Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000974909
Ethics application status
Approved
Date submitted
22/06/2020
Date registered
29/09/2020
Date last updated
29/09/2020
Date data sharing statement initially provided
29/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving wellbeing in high-stress high meaning work: insights from an online intervention to improve Aid Worker mental health
Scientific title
Improving wellbeing in high-stress, high-meaning work: radomised control trial of an online Acceptance and Commitment Therapy intervention designed to increase wellbeing, resilience and meaning and decrease depression, stress and anxiety in Aid Workers during a global pandemic.
Secondary ID [1] 301550 0
Nil known
Universal Trial Number (UTN)
U1111-1253-7580
Trial acronym
AWARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 317913 0
Wellbeing 317914 0
Stress 317915 0
Anxiety 317916 0
Condition category
Condition code
Mental Health 315953 315953 0 0
Depression
Mental Health 315954 315954 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Aid Worker Wellbeing and Resilience Program (AWARE) programme aims to increase aid worker wellbeing and decrease psychological distress. The intervention is based on Acceptance Commitment Therapy (ACT) which applies mindfulness and acceptance processes along with commitment and behaviour change to create psychological flexibility - the capacity to act in a manner that is aligned with personal values in the presence of challenging thoughts, emotions, and sensations. ACT has six key processes which foster psychological flexibility: contact with the present moment (mindfulness), acceptance (of internal experiences such as distress), cognitive defusion (being aware of a thought without acting on its content), self as context (flexible perspective taking), values, and committed action (in line with values). In our previous research we found that all 6 ACT factors are associated with higher wellbeing in aid workers.
Our intervention will deleiver ACT online with four modules covering the six ACT processes:
-Module 1: Values & Committed Action
-Module 2: Defusion
-Module 3: Acceptance
-Module 4: Mindfulness

Each online module includes psychoeducation on the relevant factor, individual reflection, and experiential exercises. Home assignments build on information presented in the modules and include recorded exercises and skills practice such as guided meditations, acting on set goals, practicing informal mindfulness, and practicing the skills of willingness and defusion. Each time participants start a new module they will be asked to report how often they completed the exercises from the last module: ''How many times did you practice or engage in the home activities from the last module in the past week?''. This is the only way in which the activities will be assessed.

The program will be implemented as 4 x 30 minute sessions completed by participants on their own electronic device over 2 to 6 weeks. Modules will be in an online, animated format, and hosted on a University of Queensland website.

The experimental group will undertake the intervention while the control group will be wait listed. After 4 weeks the control group will be provided with access to the intervention.
Intervention code [1] 317852 0
Behaviour
Comparator / control treatment
The control group will be wait-listed and told that they will have access to the program after 4 weeks. At this point the control group will be provided with the same intervention
Control group
Active

Outcomes
Primary outcome [1] 324160 0
Depression as measured by the Depression Anxiety and Stress Scale Short Form (DASS 21) (Lovibond & Lovibond, 1995)
Timepoint [1] 324160 0
Baseline, upon intervention completion (4 to 6 weeks after commencement) and at a follow up (3 months after program completion)
Primary outcome [2] 324161 0
Wellbeing as measured by the Mental Health Continuum Short Form (MHC-SF) (Keyes, 2009)
Timepoint [2] 324161 0
Baseline, upon intervention completion (4 to 6 weeks after commencement) and at a follow up (3 months after program completion)
Primary outcome [3] 324446 0
Anxiety as measured by the Depression Anxiety and Stress Scale Short Form (DASS 21) (Lovibond & Lovibond, 1995)
Timepoint [3] 324446 0
Baseline, upon intervention completion (4 to 6 weeks after commencement) and at a follow up (3 months after program completion)
Secondary outcome [1] 383886 0
Stress as measured by the Depression Anxiety and Stress Scale Short Form (DASS 21) (Lovibond & Lovibond, 1995)
Timepoint [1] 383886 0
Baseline, upon intervention completion (4 to 6 weeks after commencement) and at a follow up (3 months after program completion)
Secondary outcome [2] 383887 0
Resilience as measured by the Connor-Davidson Resilience Scale (CD-RISC) (Connor & Davidson, 2003)
Timepoint [2] 383887 0
Baseline, upon intervention completion (4 to 6 weeks after commencement) and at a follow up (3 months after program completion)
Secondary outcome [3] 383888 0
Psychological Flexibility as measured by the Multidimensional Psychological Flexibility Inventory (MPFI) (Rolffs, Rogge, & Wilson, 2016)
Timepoint [3] 383888 0
Baseline, upon intervention completion (4 to 6 weeks after commencement) and at a follow up (3 months after program completion)
Secondary outcome [4] 383889 0
Meaning as measured by the Meaning in Life Questionnaire (MLQ) (Steger et al., 2006)
Timepoint [4] 383889 0
Baseline, upon intervention completion (4 to 6 weeks after commencement) and at a follow up (3 months after program completion)
Secondary outcome [5] 384681 0
Burnout as measured by the Maslach Burnout Inventory (MBI) (Maslach, Jackson, & Leiter, 1997)
Timepoint [5] 384681 0
Baseline, upon intervention completion (4 to 6 weeks after commencement) and at a follow up (3 months after program completion)

Eligibility
Key inclusion criteria
1. Participants will have worked or volunteered in the aid sector for a minimum of 3 months.
2. Participants will be screened for age (must be above 18 years)
3. Participants will feel comfortable undertaking the project in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who work in related fields of peacekeeping, military operations, and diplomacy will be excluded from this study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Effects of attrition will be investigated through Little’s MCAR test. The effects of the program will be tested using ANOVAS and t-tests with each outcome scale to identify significant changes from pre to post-intervention to follow up. Mediational hypotheses will be investigated using parallel mediation analysis using model 4 of the PROCESS macro for SPSS (A. F. Hayes, 2012). Scores on resilience, meaning and psychological flexibility will be examined as potential mediators of change on each of the significant mental health outcomes.

Qualitative data will be analysed using thematic analysis (Braun & Clarke, 2006). The AWARE intervention will be updated following feedback from the pilot study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 22689 0
United Kingdom
State/province [1] 22689 0
Country [2] 22690 0
United States of America
State/province [2] 22690 0
Country [3] 22691 0
Nepal
State/province [3] 22691 0

Funding & Sponsors
Funding source category [1] 305986 0
University
Name [1] 305986 0
The University of Queensland
Country [1] 305986 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia, Brisbane, QLD, 4107
Country
Australia
Secondary sponsor category [1] 306480 0
None
Name [1] 306480 0
Address [1] 306480 0
Country [1] 306480 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306225 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 306225 0
Ethics committee country [1] 306225 0
Australia
Date submitted for ethics approval [1] 306225 0
11/12/2019
Approval date [1] 306225 0
16/12/2019
Ethics approval number [1] 306225 0
2019002942

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

Contacts
Principal investigator
Name 103158 0
Ms Tarli Young
Address 103158 0
School of Psychology, The University of Queensland, St Lucia, Brisbane, QLD, 4107
Country 103158 0
Australia
Phone 103158 0
+61 0468853232
Fax 103158 0
Email 103158 0
[email protected]
Contact person for public queries
Name 103159 0
Tarli Young
Address 103159 0
School of Psychology, The University of Queensland, St Lucia, Brisbane, QLD, 4107
Country 103159 0
Australia
Phone 103159 0
+61 0468853232
Fax 103159 0
Email 103159 0
[email protected]
Contact person for scientific queries
Name 103160 0
Tarli Young
Address 103160 0
School of Psychology, The University of Queensland, St Lucia, Brisbane, QLD, 4107
Country 103160 0
Australia
Phone 103160 0
+61 0468853232
Fax 103160 0
Email 103160 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
For IPD meta-analyses,
How or where can data be obtained?
https://osf.io/q4j5r/files/

These files are not yet public but will become public immediately following publication


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.