Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000283875
Ethics application status
Approved
Date submitted
25/01/2021
Date registered
16/03/2021
Date last updated
5/05/2023
Date data sharing statement initially provided
16/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial comparing a brief wellbeing intervention delivered by coaches with a self-directed intervention to promote recovery in Victorian regional and rural communities impacted by bushfires, drought, and COVID-19.
Scientific title
Skills for Life Adjustment and Resilience (SOLAR): A randomised trial comparing a brief psychosocial intervention delivered by coaches with a self-directed intervention to reduce distress and promote recovery in Victorian regional and rural communities impacted by bushfires, drought, and COVID-19.
Secondary ID [1] 302992 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 320044 0
Depression 320045 0
Condition category
Condition code
Mental Health 317969 317969 0 0
Anxiety
Mental Health 317970 317970 0 0
Depression
Mental Health 317971 317971 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the SOLAR program will receive 5 face-to-face or telehealth sessions of the SOLAR program. The first session runs for 80 minutes and subsequent sessions for 50 minutes each. Sessions involve practical and skills-based one-on-one sessions with a trained “Coach”. The intervention will be delivered by trained “Coaches” who may be psychologists, social workers, community workers or teachers that are trained and provided with weekly supervision by Phoenix Australia. Participants will be allocated to a Coach within their workplace for face-to-face treatment or telehealth.

The SOLAR program comprises elements drawn from evidence based treatments for individuals experiencing mental health problems with behavioural skill development, psychoeducation, and cognitive strategies. Specifically, these elements include components on psychoeducation about healthy living, information about keeping relationships healthy, values based behavioural activation, arousal and affective management, emotional writing of the disaster experience, and dealing with worry and rumination. Session 1: Healthy lifestyle; physical activity and sleep, managing strong emotions with controlled breathing. Relaxing activities; Session 2: Diet, grounding exercises, expressive writing; Session 3: Healthy relationships, behavioural activation; Session 4: Dealing with worry and rumination; and Session 5: Reviewing achievements and planning for the future.

Following each session the participant will be encouraged to complete homework activities which includes the following: Session 1: 1 physical activity, 1 relaxing activity, practice controlled breathing, 1 good sleeping habit (1 – 2 hours); Session 2: 1 healthy diet change, 1 grounding exercise, writing their disaster story (1 – 2 hours); Session 3: Behavioural activation, complete 3 activities with others (1 – 2 hours); Session 4: practice a strategy for dealing with worry and rumination, behavioural activation, complete 3 new activities (1 – 2 hours); Session 5: None.

All Coaches will undergo training delivered by Phoenix Australia in both self-directed online learning and group based training via videoconferencing and will be provided with a Coach manual, Participant workbook and Training PowerPoint. During the training there will be didactic delivery of information, group discussion, demonstration videos and skill rehearsal via videoconferencing. Training will include 2.5 hours of self-directed online learning, 4 hours group based videoconferencing training, 2 hours optional group based videoconferencing counselling skills session for those without a background in counselling, and 2 hour preparation supervision session prior to intervention commencement, and 1 hour supervision sessions once intervention has commenced.

Strategies to monitor adherence to the intervention include evaluating coaches' knowledge and confidence pre- and post-training and rating level of competence across specified criteria when coaches engage in role plays during training (e.g., demonstrated rationale when explaining skill). As part of a SOLAR accreditation process, 1 session for each coach was recorded and provided to Phoenix Australia for fidelity monitoring purposes. SOLAR coaches will also engage in weekly supervision during the study period.
Intervention code [1] 319279 0
Treatment: Other
Intervention code [2] 319796 0
Behaviour
Comparator / control treatment
Participants randomised to the minimal intervention (termed ONLINE Program) will receive the less time intensive intervention involving self-help resources that will be emailed to participants every week for 5 weeks. The emails will contain publicly available resources (in the form of factsheets and links to websites) that have information about post-disaster mental health and strategies for managing reactions to trauma or severe stressors. Each email and review of the content linked in the brochure will take 15 to 20 minutes to read each week, with additional time needed to practice the skills contained in the resources.

The content for the emails includes (i) Psychoeducation about the emotional impact of disasters, healthy living and self-care, (ii) Managing emotions, (iii) Social support, (iv) Activity scheduling AND managing avoidance, (v) Problem solving and planning for the future/stay well. The emails have been designed specifically for this study with links to resources within Phoenix Australia’s website in the first instance and other organisations such as Mindspot. Participants completing the ONLINE program will be offered a place in the SOLAR Program after the 2 month follow-up assessment.
Control group
Active

Outcomes
Primary outcome [1] 325981 0
Psychological distress as measured by the HADS (Hospital Anxiety Depression Scale)
Timepoint [1] 325981 0
Immediately prior to treatment, post-treatment (2-weeks post-treatment), follow-up (2-month post treatment)
Secondary outcome [1] 389770 0
Posttraumatic stress symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5)
Timepoint [1] 389770 0
Immediately prior to treatment, post-treatment (2-weeks post-treatment), follow-up (2-month post treatment)
Secondary outcome [2] 389771 0
Dimensions of Anger Reactions Scale-5 (DAR-5)
Timepoint [2] 389771 0
Immediately prior to treatment, post-treatment (2-weeks post-treatment), follow-up (2-month post treatment)
Secondary outcome [3] 390371 0
Symptoms of insomnia as measured by the Insomnia Severity Index (ISI)
Timepoint [3] 390371 0
Immediately prior to treatment, post-treatment (2-weeks post-treatment), follow-up (2-month post treatment)
Secondary outcome [4] 390372 0
Alcohol and drug use as measured by the Substance use Recovery Evaluator (Part A only) - composite outcome
Timepoint [4] 390372 0
Immediately prior to treatment, post-treatment (2-weeks post-treatment), follow-up (2-month post treatment)
Secondary outcome [5] 390999 0
General psychological adjustment as measured by the Brief Adjustment Scale (BASE-6).
Timepoint [5] 390999 0
Immediately prior to treatment, post-treatment (2-weeks post-treatment), follow-up (2-month post treatment)

Eligibility
Key inclusion criteria
1. Adults aged 18 years and over and residing in a disaster affected rural or regional community, or who experienced a disaster in a rural or regional community, in Victoria and broader rural/regional Australia;
2.Have been substantially impacted by disasters including drought, bushfires, and/or COVID-19;
3. English comprehension sufficient to provide informed consent;
4. Elevated psychological distress, as measured by scores greater than or equal to 4 on the PHQ-9 or GAD-7 AND report functional impairment in daily life as a result of the distress symptoms;
5. Interest in taking part in a 5 week program involving either SOLAR or a minimal intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Report having a severe mental disorder or cognitive impairment (e.g., severe intellectual disability, dementia, psychosis, mania)
2. Are at risk of self-harm or suicide;
3. Scores “>19” on PHQ-9 or “>14” on GAD-7 AND wish to obtain more intensive psychological treatment from a mental health professional over the 5 week intervention period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will occur following the determination of eligibility by the intake officer and coordinated via the REDCap randomisation software by the clinical research assistant. Randomisation will be conducted according to a computer generated randomisation list provided by the blinded study statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size is based on a power analysis for a between-subjects ANCOVA for main effects and interaction, which compares post-test scores between groups while controlling for pre-test scores under the assumption of homogeneity of slopes and variances between groups. Within-subjects analyses of change is also planned.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/04/2021
Actual
23/04/2021
Date of last participant enrolment
Anticipated
Actual
24/10/2022
Date of last data collection
Anticipated
Actual
27/02/2023
Sample size
Target
80
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC

Funding & Sponsors
Funding source category [1] 307400 0
Charities/Societies/Foundations
Name [1] 307400 0
State Trustees Australia Foundation
Country [1] 307400 0
Australia
Funding source category [2] 313791 0
Government body
Name [2] 313791 0
Victorian Department of Health & Human Services.
Country [2] 313791 0
Australia
Primary sponsor type
University
Name
Phoenix Australia, Melbourne University
Address
Level 3, 161 Barry Street
Carlton Victoria 3053
Country
Australia
Secondary sponsor category [1] 308065 0
None
Name [1] 308065 0
Address [1] 308065 0
Country [1] 308065 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307486 0
Human Research Ethics Committee - Melbourne University
Ethics committee address [1] 307486 0
Ethics committee country [1] 307486 0
Australia
Date submitted for ethics approval [1] 307486 0
24/12/2020
Approval date [1] 307486 0
18/01/2021
Ethics approval number [1] 307486 0
2022-14453-29544-17

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

Contacts
Principal investigator
Name 107402 0
Prof Meaghan O'Donnell
Address 107402 0
Phoenix Australia, Centre for Posttraumatic Mental Health
Department of Psychiatry, The University of Melbourne
Level 3, Alan Gilbert Building, 161 Barry Street
Carlton Victoria 3053
Country 107402 0
Australia
Phone 107402 0
+61 3 9035 7883
Fax 107402 0
+61 3 9035 5455
Email 107402 0
[email protected]
Contact person for public queries
Name 107403 0
Sophie Alexander
Address 107403 0
Phoenix Australia, Centre for Posttraumatic Mental Health
Department of Psychiatry, The University of Melbourne
Level 3, Alan Gilbert Building, 161 Barry Street
Carlton Victoria 3053
Country 107403 0
Australia
Phone 107403 0
+61 3 9035 5599
Fax 107403 0
+61 3 9035 5455
Email 107403 0
[email protected]
Contact person for scientific queries
Name 107404 0
Meaghan O'Donnell
Address 107404 0
Phoenix Australia, Centre for Posttraumatic Mental Health
Department of Psychiatry, The University of Melbourne
Level 3, Alan Gilbert Building, 161 Barry Street
Carlton Victoria 3053
Country 107404 0
Australia
Phone 107404 0
+61 3 9035 5599
Fax 107404 0
+61 3 9035 5455
Email 107404 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
Results will be analysed at the treatment group data level, and any results from this trial that are published in scientific journals will publish group data only. Therefore individual, raw-line-by-line data will not be published for each participant.


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.