288 0
Pre-treatment, Post-treatment, 1-month follow-up (i.e., 1-month following treatment completion) and 6-month follow-up.
Secondary outcome [4] 457716 0
Brief symptom measure
Timepoint [4] 457716 0
Administered verbally at all assessment time-points (pre-treatment, post-treatment, 1-month follow-up, 6-month follow-up), as well as at the beginning of each treatment session.

Eligibility
Key inclusion criteria
Inclusion criteria for participants taking part in this study include:
(a) 18+ years,
(b) from a refugee or asylum seeker background,
(c) able to speak and read Arabic, Farsi, and/or English
(d) PTSD diagnosis (as determined by the PSS-I-5 at Pre-Treatment Assessment)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Exclusion criteria for those who are not eligible to participate in the study include:
(a) participants that do not meet the inclusion criteria
(b) imminent suicide risk or with expressed acute needs/protection risks (e.g., a woman who reports that she is at acute risk of domestic and/or sexual violence),
(c) severe mental disorder (psychotic disorders, substance-dependence),
(d) severe cognitive impairment (e.g., severe intellectual disability, dementia or traumatic brain injury),
(e) concurrent psychological treatment (e.g., currently receiving weekly or fortnightly psychological services from a therapist)
(f) no access to smart phone/laptop with camera and internet connection in order to attend Zoom appointments.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The total sample size for the project is 12 participants from a refugee background.

In case series designs, intensive time series data are collected and analysed at the individual participant level to visually ascertain whether there is within-person change in slope and level of psychological symptoms during the intervention and following the intervention. Where a sufficient number of data points are collected (guidelines suggest best practice for a minimum of 4 data points (Smith, 2012)). These individual time series analyses also have adequate power to test statistically the efficacy of an intervention for an individual participant (Borckardt et al., 2008). In order to achieve this in the current study, multi-level modelling conducted in Mplus (Muthen & Muthen, 2017) will be used to evaluate longitudinal trajectories of symptom change (Smith, 2012). In addition, symptom change will also be evaluated using mixed-effects regression analyses (conducted in SPSS) which compare slopes of changes symptoms and outcomes during the intervention (Arntz et al., 2013).

These time series analyses can also be supplemented by clinically significant change analyses (Jacobson & Truax, 1991). To achieve this, we will use a number of statistical methods. First, repeated measures ANOVAs and chi-square analyses will be used to compare average symptom severity and diagnostic status (respectively) at baseline, treatment and follow-up phases (Dunn et al., 2019). We will also investigate the proportion of participants who show reliable and clinically significant change at post-treatment and follow-up, relative to pre-treatment (Jacobson & Truax, 1991). Finally given the lack of an internal control condition in case series designs, it can be helpful to benchmark the treatment effects against some external comparator (Borckardt et al., 2008). Conventional group level statistical tests can be evaluated to estimate effect sizes, which can be compared against existing randomised control trial (RCT) outcomes for other PTSD interventions.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/04/2026
Actual
21/04/2026
Date of last participant enrolment
Anticipated
1/06/2029
Actual
Date of last data collection
Anticipated
1/12/2029
Actual
Sample size
Target
12
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 321049 0
Government body
Name [1] 321049 0
National Health and Medical Research Council
Country [1] 321049 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 323753 0
None
Name [1] 323753 0
Address [1] 323753 0
Country [1] 323753 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319587 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 319587 0
Ethics committee country [1] 319587 0
Australia
Date submitted for ethics approval [1] 319587 0
27/06/2025
Approval date [1] 319587 0
15/09/2025
Ethics approval number [1] 319587 0
iRECS7819

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 147778 0
Prof Angela Nickerson
Address 147778 0
Refugee Trauma and Recovery Program, School of Psychology, Mathews Building (F23), High Street, UNSW AUSTRALIA, Sydney 2052, NSW
Country 147778 0
Australia
Phone 147778 0
+61 2 9385 0538
Fax 147778 0
Email 147778 0
[email protected]
Contact person for public queries
Name 147779 0
Angela Nickerson
Address 147779 0
Refugee Trauma and Recovery Program, School of Psychology, Mathews Building (F23), High Street, UNSW AUSTRALIA, Sydney 2052, NSW
Country 147779 0
Australia
Phone 147779 0
+61 2 9385 0538
Fax 147779 0
Email 147779 0
[email protected]
Contact person for scientific queries
Name 147780 0
Angela Nickerson
Address 147780 0
Refugee Trauma and Recovery Program, School of Psychology, Mathews Building (F23), High Street, UNSW AUSTRALIA, Sydney 2052, NSW
Country 147780 0
Australia
Phone 147780 0
+61 2 9385 0538
Fax 147780 0
Email 147780 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.