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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

11/10/2023

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]

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

anxiety

PTSD

Psychological distress

Post traumatic growth

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Mental Health

Anxiety

Mental Health

Depression

Mental Health

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 5-7 years post the attacks.
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]

Early Detection / Screening

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Prevalence in the cohort of PTSD from the MINI diagnostic interview.

Timepoint [1]

First assessment 1-2 years, and subsequent at 4-5 years post Mosque attacks

Primary outcome [2]

Prevalence in the cohort of major depression from the MINI diagnostic interview.

Timepoint [2]

First assessment 1-2 years, and subsequent assessment 4-5 years post Mosque attacks.

Primary outcome [3]

Prevalence in the cohort of generalised anxiety disorder from the MINI diagnostic interview.

Timepoint [3]

First assessment at 1-2 years and subsequent assessment at 4-5 year post Mosque attacks.

Secondary outcome [1]

Prevalence in the cohort of panic disorder from the MINI diagnostic interview.
Primary outcome

Timepoint [1]

First assessment at 1-2 years and subsequent assessment at 4-5 years post Mosque attacks
Primary outcome

Secondary outcome [2]

Prevalence in the cohort of social phobia from the MINI diagnostic interview.
Primary outcome

Timepoint [2]

First assessment at 1-2 years and subsequent assessment at 4-5 years post Mosque attacks

Secondary outcome [3]

Prevalence in the cohort of agoraphobia from the MINI diagnostic interview.
Primary outcome

Timepoint [3]

First assessment at t 1-2 years and subsequent assessment at 4-5 years post Mosque attacks
Primary outcome

Secondary outcome [4]

Prevalence in the cohort of OCD from the MINI diagnostic interview.
Primary outcome

Timepoint [4]

First assessment at 1-2 years and subsequent assessment at 4-5 years post Mosque attacks.

Secondary outcome [5]

Prevalence in the cohort of bipolar disorder from the MINI diagnostic interview.
Primary outcome

Timepoint [5]

First assessment at 1-2 years and subsequent assessment at 4-5 years post Mosque attacks.

Secondary outcome [6]

Prevalence in the cohort of psychotic disorder from the MINI diagnostic interview.
Primary outcome

Timepoint [6]

First assessment at 1-2 years and subsequent assessment at 4-5 years post Mosque attacks.

Secondary outcome [7]

Prevalence in the cohort of substance use disorder from the MINI diagnostic interview.
Primary outcome

Timepoint [7]

First assessment at 1-2 years and subsequent assessment at 4-5 years post Mosque attacks.

Secondary outcome [8]

Number of attendances for health contact from participants unique NHI (National Health Index) records.

Timepoint [8]

For the 5 years before and after the attacks

Secondary outcome [9]

Measure of wellbeing - WHO5 Wellbeing Index

Timepoint [9]

First assessment at 1-2 years and subsequent assessment at 4-5 years post Mosque attacks.

Secondary outcome [10]

Measure of psychological distress- Kessler 10

Timepoint [10]

First assessment at 1-2 years and subsequent assessment at 4-5 years post Mosque attacks.

Secondary outcome [11]

Measure of PTSD - Post-traumatic Checklist for DSM5 - PCL5

Timepoint [11]

First assessment at 1-2 years and subsequent assessment at 4-5 years post Mosque attacks.

Secondary outcome [12]

Measure of somatic symptoms - Somatic Symptom Scale

Timepoint [12]

First assessment at 1-2 years and subsequent assessment at 4-5 years post Mosque attacks.

Secondary outcome [13]

Measure of functioning - Work and Social Adjustment Scale - WSAS

Timepoint [13]

First assessment at 1-2 years and subsequent assessment at 4-5 years post Mosque attacks.

Secondary outcome [14]

Measure of quality of life - Personal Wellbeing Index

Timepoint [14]

First assessment at 1-2 years and subsequent assessment at 4-5 years post Mosque attacks.

Secondary outcome [15]

Measure of post-traumatic growth - Post-traumatic Growth Inventory - PTGI

Timepoint [15]

First assessment at 1-2 years and subsequent assessment at 4-5 years post Mosque attacks.

Secondary outcome [16]

Measure of impact of Covid-19- Covid Impacts Scale

Timepoint [16]

First assessment at 1-2 years and subsequent assessment at 4-5 years post Mosque attacks.

Secondary outcome [17]

Measure of suicidality from MINI

Timepoint [17]

First assessment at 1-2 years and subsequent assessment at 4-5 years post Mosque attacks.

Secondary outcome [18]

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]

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

24/08/2026

Actual

Date of last data collection

Anticipated

24/08/2026

Actual

Sample size

Target

800

Accrual to date

190

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council of New Zealand

Address [1]

PO Box 5541, Victoria Street West, Auckland 1142

Country [1]

New Zealand

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Canterbury Research Medical Foundation

Address [2]

Level 1/230 Antigua Street,
Christchurch Central City,
Christchurch 8011

Country [2]

New Zealand

Funding source category [3]

University

Name [3]

University of Otago Research Grant

Address [3]

362 Leith Street,
Dunedin North,
Dunedin 9016

Country [3]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

New Zealand Health and Disability Ethics Committees

Ethics committee address [1]

Northern A Health and Disability Ethics Committees
Ministry of Health 133 Molesworth Street PO Box 5013 Wellington 6011
New Zealand

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

30/04/2020

Approval date [1]

01/07/2020

Ethics approval number [1]

19/NTA/147

Summary

Brief summary

On Friday 15 March 2019, approximately 300 people in two Mosques in Christchurch were attacked by a white supremacist shooter resulting in 71 being injured, 51 being shot dead. This study aims to explore the psychological effects of this event, in particular the impacts on those highly exposed - the bereaved, the injured, the witnesses and their adult family members. Assessments will be performed 1-2 years, and 4-5 years (and post the event) by Muslim researchers supported by a mental health nurse and include self-report measures and a diagnostic interview.
The aims are to a) understand the psychological, cultural and social effects of mass trauma in a Muslim community; b) To examine the value of clinical screening following such an event in detecting serious mental health difficulties.

Trial website

https://www.otago.ac.nz/march/index.html

Trial related presentations / publications

Nil

Public notes

Nil

Contacts

Principal investigator

Name

A/Prof Caroline Bell

Address

Department of Psychological Medicine
University of Otago Christchurch
PO Box 4345
Christchurch
8140

Country

New Zealand

Phone

+64 3 3726700

Fax

[email protected]

Contact person for public queries

Name

A/Prof Caroline Bell

Address

Department of Psychological Medicine
University of Otago Christchurch
PO Box 4345
Christchurch
8140

Country

New Zealand

Phone

+64 3 3726700

Fax

[email protected]

Contact person for scientific queries

Name

A/Prof Caroline Bell

Address

Department of Psychological Medicine
University of Otago Christchurch
PO Box 4345
Christchurch
8140

Country

New Zealand

Phone

+64 3 3726700

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Confidentiality of sensitive participant information

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8565	Study protocol			[email protected]		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

Source	Title	Year of Publication	DOI
Embase	Psychosocial impacts on the Christchurch Muslim community following the 15 March terrorist attacks: A mixed-methods study protocol.	2021	https://dx.doi.org/10.1136/bmjopen-2021-055413

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically