Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001048774
Ethics application status
Approved
Date submitted
19/07/2022
Date registered
28/07/2022
Date last updated
18/08/2024
Date data sharing statement initially provided
28/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Psychological Treatment of Posttraumatic Stress Disorder and Moral Injury in Refugees
Scientific title
Evaluation of a psychological intervention for the treatment of PTSD and moral injury-related symptoms in Arabic, Dari, Farsi and English-speaking adult refugees.
Secondary ID [1] 307618 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder 327093 0
Moral Injury 327094 0
Condition category
Condition code
Mental Health 324241 324241 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention used in this study will be the Moral Injury Treatment for Refugees (MIT-R). The aim of this clinical study is to assess if MIT-R is effective in reducing post-traumatic stress disorder symptoms, reducing negative moral emotions (i.e., anger, shame, and guilt) and increasing social functioning in a group of Arabic, Dari, Farsi and English-speaking refugees. MIT-R was developed in consultation with refugee community leaders and service providers. We drew on evidence-based strategies from existing interventions focused on moral injury, anger, guilt and shame, as well as interventions adapted to the refugee context. This study will utilise a randomised multiple baseline case series design, where participants will be randomised to a baseline length of 4, 6, or 8 weeks before receiving the intervention. MIT-R comprises 12 weekly sessions (1.5 hours each session) for individuals and will be delivered online via Zoom. This intervention comprises four phases: Psychoeducation- in this phase, participants’ symptoms are normalised and participants learn about the psychological effects of traumatic events and morally injurious events for refugees; Narrative Exposure Therapy: in this phase, participants’ autobiographical narrative is constructed, key morally injurious/traumatic events are identified and processed. Narrative Exposure Therapy is the leading evidence-based trauma-focused intervention for PTSD in refugees and has been evaluated in more than 20 studies; Culturally-Informed Cognitive Therapy: In this phase, moral injury appraisals are situated within participants’ personal and cultural moral frameworks and addressed using evidence-based cognitive techniques for reducing negative emotions; Reconnecting with Community: In this phase, functional implications of moral injury appraisals are identified; participants re-connect with important relationships and cultural values; an action plan is developed to facilitate increased future engagement in life and with community, consistent with existing treatments of moral injury in non-refugee populations.

The treatment manual for MIT-R has been adapted to suit Arabic, Dari, Farsi and English-speaking refugees. Psychologists trained in the delivery of MIT-R and Narrative Exposure Therapy 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 manual: (i) therapists will receive regular clinical supervision; (ii) participant attendance will be recorded by the clinician as part of routine care; (iii) the treatment manual 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] 324064 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332061 0
PTSD diagnosis as measured by the PTSD Symptom Scale Interview for the DSM-5 (PSS-I-5).
Timepoint [1] 332061 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention). Post-treatment is defined as the primary endpoint.
Primary outcome [2] 332062 0
Posttraumatic stress symptoms as measured by the PTSD Symptom Scale Interview for the DSM-5 (PSS-I-5).
Timepoint [2] 332062 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention). Post-treatment is defined as the primary endpoint.
Primary outcome [3] 332084 0
Posttraumatic stress symptoms as measured by the PTSD-8 (PTSD-8).
Timepoint [3] 332084 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention). Additionally, the PTSD-8 is completed weekly throughout the baseline and treatment phases. Post-treatment is defined as the primary endpoint.
Secondary outcome [1] 412030 0
Trauma-related anger as measured by a single item indexing trauma-related anger.
Timepoint [1] 412030 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention). Additionally, this item is completed weekly throughout the baseline and treatment phases.
Secondary outcome [2] 412031 0
Trauma-related shame as measured by a single item indexing trauma-related shame.
Timepoint [2] 412031 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention). Additionally, this item is completed weekly throughout the baseline and treatment phases.
Secondary outcome [3] 412033 0
Moral injury-related outcomes as measured by the Moral Injury Outcome Scale (MIOS).
Timepoint [3] 412033 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention).
Secondary outcome [4] 412034 0
Social Functioning as measured by the Brief Inventory of Psychosocial Functioning (BIPF).
Timepoint [4] 412034 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention).
Secondary outcome [5] 412035 0
Moral injury appraisals as measured by the Moral Injury Appraisals Scale (MIAS).
Timepoint [5] 412035 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention).
Secondary outcome [6] 412140 0
Generalised anger as measured by the Dimensions of Anger Reactions-5 (DAR-5).
Timepoint [6] 412140 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention).
Secondary outcome [7] 412141 0
Trauma-related shame cognitions as measured by the Trauma-Related Shame Inventory-short form (TRSI-SF).
Timepoint [7] 412141 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention).
Secondary outcome [8] 412142 0
Generalised shame as measured by the Personal Feelings Questionnaire (PFQ-2).
Timepoint [8] 412142 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention).
Secondary outcome [9] 412143 0
Trauma-related guilt cognitions as measured by the Trauma-Related Guilt Inventory-short form (TRGI-SF).
Timepoint [9] 412143 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention).
Secondary outcome [10] 412144 0
Generalised guilt as measured by the Personal Feelings Questionnaire (PFQ-2).
Timepoint [10] 412144 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention).
Secondary outcome [11] 412145 0
Social engagement as measured by the Adapted Social Capital Assessment (SASCAT).
Timepoint [11] 412145 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention).
Secondary outcome [12] 412146 0
Social wellbeing as measured by a single item from the WHO Quality of Life Scale (WHOQOL).
Timepoint [12] 412146 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention). Additionally, this item is completed weekly throughout the baseline and treatment phases.
Secondary outcome [13] 416422 0
Depression symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [13] 416422 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention). Additionally, a single item from this scale is completed weekly throughout the baseline and treatment phases.
Secondary outcome [14] 426588 0
Positive social support as measured by the Positive Social Support Scale (PSS).
Timepoint [14] 426588 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention).
Secondary outcome [15] 426589 0
Negative social support as measured by the Negative Social Support Scale (NSS).
Timepoint [15] 426589 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention).
Secondary outcome [16] 426590 0
Acceptance and experiential avoidance as measured by the Acceptance and Action Questionnaire-II (AAQ-II).
Timepoint [16] 426590 0
Baseline (before baseline length allocation), Pre-treatment (after baseline completion), Post-treatment and follow-up (3 months post-completion of intervention).

Eligibility
Key inclusion criteria
Inclusion criteria for participants taking part in this study include:
1. 18 years of age or older
2. PTSD diagnosis (according to DSM-5)
3. Exposure to a potentially morally injurious experience
4. Elevated trauma-related anger, shame or guilt
5. From a refugee or asylum seeker background
6. Fluent in Arabic, Dari, Farsi or English
7. Access to a smart phone, tablet or computer in order to complete sessions via telehealth on Zoom.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for those who are not eligible to participate in the study include:
1. Acute suicidality that cannot be safely managed in the clinic setting (i.e., intent and/or previous suicide attempt in the past three months).
2. Active/untreated psychosis
3. Alcohol or Substance dependence
4. Moderate to Severe Traumatic Brain Injury
5. Concurrent regular psychological therapy

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)
Participants will be randomly allocated to baseline length using computer software. Allocation to baseline length will be conducted after participant eligibility has been confirmed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation methods will be used via computer software to ensure an equal amount of participants are assigned to each baseline length (4, 6 or 8 weeks).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A randomised, multiple baseline design will be used in this study, where participants are randomly allocated to a baseline length of either 4, 6, or 8 weeks. Assessments will be completed at Baseline (before baseline length randomisation), Pre-treatment (after baseline length completion), Post-treatment and follow-up (3 months after treatment is complete). During baseline and treatment phases, weekly symptom questionnaires (PTSD, anger, shame, guilt, depression and social wellbeing) will be administered.
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 who speak either Arabic, Dari, Farsi or English, comprising 10 participants who undertake the intervention, and allowing for two who may either not show a stable pattern of PTSD during the baseline phase or drop-out during the baseline phase. If more than two participants either fail to show a stable pattern of PTSD during the baseline phase, or drop-out during the baseline phase, we will recruit more participants until 10 complete the baseline phase.

This sample size is sufficient to meet the research aims and answer the research questions because 10 participants would provide 80% power to detect a large (d = 1.0) treatment effect at alpha = 0.05 for a paired-samples t-test performed on pre- to post-treatment scores. Other studies that have implemented analogous exposure-based and cognitive techniques to reduce PTSD symptoms in refugees have found large within-subjects effects (d = 1.5 to 3.0). Furthermore, other studies have demonstrated that 10 participants with a minimum of 4 datapoints each provides adequate power to determine the effectiveness of an intervention using a case series design. We will only include participants in the final analyses who met diagnostic criteria for PTSD at both the Baseline and Pre-treatment assessments.

In this study, multi-level modelling and mixed-effects regression analyses will be used to evaluate longitudinal trajectories of symptom change and compare slopes of changes in moral injury appraisals and outcomes during baseline and treatment phases. We will also undertake clinically significant change analyses to investigate the proportion of participants who show reliable and clinically significant change at post-treatment and follow-up, relative to pre-treatment.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/11/2022
Actual
16/01/2023
Date of last participant enrolment
Anticipated
1/09/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
12
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311882 0
Charities/Societies/Foundations
Name [1] 311882 0
Psyche Foundation
Country [1] 311882 0
Australia
Primary sponsor type
Individual
Name
Professor Angela Nickerson
Address
School of Psychology
Mathews Building (Entry via Gate 11 Botany St)
UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 313360 0
University
Name [1] 313360 0
UNSW Sydney
Address [1] 313360 0
School of Psychology
UNSW Sydney NSW 2052
Country [1] 313360 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311317 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 311317 0
Ethics committee country [1] 311317 0
Australia
Date submitted for ethics approval [1] 311317 0
04/07/2022
Approval date [1] 311317 0
01/08/2022
Ethics approval number [1] 311317 0

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

Contacts
Principal investigator
Name 120690 0
Prof Angela Nickerson
Address 120690 0
Refugee Trauma and Recovery Program,
School of Psychology,
Mathews Building (F23), High Street
UNSW AUSTRALIA, Sydney 2052, NSW
Country 120690 0
Australia
Phone 120690 0
+61 2 9385 0538
Fax 120690 0
Email 120690 0
[email protected]
Contact person for public queries
Name 120691 0
Angela Nickerson
Address 120691 0
Refugee Trauma and Recovery Program,
School of Psychology,
Mathews Building (F23), High Street
UNSW AUSTRALIA, Sydney 2052, NSW
Country 120691 0
Australia
Phone 120691 0
+61 2 9385 0538
Fax 120691 0
Email 120691 0
[email protected]
Contact person for scientific queries
Name 120692 0
Angela Nickerson
Address 120692 0
Refugee Trauma and Recovery Program,
School of Psychology,
Mathews Building (F23), High Street
UNSW AUSTRALIA, Sydney 2052, NSW
Country 120692 0
Australia
Phone 120692 0
+61 2 9385 0538
Fax 120692 0
Email 120692 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.