Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622001104741
Ethics application status
Approved
Date submitted
5/08/2022
Date registered
10/08/2022
Date last updated
23/05/2023
Date data sharing statement initially provided
10/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Well-Ahead Study: An intervention to optimise the wellbeing of female ex-serving military and former emergency services members
Scientific title
Well-Ahead feasibility study: Effect of the Skills fOr Life Adjustment and Resilience (SOLAR) program on psychological wellbeing in female ex-serving military and former emergency services members
Secondary ID [1] 307638 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 327133 0
Posttraumatic stress disorder (PTSD) symptoms 327135 0
Depressive symptoms 327136 0
Resilience 327138 0
Condition category
Condition code
Mental Health 324271 324271 0 0
Depression
Mental Health 324423 324423 0 0
Anxiety
Mental Health 324424 324424 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Skills fOr Life Adjustment and Resilience (SOLAR) is a brief, low intensity, psychosocial skills-based program developed as an early intervention strategy to prevent mild to moderate symptoms of psychological distress from developing into longer term psychological disorders. The adaptation of SOLAR for female ex-serving military and former emergency services members, will be delivered via a smartphone app. Participants will be expected to progress through the app at their own pace across five weeks, which includes psychoeducation (e.g., healthy diet), behavioural strategies (e.g., breathing exercises), and personalised goal setting via short videos and interactive activities. The intervention includes five modules (15 – 45 minutes each) on the following topics:
• Healthy body and mind
• Managing strong emotions
• Coming to terms with difficult experiences and related troubling events
• Improving range and quality of activities
• Worry and rumination
The app intervention will be supplemented by Facilitators. Upon commencement with the app, participants will be required to select a suitable time for their first Facilitator call. Facilitator calls will take between 5-15 minutes and will be offered weekly for the 5-week duration of the app, however, following the initial call, they are non-compulsory. Aside from facilitator calls and an email to the project team notifying completion of all modules, app adherence is not monitored. Facilitator support will include helping with technical aspects of progressing through the app and checking how participants are progressing with the in-app skill-building activities.
Participants will be prompted to complete 10–25-minute surveys regarding their psychological symptoms prior to commencement of the app, immediately following completion, and then another three months later.
Intervention code [1] 324144 0
Behaviour
Intervention code [2] 324145 0
Treatment: Other
Intervention code [3] 324202 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332174 0
Posttraumatic stress symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5)
Timepoint [1] 332174 0
Immediately pre-treatment, immediately post-treatment (primary endpoint, marked by completion of all modules in the app), and 3-months post treatment (i.e. 3 months post completion of all modules in the app).
Primary outcome [2] 332224 0
Psychological distress as measured by the Kessler Psychological Distress Scale (K10)
Timepoint [2] 332224 0
Immediately pre-treatment, immediately post-treatment (primary endpoint, marked by completion of all modules in the app), and 3-months post treatment (i.e. 3 months post completion of all modules in the app).
Primary outcome [3] 332225 0
Depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [3] 332225 0
Immediately pre-treatment, immediately post-treatment (primary endpoint, marked by completion of all modules in the app), and 3-months post treatment (i.e. 3 months post completion of all modules in the app).
Secondary outcome [1] 412476 0
Symptoms of anger as measured by the Dimensions of Anger Reactions Scale-5 (DAR-5)
Timepoint [1] 412476 0
Immediately pre-treatment, immediately post-treatment (marked by completion of all modules in the app), and 3-months post treatment (i.e. 3 months post completion of all modules in the app).
Secondary outcome [2] 412477 0
Quality of important social relationships as measured by the Schuster Social Support scale
Timepoint [2] 412477 0
Immediately pre-treatment, immediately post-treatment (marked by completion of all modules in the app), and 3-months post treatment (i.e. 3 months post completion of all modules in the app).
Secondary outcome [3] 412478 0
Functional impairment as measured by the Sheehan Disability Scale for Women
Timepoint [3] 412478 0
Immediately pre-treatment, immediately post-treatment (marked by completion of all modules in the app), and 3-months post treatment (i.e. 3 months post completion of all modules in the app).
Secondary outcome [4] 412479 0
Physical activity as measured by the International Physical Activity Questionnaire short form (IPAQ)
Timepoint [4] 412479 0
Immediately pre-treatment, immediately post-treatment (marked by completion of all modules in the app), and 3-months post treatment (i.e. 3 months post completion of all modules in the app).
Secondary outcome [5] 412480 0
Functional impairment as measured by the World Health Organisation Disability Assessment Schedule (WHODAS) short form
Timepoint [5] 412480 0
Immediately pre-treatment, immediately post-treatment (marked by completion of all modules in the app), and 3-months post treatment (i.e. 3 months post completion of all modules in the app).
Secondary outcome [6] 412671 0
Feasibility is assessed via completion rate as determined by automatic email to the project team notifying all modules have been completed.
Timepoint [6] 412671 0
Cumulative data will be assessed at the conclusion of the study

Eligibility
Key inclusion criteria
1. Ex-serving military or former emergency services member
2. Identify as female
3. Existing engagement with a health professional for individuals scoring in the probable disorder range of the PCL-C (equal to or greater than 53) or PHQ-9 (equal to or greater than 14)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Not at risk of self-harm or suicide
2. Not significantly impaired according to the WHODAS.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/04/2022
Date of last participant enrolment
Anticipated
16/09/2022
Actual
29/10/2022
Date of last data collection
Anticipated
16/12/2022
Actual
5/12/2022
Sample size
Target
40
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311902 0
Government body
Name [1] 311902 0
The Department of Premier and Cabinet Victoria
Country [1] 311902 0
Australia
Primary sponsor type
University
Name
Phoenix Australia - The University of Melbourne
Address
Level 3, 161 Barry Street
Carlton Victoria 3053
Country
Australia
Secondary sponsor category [1] 313382 0
None
Name [1] 313382 0
Address [1] 313382 0
Country [1] 313382 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311338 0
The Departments of Defence and Veterans' Affairs Human Research Ethics Committee
Ethics committee address [1] 311338 0
Ethics committee country [1] 311338 0
Australia
Date submitted for ethics approval [1] 311338 0
29/04/2021
Approval date [1] 311338 0
10/08/2021
Ethics approval number [1] 311338 0
357-21

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

Contacts
Principal investigator
Name 120762 0
A/Prof Lisa Dell
Address 120762 0
Phoenix Australia
Level 3, Alan Gilbert Building
161 Barry Street, Carlton
VIC 3053
Country 120762 0
Australia
Phone 120762 0
+61 3 9035 5599
Fax 120762 0
Email 120762 0
[email protected]
Contact person for public queries
Name 120763 0
Lisa Dell
Address 120763 0
Phoenix Australia
The University of Melbourne
Level 3, Alan Gilbert Building
161 Barry Street, Carlton
VIC 3053
Country 120763 0
Australia
Phone 120763 0
+61 3 9035 5599
Fax 120763 0
Email 120763 0
[email protected]
Contact person for scientific queries
Name 120764 0
Lisa Dell
Address 120764 0
Phoenix Australia
The University of Melbourne
Level 3, Alan Gilbert Building
161 Barry Street, Carlton
VIC 3053
Country 120764 0
Australia
Phone 120764 0
+61 3 9035 5599
Fax 120764 0
Email 120764 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
No IPD will be publicly available due to ethical constraints regarding participant privacy and consent


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.