Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000433606
Ethics application status
Approved
Date submitted
14/04/2023
Date registered
28/04/2023
Date last updated
21/04/2024
Date data sharing statement initially provided
28/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The LifeTrack Project: Understanding transitions between suicidal thoughts, suicidal behaviour, and remission from suicidality in an Australian community sample.
Scientific title
The LifeTrack Project: Population-based longitudinal cohort study to understand suicidal transitions
Secondary ID [1] 309448 0
National Health and Medical Research Council Grant ID GA259012
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidal behaviour 329699 0
Suicide attempt 329700 0
Condition category
Condition code
Mental Health 326600 326600 0 0
Suicide

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
LifeTrack is a quantitative observational cohort study of people who have recently experienced suicidal thoughts. The project aims to identify key risk and protective factors predicting the transition from suicidal ideation to suicide attempt and remission from suicidal ideation. It also aims to identify (a) distinct trajectories of suicidal ideation severity and the predictors of these trajectories and (b) subgroups most at risk of suicide attempts.

Australian resident adults who have recently experienced suicidal thoughts will complete a total of seven main surveys over three years (baseline and then every six months for three years). The surveys will measure constructs identified by three theoretical models of suicidality: the Interpersonal-Psychological Theory of Suicidal Behaviour, the Three-Step Theory, and Integrated Motivational-Volitional Theory.

After three of the main surveys (baseline, 12-month, and-24 month), participants will complete additional brief surveys each day for a week to measure short-term variability in key constructs (suicidal ideation, perceived burdensomeness, thwarted belongingness, acquired capability for suicide, and distress) .
Intervention code [1] 325873 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334450 0
Presence of a suicide attempt as determined by self- or confidante-report
Timepoint [1] 334450 0
Data will be acquired at baseline and at six-monthly intervals up to 36 months post-baseline.
Secondary outcome [1] 420745 0
Suicidal ideation as measured by the Suicidal Ideation Attributes Scale (SIDAS). Van Spijker, B. A., Batterham, P. J., Calear, A. L., Farrer, L., Christensen, H., Reynolds, J., & Kerkhof, A. J. (2014). The Suicidal Ideation Attributes Scale (SIDAS): Community-based validation study of a new scale for the measurement of suicidal ideation. Suicide and Life-Threatening Behavior, 44(4), 408-419.
Timepoint [1] 420745 0
Measurement will occur at baseline and at 6-monthly intervals for 36 months. Suicidal ideation will also be measured with one week of daily short surveys after three of the main surveys (baseline, 12 months, and 24 months).
Secondary outcome [2] 420746 0
Self harm ideation as measured by a single item from the Mental Health History Form (Boudewyn & Liem, 1995b as cited in Gratz, K. L. (2001). Measurement of deliberate self-harm: Preliminary data on the Deliberate Self-Harm Inventory. Journal of psychopathology and behavioral assessment, 23(4), 253. Doi: :0882-2689/01/1200-0253/0
Timepoint [2] 420746 0
Measurement will occur at baseline and at 6-monthly intervals for 36 months.
Secondary outcome [3] 420747 0
Self harm behaviour as measured by a single item from the Diagnostic Interview for Borderlines, Revised (Zanarini et al., 1989, as cited in McIntyre, J. C., Worsley, J., Corcoran, R., Harrison Woods, P., & Bentall, R. P. (2018). Academic and non-academic predictors of student psychological distress: The role of social identity and loneliness. Journal of Mental Health, 27(3), 230-239. https://doi.org/10.1080/09638237.2018.1437608
Timepoint [3] 420747 0
Measurement will occur at baseline and at 6-monthly intervals for 36 months.

Eligibility
Key inclusion criteria
Eligible participants are Australian residents who are fluent in English, aged 18 years or older, and have experienced suicidal thoughts in the past 30 days.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who have a recent suicide attempt (past 30 days), or who do not have the capacity to participate in a long-term study (self-reported).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We aim to recruit 842 participants based on the following calculations. Our power calculation is based on detection of the effect of our explanatory variables on transition from suicidal ideation to suicide attempt. We conservatively assume that at least 15% of the sample will attempt suicide at some stage during the follow-up period, based on research findings that up to 20% of people with suicidal ideation will attempt suicide over 12 months (Chan et al., 2014; May et al., 2012; van Spijker et al, 2018). We aim to have 90% power to detect a moderate standardised effect of d = 0.5 (i.e., effect size at least half a standard deviation from zero) between those who do vs do not attempt suicide, requiring a sample of N = 374. To allow detection of interactions between multiple modifiable factors and have sufficiently narrow confidence intervals around estimates of population preventable fractions (PPF), we have inflated the target sample size by 35% (equivalent to a four group comparison, rather than suicide attempt vs no suicide attempt). Further assuming up to 40% attrition at 36 months, we will recruit a sample of N = 842 participants (374 × 1.35 ÷ 0.6). This sample will also be powered to detect up to five latent classes using growth mixture models and latent class analysis to identify subgroups within the sample based on trajectories of SI or baseline characteristics and for machine learning analyses.

To identify factors most strongly associated with the transition from suicidal ideation to suicide attempt and recovery from suicidal ideation statistical analyses will include Cox proportional hazards regression models (time to suicide attempt) and zero-inflated negative binomial mixed models (number of suicide attempts) accounting for lifetime suicide attempt, with suicide deaths treated as right-censored data. Effects will be converted to PPFs based on estimated hazard ratios, combined with prevalence rates taken from external representative data where available or from the cohort. Growth mixture model analyses conducted using Mplus will classify subgroups of individuals based on their trajectories of suicidal ideation severity. We will test for both linear and quadratic trajectories (using continuous Suicidal Ideation Attributes Scale severity scores). Latent class analyses will differentiate subgroups of individuals reporting suicidal ideation at baseline. Multinomial logistic regression analyses will then identify factors associated with each of the identified trajectories or latent classes. We will also use machine learning algorithms to identify novel interactions between factors, using a random split-half (development-validation) approach to classify participants on the basis of suicide attempt and on remission from suicidal ideation.

Chan LF, et al. Psychiatry Res, 2014. 220: 867-73.
May AM, et al. J Psychiatr Res, 2012. 46: 946-52.
van Spijker BA, et al. J Med Internet Res, 2018. 20: e15.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/05/2023
Actual
16/07/2023
Date of last participant enrolment
Anticipated
30/11/2023
Actual
30/10/2023
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
842
Accrual to date
Final
925
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313646 0
Government body
Name [1] 313646 0
National Health and Medical Research Council (NHMRC)
Country [1] 313646 0
Australia
Primary sponsor type
Individual
Name
Philip Batterham
Address
Centre for Mental Health Research
Research School of Population Health
ANU College of Health and Medicine
63 Eggleston Road
The Australian National University
Acton ACT 2601 Australia
Country
Australia
Secondary sponsor category [1] 315437 0
None
Name [1] 315437 0
Address [1] 315437 0
Country [1] 315437 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312814 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 312814 0
Ethics committee country [1] 312814 0
Australia
Date submitted for ethics approval [1] 312814 0
19/12/2022
Approval date [1] 312814 0
05/04/2023
Ethics approval number [1] 312814 0
2022/851

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

Contacts
Principal investigator
Name 126010 0
Prof Philip Batterham
Address 126010 0
Centre for Mental Health Research
Research School of Population Health
ANU College of Health and Medicine
63 Eggleston Road
The Australian National University
Acton ACT 2601 Australia
Country 126010 0
Australia
Phone 126010 0
+61 2 61251031
Fax 126010 0
Email 126010 0
[email protected]
Contact person for public queries
Name 126011 0
Monica Gendi
Address 126011 0
Centre for Mental Health Research
Research School of Population Health
ANU College of Health and Medicine
63 Eggleston Road
The Australian National University
Acton ACT 2601 Australia
Country 126011 0
Australia
Phone 126011 0
+61 2 6125 0084
Fax 126011 0
Email 126011 0
[email protected]
Contact person for scientific queries
Name 126012 0
Monica Gendi
Address 126012 0
Centre for Mental Health Research
Research School of Population Health
ANU College of Health and Medicine
63 Eggleston Road
The Australian National University
Acton ACT 2601 Australia
Country 126012 0
Australia
Phone 126012 0
+61 2 6125 0084
Fax 126012 0
Email 126012 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
SourceTitleYear of PublicationDOI
EmbaseUnderstanding suicidal transitions in Australian adults: protocol for the LifeTrack prospective longitudinal cohort study.2023https://dx.doi.org/10.1186/s12888-023-05335-1
N.B. These documents automatically identified may not have been verified by the study sponsor.