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Trial registered on ANZCTR


Registration number
ACTRN12620000909921
Ethics application status
Approved
Date submitted
22/07/2020
Date registered
14/09/2020
Date last updated
28/10/2024
Date data sharing statement initially provided
14/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The March 15 Study: Examining the impacts and recovery from the March 15 2019 Christchurch Mosque attacks in people most directly exposed and their adult family members
Scientific title
The March 15 Study: Examining the impacts and recovery from the March 15 2019 Christchurch Mosque attacks in people most directly exposed and their adult family members
Secondary ID [1] 301845 0
Nil known
Universal Trial Number (UTN)
U1111-1255-8902
Trial acronym
M15
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
depression 318329 0
anxiety 318330 0
PTSD 318331 0
Psychological distress 318332 0
Post traumatic growth 318333 0
Condition category
Condition code
Mental Health 316344 316344 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 316345 316345 0 0
Anxiety
Mental Health 316346 316346 0 0
Depression
Mental Health 316347 316347 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The exposure is the Mosque attacks in Christchurch on March 15 2019.
Assessments will be at 1-2 years and at 6-8 years post the attacks.
The change to the date of the second assessments to 6-8 years post the attacks, was made in August 2024 before enrolment of any participants these assessments.

Interviews will involve a Muslim Research Assistant and a specialist mental health nurse, and will be completed face-to-face or using Zoom according to participant preference and Covid-19 restrictions.
The nurse will complete a semi-structured diagnostic interview using the MINI. Participants will complete self-report measures of:

Current social and demographic factors
Ethnicity, years in NZ, family composition
Measure of quality of life – Personal Wellbeing Index
Measure of social support – PhenX Toolkit (Measures incorporated in this study were selected from the PhenX Toolkit version June 4, 2019, Ver 26.0.)
Perceived Discrimination Scale
Measure of functioning - Work and Social Adjustment Scale (WSAS)

Measure of exposure and impacts
Whether injured and/or bereaved and measure of previous exposure to trauma
Mental health and wellbeing measures
Wellbeing – WHO-5 Wellbeing Index
Measure of psychological distress – Kessler 10
Measure of PTSD – Post traumatic Checklist for DSM5 – PCL
Measure of somatic symptoms - Somatic Symptom Scale

Resilience and post-traumatic growth
Religious coping scale
Post traumatic growth - Post traumatic growth inventory
Covid-19 Impacts Scale

Other measures
The research will include a measure of how acceptable the interview process was.
We will also obtain consent to access participant’s NHI number to compare the number of times they saw a doctor or other health provider 5 years before and after the 15th March (attendances).

A qualitative study in 40 participants from 4 different types of exposure (bullet-injured, bereaved, witnesses and family members) will explore impacts of the attacks, the impacts of other stressors, what has been helpful and resilience.

Intervention code [1] 318141 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324790 0
Prevalence in the cohort of PTSD from the MINI diagnostic interview.
Timepoint [1] 324790 0
First assessment 1-2 years, and subsequent at 4-5 years post Mosque attacks
Primary outcome [2] 324791 0
Prevalence in the cohort of major depression from the MINI diagnostic interview.
Timepoint [2] 324791 0
First assessment 1-2 years, and subsequent assessment 6-8 years post Mosque attacks.
Primary outcome [3] 324792 0
Prevalence in the cohort of generalised anxiety disorder from the MINI diagnostic interview.
Timepoint [3] 324792 0
First assessment 1-2 years, and subsequent assessment 6-8 years post Mosque attacks.
Secondary outcome [1] 385753 0
Prevalence in the cohort of panic disorder from the MINI diagnostic interview.
Primary outcome
Timepoint [1] 385753 0
First assessment 1-2 years, and subsequent assessment 6-8 years post Mosque attacks.
Secondary outcome [2] 385754 0
Prevalence in the cohort of social phobia from the MINI diagnostic interview.
Primary outcome
Timepoint [2] 385754 0
First assessment 1-2 years, and subsequent assessment 6-8 years post Mosque attacks.
Secondary outcome [3] 385755 0
Prevalence in the cohort of agoraphobia from the MINI diagnostic interview.
Primary outcome
Timepoint [3] 385755 0
First assessment 1-2 years, and subsequent assessment 6-8 years post Mosque attacks.
Secondary outcome [4] 385756 0
Prevalence in the cohort of OCD from the MINI diagnostic interview.
Primary outcome
Timepoint [4] 385756 0
First assessment 1-2 years, and subsequent assessment 6-8 years post Mosque attacks.
Secondary outcome [5] 385762 0
Prevalence in the cohort of bipolar disorder from the MINI diagnostic interview.
Primary outcome
Timepoint [5] 385762 0
First assessment 1-2 years, and subsequent assessment 6-8 years post Mosque attacks.
Secondary outcome [6] 385763 0
Prevalence in the cohort of psychotic disorder from the MINI diagnostic interview.
Primary outcome
Timepoint [6] 385763 0
First assessment 1-2 years, and subsequent assessment 6-8 years post Mosque attacks.
Secondary outcome [7] 385764 0
Prevalence in the cohort of substance use disorder from the MINI diagnostic interview.
Primary outcome
Timepoint [7] 385764 0
First assessment 1-2 years, and subsequent assessment 6-8 years post Mosque attacks.
Secondary outcome [8] 385765 0
Number of attendances for health contact from participants unique NHI (National Health Index) records.
Timepoint [8] 385765 0
For the 5 years before and after the attacks
Secondary outcome [9] 385766 0
Measure of wellbeing - WHO5 Wellbeing Index
Timepoint [9] 385766 0
First assessment 1-2 years, and subsequent assessment 6-8 years post Mosque attacks.
Secondary outcome [10] 385767 0
Measure of psychological distress- Kessler 10
Timepoint [10] 385767 0
First assessment 1-2 years, and subsequent assessment 6-8 years post Mosque attacks.
Secondary outcome [11] 385768 0
Measure of PTSD - Post-traumatic Checklist for DSM5 - PCL5
Timepoint [11] 385768 0
First assessment 1-2 years, and subsequent assessment 6-8 years post Mosque attacks.
Secondary outcome [12] 385769 0
Measure of somatic symptoms - Somatic Symptom Scale
Timepoint [12] 385769 0
First assessment 1-2 years, and subsequent assessment 6-8 years post Mosque attacks.
Secondary outcome [13] 385770 0
Measure of functioning - Work and Social Adjustment Scale - WSAS
Timepoint [13] 385770 0
First assessment 1-2 years, and subsequent assessment 6-8 years post Mosque attacks.
Secondary outcome [14] 385771 0
Measure of quality of life - Personal Wellbeing Index
Timepoint [14] 385771 0
First assessment 1-2 years, and subsequent assessment 6-8 years post Mosque attacks.
Secondary outcome [15] 385772 0
Measure of post-traumatic growth - Post-traumatic Growth Inventory - PTGI
Timepoint [15] 385772 0
First assessment 1-2 years, and subsequent assessment 6-8 years post Mosque attacks.
Secondary outcome [16] 385773 0
Measure of impact of Covid-19- Covid Impacts Scale
Timepoint [16] 385773 0
First assessment 1-2 years, and subsequent assessment 6-8 years post Mosque attacks.
Secondary outcome [17] 385774 0
Measure of suicidality from MINI
Timepoint [17] 385774 0
First assessment 1-2 years, and subsequent assessment 6-8 years post Mosque attacks.
Secondary outcome [18] 385803 0
A qualitative component to the study in 40 participants with 4 different types of exposure ( bullet injured, bereaved, witnesses and family members) will explore the impacts of the attacks, the impacts of other stressors including Covid-19, what has been helpful and resilience. This will involve a research nurse and Muslim research assistant conducting a semi-structured interview.
Following transcription of the interviews a Thematic Analysis (TA) will be conducted. The first step in TA involves becoming closely familiar with the data by reading and re-reading the interview transcripts. Following this close reading, initial codes are generated. The codes are then clustered into related ideas to identify themes.
Timepoint [18] 385803 0
This will be at the first assessment 1-2 years post the attacks.

Eligibility
Key inclusion criteria
1.Through the support of the Muslim community and leadership, all of the surviving adults in Christchurch (aged over 18) who were in (or nearby) either of the two Mosques at the time of the shooting on 15th March 2019 will be invited to participate in the study.
2.We will also invite participation from close relatives (spouses, parents, children over the age of 18 and siblings) of those who died or close relatives (spouses, parents, children over the age of 18 and siblings) of someone who was present at one of the mosques on that day.
3. From 21.4.21, the inclusion criteria expanded to to include adults from the local Muslim community who were in Christchurch at the time of the mosque attacks in 2019.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those under 18 years.
Those not exposed as described in inclusion criteria above.
Those exposed (as above) but not now in Christchurch

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
The reporting of results will follow current best-practice, including utilisation of the STROBE guidelines (see: www.strobe-statement.org). Participant recruitment and retention will be collected and assessed in relation to the target population. Attrition will also be formally assessed (using apposite logistic or binomial GEE models) to ascertain whether there are important differential drop-out rates, and whether methods (such as multiple imputation) may have utility as a sensitivity analysis. Initial analyses will determine the prevalence of major mental disorders in the cohort (major depression; anxiety disorder/PTSD). Logistic regression analyses will be used to predict mental disorders as a function of pre-event characteristics (sex, ethnicity; years in NZ; family composition, prior mental health, post-migration difficulties, language proficiency), trauma exposure and peri-traumatic stress, and post event social support and resilience. Ordinary least squares regression analyses will be used to predict grief, somatic symptoms, post-traumatic growth as a function of pre-event characteristics, trauma exposure, current mental health, post event social support, resilience and spirituality. Rates of attendance at GP clinics and DHB services will be compared pre and post event from participants NHI. Rates of major mental disorder discovered at screening will be compared with rates presenting for treatment to determine the undiagnosed/untreated burden of mental health difficulties. The Covid-19 Impacts Scale items will be analysed using Confirmatory Factor Analysis techniques to ascertain whether they fit a single factor model.  If this is found to be the case, factor scores representing overall Covid exposure (inclusive of both virus exposure and stress/adverse outcomes associated with being in lockdown) will be calculated, and used as a covariate factor in analyses of the March 15th study cohort.  Thematic analysis will be used for the qualitative component.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/09/2020
Actual
28/09/2020
Date of last participant enrolment
Anticipated
24/08/2027
Actual
Date of last data collection
Anticipated
24/08/2027
Actual
Sample size
Target
800
Accrual to date
190
Final
Recruitment outside Australia
Country [1] 22780 0
New Zealand
State/province [1] 22780 0
Canterbury

Funding & Sponsors
Funding source category [1] 306270 0
Government body
Name [1] 306270 0
Health Research Council of New Zealand
Country [1] 306270 0
New Zealand
Funding source category [2] 312119 0
Charities/Societies/Foundations
Name [2] 312119 0
Canterbury Research Medical Foundation
Country [2] 312119 0
New Zealand
Funding source category [3] 312120 0
University
Name [3] 312120 0
University of Otago Research Grant
Country [3] 312120 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith Street, North Dunedin, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 306759 0
None
Name [1] 306759 0
Address [1] 306759 0
Country [1] 306759 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306477 0
New Zealand Health and Disability Ethics Committees
Ethics committee address [1] 306477 0
Ethics committee country [1] 306477 0
New Zealand
Date submitted for ethics approval [1] 306477 0
30/04/2020
Approval date [1] 306477 0
01/07/2020
Ethics approval number [1] 306477 0
19/NTA/147

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

Contacts
Principal investigator
Name 104026 0
Prof Caroline Bell
Address 104026 0
Department of Psychological Medicine
University of Otago Christchurch
PO Box 4345
Christchurch
8140
Country 104026 0
New Zealand
Phone 104026 0
+64 3 3726700
Fax 104026 0
NA
Email 104026 0
caroline.bell@otago.ac.nz
Contact person for public queries
Name 104027 0
Caroline Bell
Address 104027 0
Department of Psychological Medicine
University of Otago Christchurch
PO Box 4345
Christchurch
8140
Country 104027 0
New Zealand
Phone 104027 0
+64 3 3726700
Fax 104027 0
NA
Email 104027 0
caroline.bell@otago.ac.nz
Contact person for scientific queries
Name 104028 0
Caroline Bell
Address 104028 0
Department of Psychological Medicine
University of Otago Christchurch
PO Box 4345
Christchurch
8140
Country 104028 0
New Zealand
Phone 104028 0
+64 3 3726700
Fax 104028 0
NA
Email 104028 0
caroline.bell@otago.ac.nz

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8565Study protocol  caroline.bell@otago.ac.nz 380242-(Uploaded-18-08-2020-14-04-57)-Study-related document.docx



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePsychosocial impacts on the Christchurch Muslim community following the 15 March terrorist attacks: A mixed-methods study protocol.2021https://dx.doi.org/10.1136/bmjopen-2021-055413
N.B. These documents automatically identified may not have been verified by the study sponsor.