Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000381189
Ethics application status
Approved
Date submitted
22/02/2019
Date registered
11/03/2019
Date last updated
1/09/2024
Date data sharing statement initially provided
11/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Psychological Treatment of Posttraumatic Stress Disorder in Refugees
Scientific title
Evaluating a phase-based intervention for the treatment of PTSD symptoms in refugees .
Secondary ID [1] 297286 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-traumatic Stress Disorder 311363 0
Condition category
Condition code
Mental Health 310001 310001 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a randomised clinical trial with two phases (parallel design). There are 2 active arms in this study: Arm 1- Skills Training in Affective and Interpersonal Regulation (STAIR) (phase 1) and Narrative Exposure Therapy (phase 2); Arm 2- supportive problem-solving (control condition; phase 1) and Narrative Exposure Therapy (phase 2).

In the STAIR treatment sessions, patients learn skills related to emotion regulation, prior to engaging in exposure therapy for PTSD (Cloitre et al., 2002). STAIR sessions have been specifically adapted to suit the refugee context by the study team. NET is currently the leading evidence-based trauma-focused intervention for PTSD relevant to the refugee context (Schauer, Neuner, Elbert, 2011).

Both treatment arms will participate in 13 x 90 minute sessions, scheduled at once per week over 13 weeks. The first 6 sessions (phase 1) will comprise either STAIR or supportive problem-solving (SP) treatment sessions and the following 7 will be NET sessions (phase 2). All treatment sessions will be delivered individually in either a face-to-face format held at the Westmead Institute of Medical Research or via the internet using videoconferencing software on an applicable device (e.g., tablet, computer, smartphone).

The treatment manuals for STAIR and NET have been adapted to suit refugees. The treatment manual for the control condition has been developed specifically for this study and involve supportive problem-solving techniques. Clinical psychologists trained in the delivery of STAIR, supportive problem-solving, and NET will facilitate the interventions. 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 15% will be randomly selected and rated for therapist adherence to the manual.
Intervention code [1] 313538 0
Treatment: Other
Intervention code [2] 313539 0
Behaviour
Comparator / control treatment
Active control: Supportive problem-solving sessions (SP) (phase 1) and Narrative Exposure Therapy (phase 2). Participants will attend 13 x 90 minute sessions, scheduled at once per week over 13 weeks. The first 6 sessions (phase 1) will comprise of SP and the following 7 will be NET sessions (phase 2). All treatment sessions will be delivered individually in either a face-to-face format held at the Westmead Institute of Medical Research or via the internet using videoconferencing software on an applicable device (e.g., tablet, computer, smartphone).

The treatment manuals for NET have been adapted to suit refugees. The treatment manual for the SP sessions has been developed to suit the refugee context specifically for this study. Clinical psychologists trained in the delivery of SP and NET will facilitate the interventions. 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 15% will be randomly selected and rated for therapist adherence to the manual.
Control group
Active

Outcomes
Primary outcome [1] 318993 0
Between-group differences in change in the severity of symptoms of post traumatic stress disorder (PTSD) as measured by scores on the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and PCL-5.
Timepoint [1] 318993 0
Timepoint: Baseline, Post-treatment (1 week following treatment completion); 3 months follow-up (3 months following treatment completion), and at 12-months follow-up (12 months after treatment completion). The 3-month follow-up is the primary time point.
Secondary outcome [1] 366662 0
Between-group differences in change in relation to the proportion of participants remitted from full PTSD as assessed by the CAPS-5.
Timepoint [1] 366662 0
Baseline, Post-treatment (1 week following treatment completion); 3 months follow-up (3 months following treatment completion), and at 12-months follow-up (12 months after treatment completion).
Secondary outcome [2] 366663 0
Between-group differences in change in relation to the proportion of participants remitted from subthreshold/full major depressive disorder (MDD) as assessed by the Mini International Neuropsychiatric Interview for DSM-5 (MINI-5).
Timepoint [2] 366663 0
Baseline, Post-treatment (1 week following treatment completion); 3 months follow-up (3 months following treatment completion), and at 12-months follow-up (12 months after treatment completion).
Secondary outcome [3] 366665 0
Between-group differences in change in the severity of symptoms of complex post traumatic stress disorder (C-PTSD) as measured by scores on the International Trauma Questionnaire (ITQ) and the PCL-5.
Timepoint [3] 366665 0
Baseline, Phase 1 assessment (completed after completing Phase 1: 6 treatment sessions), Post-treatment (1 week following treatment completion); 3 months follow-up (3 months following treatment completion), and at 12-months follow-up (12 months after treatment completion).
Secondary outcome [4] 366666 0
Between-group differences in change in the severity of symptoms of major depressive disorder (MDD) as measured by scores on the Beck Depression Inventory (BDI-II).
Timepoint [4] 366666 0
Baseline, Phase 1 assessment (completed after completing Phase 1: 6 treatment sessions), Post-treatment (1 week following treatment completion); 3 months follow-up (3 months following treatment completion), and at 12-months follow-up (12 months after treatment completion).
Secondary outcome [5] 366667 0
Between-group differences in change in the severity of anxiety symptoms as measured by scores on the Generalised Anxiety Disorder 7- item scale (GAD-7).
Timepoint [5] 366667 0
Baseline, Phase 1 assessment (completed after completing Phase 1: 6 treatment sessions), Post-treatment (1 week following treatment completion); 3 months follow-up (3 months following treatment completion), and at 12-months follow-up (12 months after treatment completion).
Secondary outcome [6] 366668 0
Between-group differences in change in scores on the Difficulties in Emotion Regulation Scale indexing participants ability to manage emotions.
Timepoint [6] 366668 0
Baseline, Phase 1 assessment (completed after completing Phase 1: 6 treatment sessions), Post-treatment (1 week following treatment completion); 3 months follow-up (3 months following treatment completion), and at 12-months follow-up (12 months after treatment completion).
Secondary outcome [7] 366669 0
Between-group differences in change in scores on the Interpersonal Regulation Questionnaire (IRQ) indexing participants capacity for social emotion regulation.
Timepoint [7] 366669 0
Baseline, Phase 1 assessment (completed after completing Phase 1: 6 treatment sessions), Post-treatment (1 week following treatment completion); 3 months follow-up (3 months following treatment completion), and at 12-months follow-up (12 months after treatment completion).
Secondary outcome [8] 366670 0
Between-group differences in change in scores on the World Health Organisation Quality of Life (WHOQOL-BREF) indexing participants quality of life.
Timepoint [8] 366670 0
Baseline, Phase 1 assessment (completed after completing Phase 1: 6 treatment sessions), Post-treatment (1 week following treatment completion); 3 months follow-up (3 months following treatment completion), and at 12-months follow-up (12 months after treatment completion).
Secondary outcome [9] 368004 0
Between-group differences in change in scores on the White Bear Suppression Inventory indexing participants ability to manage emotions.
Timepoint [9] 368004 0
Baseline, Phase 1 assessment (completed after completing Phase 1: 6 treatment sessions), Post-treatment (1 week following treatment completion); 3 months follow-up (3 months following treatment completion), and at 12-months follow-up (12 months after treatment completion).
Secondary outcome [10] 368005 0
Between-group differences in change in scores on the Emotion Regulation Questionnaire indexing participants ability to manage emotions.
Timepoint [10] 368005 0
Baseline, Phase 1 assessment (completed after completing Phase 1: 6 treatment sessions), Post-treatment (1 week following treatment completion); 3 months follow-up (3 months following treatment completion), and at 12-months follow-up (12 months after treatment completion).

Eligibility
Key inclusion criteria
Inclusion criteria
(i) Aged over 18 years old
(ii) A refugee or asylum-seeker background
(iii) Fluent and literate in Arabic, Farsi or Dari
(iv) Meet criteria for PTSD diagnosis (according to DSM-5)
(v) If on concurrent pharmacological treatment they will be on a stable dose for one month prior to completing their initial assessment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
(i) Individuals experiencing active suicidality (intent and/or a previous suicide attempt in the past three months)
(ii) Active psychosis or alcohol/substance dependence
(ii) Moderate to severe traumatic brain injury

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The person generating the allocation sequence will be independent of the study team. Following determination of eligibility (i.e., upon completion of the participants initial assessment interview), the research coordinator will input the necessary data needed to generate the allocation (as described in the 'sequence generation' section) into a computerised system. The computerised system will reveal the allocation sequence to the project coordinator who will inform the project psychologists only. Those conducting the outcome assessments at post, 3- and 12-month follow-up interviews, will remain blind to allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be based on a 1:1 allocation ratio (with 2 groups). To ensure balance between groups the allocation will be stratified by visa status (secure visa holders vs. insecure visa holders). The allocation sequence will be generated by a person independent of the study team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The final sample in this study will comprise 128 participants. A previous study found a between-groups (STAIR+ Prolonged Exposure vs. control treatment sessions + PE) pre to post-treatment effect size of 0.73 on the Clinician Administered PTSD Scale (Cloitre et al., 2010). We conservatively expect an effect size of at least d=0.65 when comparing STAIR-R+Narrative Exposure Therapy (NET) and supportive problem-solving (SP)+NET . This would correspond to a decrease of 15% of PTSD symptom severity following STAIR-R+NET over and above that conferred by exposure therapy, representing a significant clinical outcome. To detect an effect size of 0.65, with 80% power at a=.05, we calculated a necessary sample size of 64 participants per condition. On the basis of previous randomized controlled trials of trauma-focused interventions with refugees (e.g., Neuner et al., 2010; Paunovic & Ost, 2001; Stenmark, Catani, Neuner, Elbert, & Holen, 2013), we conservatively estimate that 70% of participants will be retained at the 12 month follow-up assessment. Accordingly, to ensure adequate power, we will recruit 168 patients.

Analysis
Impact of interventions on mental health. Mixed-effects regression analyses will be used to investigate the relative impact of the two intervention arms on change in PTSD symptoms, depression symptoms, complex PTSD symptoms, anxiety symptoms, emotion regulation difficulties, social emotion regulation, and quality of life from baseline to post-treatment and follow-up assessment points. In this study, we will estimate change in the outcome variables relating to treatment condition over time.

Effect sizes and clinical significance. We will calculate treatment effect sizes for each outcome variable to determine the magnitude of the difference between treatment arms and across treatment sessions. We will conduct chi-square analyses to compare the proportion of participants who continue to meet PTSD and MDD criteria in each treatment condition.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
27/03/2019
Actual
10/04/2019
Date of last participant enrolment
Anticipated
31/07/2024
Actual
7/11/2023
Date of last data collection
Anticipated
30/11/2025
Actual
Sample size
Target
168
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 301845 0
Government body
Name [1] 301845 0
NHMRC
Country [1] 301845 0
Australia
Primary sponsor type
Individual
Name
Professor Angela Nickerson
Address
School of Psychology
UNSW Sydney
Sydney NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 301590 0
None
Name [1] 301590 0
Address [1] 301590 0
Country [1] 301590 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302545 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 302545 0
Ethics committee country [1] 302545 0
Australia
Date submitted for ethics approval [1] 302545 0
19/07/2018
Approval date [1] 302545 0
01/11/2018
Ethics approval number [1] 302545 0
HC180551

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

Contacts
Principal investigator
Name 90594 0
A/Prof Angela Nickerson
Address 90594 0
Refugee Trauma and Recovery Program, School of Psychology, Mathews Building (F23), High Street, UNSW AUSTRALIA, Sydney, NSW, 2052
Country 90594 0
Australia
Phone 90594 0
+61 2 9385 0538
Fax 90594 0
Email 90594 0
[email protected]
Contact person for public queries
Name 90595 0
Angela Nickerson
Address 90595 0
Refugee Trauma and Recovery Program, School of Psychology, Mathews Building (F23), High Street, UNSW AUSTRALIA, Sydney, NSW, 2052
Country 90595 0
Australia
Phone 90595 0
+61 02 9065 7755
Fax 90595 0
Email 90595 0
[email protected]
Contact person for scientific queries
Name 90596 0
Angela Nickerson
Address 90596 0
Refugee Trauma and Recovery Program, School of Psychology, Mathews Building (F23), High Street, UNSW AUSTRALIA, Sydney, NSW, 2052
Country 90596 0
Australia
Phone 90596 0
+61 2 9385 0538
Fax 90596 0
Email 90596 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.