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Trial registered on ANZCTR


Registration number
ACTRN12618001578291
Ethics application status
Approved
Date submitted
31/08/2018
Date registered
24/09/2018
Date last updated
21/06/2021
Date data sharing statement initially provided
30/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating an attention training to reduce and prevent symptoms of posttraumatic stress in Australian military personnel returning to civilian life
Scientific title
Evaluating the effectiveness of attention control training to reduce and prevent PTSD symptomatology in transitioning Australian military personnel
Secondary ID [1] 293333 0
None
Universal Trial Number (UTN)
U1111-1213-9315
Trial acronym
SOAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Traumatic Stress Disorder 305424 0
Condition category
Condition code
Mental Health 304703 304703 0 0
Other mental health disorders
Mental Health 304704 304704 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Attention control training (ACT)

In ACT, participants perform four computer-delivered attention training sessions, 7 minutes per training session, over four weeks. Participants are required to attend in-person to the designated local office for the SOAR trial to complete the task on a laptop computer. The expectation is that participants complete one session a week for four weeks, although some flexibility will be allowed based on other time commitments associated with transitioning from the military. In each session the dot-probe task is administered. The task consists of 160 trials. Each trial begins with a centrally-presented fixation cross that is then replaced by a pair of neutral and threat words. A target probe appears in the location previously occupied by one of the words, and participants are requested to discriminate the probe type via button press. Targets appear with equal probability at the location of threat and neutral stimuli, in order to modify the fluctuations in attention allocation. Adherence to the intervention and instructions provided will be monitored using response time and accuracy rates; cases with extreme outliers will be excluded from analysis.
Intervention code [1] 299589 0
Prevention
Comparator / control treatment
Comparison task

In the comparison task, participants perform four computer-delivered attention training sessions, 7 minutes per training session, over four weeks. In each session the dot-probe task is administered. The task consists of 160 trials. Each trial begins with a centrally-presented fixation cross that then replaced by a pair of neutral - neutral words. A target probe then appears in the location previously occupied by one of the words, and participants are requested to discriminate the probe type via button press. This comparator task is presumably inactive.
Control group
Active

Outcomes
Primary outcome [1] 303917 0
Diagnosis of PTSD symptoms as measured by the PTSD Checklist (PCL-5). The PCL-5 is a 20-item self-report scale with scores ranging from 0 to 80, with higher scores reflecting more symptoms of PTSD. A proposed cut-off of >33 is indicative of probable PTSD (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013).
Timepoint [1] 303917 0
Pre-intervention, post-intervention (4 weeks), at 3 month follow-up (primary timepoint), and 12 month follow-up.
Primary outcome [2] 307408 0
PTSD symptom severity as measured by the PTSD Checklist (PCL-5). The PCL-5 is a 20-item self-report scale with scores ranging from 0 to 80, with higher scores reflecting more symptoms of PTSD (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013)..
Timepoint [2] 307408 0
Pre-intervention, post-intervention (4 weeks), at 3 month follow-up (primary timepoint), and 12 month follow-up.
Secondary outcome [1] 340456 0
Symptoms of depression as measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a nine item self-report questionnaire that measures depression severity. Items are rated from ‘0’ (not at all) to ‘3’ (nearly every day), with total scores ranging from 0-27.
Timepoint [1] 340456 0
Pre-intervention, post-intervention (4 weeks), at 3 month follow-up, and 12 month follow-up.
Secondary outcome [2] 351124 0
Symptom of anxiety as measured by the Generalized Anxiety Disorder (GAD-7). The GAD-7 is a seven item self-report questionnaire that measures anxiety severity, and is commonly used as a screening tool for generalized anxiety disorder (GAD). Items are rated from 0-3.
Timepoint [2] 351124 0
Pre-intervention, post-intervention (4 weeks), at 3 month follow-up, and 12 month follow-up
Secondary outcome [3] 351125 0
Functional impairment as measured by the Work and Social Adjustment Scale (WSAS).
The WSAS (Mundt, Marks, Shear, & Greist, 2002) is a 5 item measure that captures functional impairment across the domains of ‘work’, ‘home management’, ‘social leisure activities’, ‘private leisure activities’ and ‘family and relationships’. Participants are required to rate on a scale of 0 (not at all) and 8 (very severely) how much their problems interfere with each domain.
Timepoint [3] 351125 0
Pre-intervention, post-intervention (4 weeks), at 3 month follow-up, and 12 month follow-up

Eligibility
Key inclusion criteria
1. Must be 18 years of age or older
2. Must be a current serving member of the full-time ADF
3. Must be separating from the full-time ADF in the next 12 weeks
4. Must be able to commit to and complete the intervention before separation from ADF
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Report current self-identified treatment for bipolar or a psychotic disorder (due to the potential influences of medication and psychological symptoms on cognition)
2. Currently receiving medical treatment that may significantly impair their reaction times
3. Unable to use a computer keyboard

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be used for this trial. Specifically, a central randomisation website will be utilised across sites that assigns a participant to either condition 1 or 2, where neither participants nor administering research assistants will know which is the intervention and which the control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation), with stratification by trial site
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on an expected PTSD incidence rate of 20% in the control group and 15% in the treatment group, a total sample size of 1806 participant is required to detect a minimally important difference of 5% in PTSD rates at 3-months post-intervention, assuming 80% power and an alpha of 0.05.

Descriptive statistics will be used to summarise characteristics of intervention and control conditions, with regards to baseline characteristics and patterns of change over time. Differences between intervention and control conditions, on both primary and secondary outcomes, will be evaluated in a regression-based framework and in accordance with intention-to-treat (ITT) principles.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/10/2018
Actual
6/03/2019
Date of last participant enrolment
Anticipated
1/03/2021
Actual
26/03/2020
Date of last data collection
Anticipated
1/03/2022
Actual
Sample size
Target
1806
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 297957 0
Government body
Name [1] 297957 0
Veterans and Veterans' Families Counselling Service
Country [1] 297957 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
161 Barry St
Carlton (Melbourne)
VIC 3053
Country
Australia
Secondary sponsor category [1] 297020 0
Government body
Name [1] 297020 0
Veterans and Veterans' Families Counselling Service
Address [1] 297020 0
Veterans and Veterans Families Counselling Service (VVCS)
6-8 Campion St
Deakin (Canberra)
ACT 2600
Country [1] 297020 0
Australia
Other collaborator category [1] 280104 0
University
Name [1] 280104 0
Tel Aviv University
Address [1] 280104 0
School of Psychological Sciences and Sagol School of Neuroscience
Tel Aviv University
P.O. Box 39040
Tel Aviv
6997801
Country [1] 280104 0
Israel
Other collaborator category [2] 280321 0
Government body
Name [2] 280321 0
Australian Government Department of Defence
Address [2] 280321 0
PO Box 7911
Canberra BC ACT 2610
Country [2] 280321 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298999 0
The Departments of Defence and Veterans’ Affairs Human Research Ethics Committee (DDVA HREC)
Ethics committee address [1] 298999 0
Ethics committee country [1] 298999 0
Australia
Date submitted for ethics approval [1] 298999 0
01/03/2018
Approval date [1] 298999 0
06/06/2018
Ethics approval number [1] 298999 0
040-18

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

Contacts
Principal investigator
Name 78950 0
Prof Meaghan O'Donnell
Address 78950 0
Director of Research
Phoenix Australia
University of Melbourne
Level 3 Alan Gilbert Building
161 Barry St
Carlton
VIC 3053

Country 78950 0
Australia
Phone 78950 0
+61, 03, 9035 7883
Fax 78950 0
Email 78950 0
mod@unimelb.edu.au
Contact person for public queries
Name 78951 0
Tracey Varker
Address 78951 0
Phoenix Australia
University of Melbourne
Level 3 Alan Gilbert Building
161 Barry St
Carlton
VIC 3053
Country 78951 0
Australia
Phone 78951 0
+61, 03, 9035 7586
Fax 78951 0
Email 78951 0
tvarker@unimelb.edu.au
Contact person for scientific queries
Name 78952 0
Tracey Varker
Address 78952 0
Phoenix Australia
University of Melbourne
Level 3 Alan Gilbert Building
161 Barry St
Carlton
VIC 3053
Country 78952 0
Australia
Phone 78952 0
+61, 03, 9035 7586
Fax 78952 0
Email 78952 0
tvarker@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethical approval to share individual participant data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4418Study protocol  tvarker@unimelb.edu.au
4419Statistical analysis plan  tvarker@unimelb.edu.au



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.