Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001011673
Ethics application status
Approved
Date submitted
4/09/2023
Date registered
19/09/2023
Date last updated
19/09/2023
Date data sharing statement initially provided
19/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bee Well: Piloting a new mental health intervention for rural young people who have been exposed to a natural disaster
Scientific title
The acceptability, feasibility, and clinical utility of a novel mental health and resilience intervention targeting natural disaster-exposed rural youth
Secondary ID [1] 310412 0
None
Universal Trial Number (UTN)
U1111-1297-1191
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Climate change anxiety 331169 0
Condition category
Condition code
Mental Health 327940 327940 0 0
Anxiety
Mental Health 327941 327941 0 0
Depression
Mental Health 327942 327942 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a single day workshop, conducted face-to-face in a natural environment outdoors. The workshop will run for a duration of approximately 8 hours and each participant will only attend the workshop once. The intervention will be delivered in a group setting, with 10-12 participants receiving the intervention together. The workshop will be delivered by registered Clinical Psychologists and Provisional Psychologists (enrolled in the University of New England (UNE) Master of Clinical Psychology program). The intervention will be conducted through interactive activities. Elements of the workshop include mindfulness activities (guided meditation), group discussion about eco-emotions, a group restoration project (building a bee hive), and brainstorming self-care strategies (e.g. taking a break from climate news).
Intervention code [1] 326809 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335816 0
The presence and severity of anxiety related to climate change, as measured by the Climate Change Anxiety Scale (CCAS)
Timepoint [1] 335816 0
2-weeks prior to the intervention, and again immediately post-intervention, and at follow up 4-weeks post intervention
Primary outcome [2] 335817 0
The presence and severity of depression, as measured by the Depression, Anxiety and Stress Scale (DASS-21)
Timepoint [2] 335817 0
2-weeks prior to the intervention, and again immediately post-intervention, and at follow up 4-weeks post intervention
Primary outcome [3] 335818 0
Perceived ability to cope adaptively with stress/hardship, as measured by the Brief Resilience Scale and the Brief Resilient Coping Scale( BRCS)
Timepoint [3] 335818 0
2-weeks prior to the intervention, and again immediately post-intervention, and at follow up 4-weeks post intervention
Secondary outcome [1] 425783 0
Participant satisfaction, as assessed by Likert-scales and open-ended questions (designed specifically for the study)
Timepoint [1] 425783 0
Immediately post-intervention
Secondary outcome [2] 425784 0
Acceptability of the intervention, as assessed by Likert-scales and open-ended questions (designed specifically for the study)
Timepoint [2] 425784 0
Immediately post-intervention
Secondary outcome [3] 426252 0
The presence of symptoms of Adjustment Disorder, as measured by the Adjustment Disorder New Module 8 (ADMN-8)
Timepoint [3] 426252 0
2-weeks prior to the intervention, and again immediately post-intervention, and at follow up 4-weeks post intervention
Secondary outcome [4] 426253 0
Overall mood state (pleasant-unpleasant, calm-aroused), as measured by the Brief Mood Introspection Scale (BMIS)
Timepoint [4] 426253 0
Immediately pre-intervention, and then again immediately post-intervention
Secondary outcome [5] 426254 0
Subjective Distress related to natural disaster exposure, as measured on a scale 0-100 of Subjective Units of Distress (SUDS)
Timepoint [5] 426254 0
Immediately pre-intervention, and then again immediately post-intervention
Secondary outcome [6] 426255 0
The presence of any common psychiatric disorders, as indicated by the MINI International Neuropsychiatric Interview
Timepoint [6] 426255 0
2-weeks prior to the intervention, and again at follow up 4-weeks post intervention
Secondary outcome [7] 426665 0
The presence and severity of anxiety, as measured by the Depression, Anxiety and Stress Scale (DASS-21). THIS IS AN ADDITIONAL PRIMARY OUTCOME
Timepoint [7] 426665 0
2-weeks prior to the intervention, and again immediately post-intervention, and at follow up 4-weeks post intervention.
Secondary outcome [8] 426666 0
The presence and severity of stress symptoms, as measured by the Depression, Anxiety and Stress Scale (DASS-21). THIS IS AN ADDITIONAL PRIMARY OUTCOME
Timepoint [8] 426666 0
2-weeks prior to the intervention, and again immediately post-intervention, and at follow up 4-weeks post intervention. THIS IS AN ADDITIONAL PRIMARY OUTCOME

Eligibility
Key inclusion criteria
Eligibility to take part in the program will be any individual that is :
a) aged 16-18 years,
b) currently residing in rural NSW, with
c) self-reported lifetime exposure to any natural disaster (e.g., flood, fire, drought, or the 2021 supercell tornado).
Minimum age
16 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Ineligibility criteria are:
a) individuals who fail comprehension checks or
b) who have acute suicidal risk, psychosis, bipolar disorder, or as having a cognitive impairment/disability, are under the influence of a substance, or have any other significant impediment to participation - as ascertained by diagnostic interview (MINI) and/or clinical judgement as part of eligibility screening.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This project pilots an intervention, generally precluding definitive sample size calculation. It has been argued that, for clinical intervention pilots, a minimum of 10 persons completing in the intervention group is required. In order to allow for up to 40% attrition at 1 month follow-up, and ensure sufficient data for preliminary efficacy testing, a minimum sample of 24 is anticipated (Total N = 24 receiving intervention).

The intervention's efficacy and potential clinical utility to lead to meaningful change will be assessed by calculating the Reliable Change Index (RCI) for the continuous mental health questionnaire outcomes (i.e. DASS-21, CCAS).. Because the RCI is dependent on a tests’ re-test reliability coefficient, and there may not be enough participant variability in baseline scores to quantify reliable change, we will also assess mean change from pre-, post- and 1-month on continuous measures using general linear models with time as a fixed factor. In secondary analyses, we will assess changes in the cumulative number of disorders, quantified by the MINI, utilizing Poisson regression. The intervention’s acceptability will be assessed by quantifying mean acceptability scores for each component of the intervention.

Open-ended questions will be explored via conventional content analysis in order to ascertain (dis)preferred components of the intervention, as well as perceived helpfulness and acceptability of the program.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/09/2023
Date of last participant enrolment
Anticipated
29/09/2023
Actual
Date of last data collection
Anticipated
8/11/2023
Actual
Sample size
Target
24
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314620 0
Charities/Societies/Foundations
Name [1] 314620 0
The Peregrine Centre (Rural Mental Health Small Project Grants)
Country [1] 314620 0
Australia
Primary sponsor type
University
Name
University of New England
Address
Elm Avenue, Armidale, NSW 2350
Country
Australia
Secondary sponsor category [1] 316773 0
None
Name [1] 316773 0
Address [1] 316773 0
Country [1] 316773 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313643 0
Human Research Ethics Committee of the University of New England
Ethics committee address [1] 313643 0
Ethics committee country [1] 313643 0
Australia
Date submitted for ethics approval [1] 313643 0
24/05/2023
Approval date [1] 313643 0
29/08/2023
Ethics approval number [1] 313643 0

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

Contacts
Principal investigator
Name 128850 0
Dr Suzie Cosh
Address 128850 0
School of Psychology, University of New England, NSW, 2351
Country 128850 0
Australia
Phone 128850 0
+61267732073
Fax 128850 0
Email 128850 0
[email protected]
Contact person for public queries
Name 128851 0
Rosie Ryan
Address 128851 0
School of Psychology, University of New England, NSW, 2351
Country 128851 0
Australia
Phone 128851 0
+61267735508
Fax 128851 0
Email 128851 0
[email protected]
Contact person for scientific queries
Name 128852 0
Rosie Ryan
Address 128852 0
School of Psychology, University of New England, NSW, 2351
Country 128852 0
Australia
Phone 128852 0
+61267735508
Fax 128852 0
Email 128852 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
No additional documents have been identified.