Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000733572
Ethics application status
Approved
Date submitted
20/05/2024
Date registered
14/06/2024
Date last updated
14/06/2024
Date data sharing statement initially provided
14/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Not just a walk in the park: Implementing nature walking groups in rural mental health services as a transdiagnostic approach on mental health recovery.
Scientific title
Effect of implementing nature walking groups in rural mental health services for people with serious mental illness.
Secondary ID [1] 312183 0
Nil known
Universal Trial Number (UTN)
Trial acronym
NWG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health condition 333840 0
Condition category
Condition code
Mental Health 330518 330518 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of four Nature Walking Groups (NWGs) with 10 participants in each group will be conducted in the two sites over 12 months by the trained Nature Walking Group facilitators. Intervention participants (Group A; n=40) will participate in one NWG, receiving 1 hour per week in nature for a continuous period of 12 weeks (twelve walks per participant), while still also receiving treatment as usual (TAU). Participants can only join one walking group and the first 10 people to register interest and pass the screening assessment will be included. On each walk facilitators will draw participant attention to one of the natural features and guide participants through stress reduction and mindfulness activities, lasting 3 to 10 minutes in duration. Attendance checklists and observations conducted by a research assistant will monitor participation in the group and various routines.
A sample routine that will be used is -
Five Finger Breathing
Routine Summary: This breathing technique encourages you to use your fingers to take five deep breaths. This helps to process big emotions, connect to the present moment and feel more relaxed and comfortable. This breathing technique allows you to pause and use your fingers to take five deep breaths to help you to relax.
Where to use it: In a location where users can sit in a relaxing location and away from busy and noisy areas.
How will it make you feel: Practicing slow breathing techniques reduces symptoms of anxiety and stress by increasing feelings of calm, relaxation and alertness and enhancing sleep quality. Using your non-dominant hand creates new pathways in your brain, helping to improve your creativity and perspective on life.
Length: This activity takes between 2-3 minutes.
Script:
Step 1: Start by placing one hand on the earth (or in the air in front of you) and spread your fingers wide apart.
Step 2: Using your pointer finger from your other hand, slowly begin to trace up the outside of the thumb as you breathe in. Pause a little at the top of your thumb while holding your breath. Then trace down the inside of the thumb as you breathe out. Remember to pause again at the bottom.
Step 3: Repeat this for the remaining fingers, always making sure to breathe in as you trace up each finger and breathe out as you trace back down.
Repeat this breathing exercise as many times as you like - try for at least three cycles. Try tracing with your non-dominant hand - the one that you don’t usually write with.
Other routines are available from https://www.naturefix.life/
Intervention code [1] 328630 0
Behaviour
Intervention code [2] 328753 0
Treatment: Other
Comparator / control treatment
Treatment as usual (TAU) from the participating public mental health services. Individuals in Group B (control; n=40) will continue to receive TAU.
TAU consists of case management support and counselling based on individually determined goals of each person.
Control group
Active

Outcomes
Primary outcome [1] 338284 0
Change in anxiety and depression
Timepoint [1] 338284 0
baseline, 12 weeks (primary endpoint) and 3 months post 12-week collection.
Secondary outcome [1] 435288 0
Nature connection
Timepoint [1] 435288 0
baseline, 12 weeks and 3 months post 12 week collection
Secondary outcome [2] 435289 0
Personal wellbeing
Timepoint [2] 435289 0
baseline, 12 weeks and 3 months post 12 week collection
Secondary outcome [3] 435973 0
Stress
Timepoint [3] 435973 0
Baseline and 12 weeks (at end of NWG sessions)

Eligibility
Key inclusion criteria
• Currently receives mental health services at Illawarra Community Mental Health Service (ICMHS) or LikeMind
• Shows interest and commitment to be part of a 12-week program of weekly nature walking groups
• Completed and passed the health moves assessment
• Ability to walk unassisted for up to 60 minutes at low intensity
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Cannot participate in at least 10 of the 12 scheduled NWGs
• Instability in current mental health, for example, a current intent or plan of suicide

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To ensure a minimum detectable difference in the mean distress level between the intervention and control groups at follow-up, with a power of 80% and a 5% level of significance, a minimum sample size of 72 participants is required (36 participants in each group). Anticipating 10% loss to follow-up, we plan to include 80 participants in total. Therefore, data will be collected from at least 40 participants in both the control and intervention groups, enabling to assess the program's effectiveness in improving mental health outcomes. Our planned sample size falls within the range of suggested sample sizes for pilot and feasibility studies as per the guidelines, which recommend 30-59 participants (Billingham et al., 2013; Viechtbauer et al., 2015).
The outcomes will be analysed using a Wilcoxon signed ranks test to calculate change between scores because measures contain ordinal data and a test that does not assume a normal distribution is required. A W-statistic is appropriate for a small number of linked observations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/06/2024
Actual
Date of last participant enrolment
Anticipated
1/10/2024
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 42598 0
2800 - Orange
Recruitment postcode(s) [2] 42599 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 316553 0
Government body
Name [1] 316553 0
Department of Health and Aged Care (DoHAC), Australian Commonwealth Government.
Country [1] 316553 0
Australia
Primary sponsor type
University
Name
Rural Health Research Institute, Charles Sturt University
Address
Country
Australia
Secondary sponsor category [1] 318736 0
None
Name [1] 318736 0
Address [1] 318736 0
Country [1] 318736 0
Other collaborator category [1] 283074 0
University
Name [1] 283074 0
University of Wollongong
Address [1] 283074 0
Country [1] 283074 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315345 0
Charles Sturt University Human Research Ethics Committee
Ethics committee address [1] 315345 0
Ethics committee country [1] 315345 0
Australia
Date submitted for ethics approval [1] 315345 0
21/03/2024
Approval date [1] 315345 0
03/05/2024
Ethics approval number [1] 315345 0
H24047

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

Contacts
Principal investigator
Name 134406 0
A/Prof Julaine Allan
Address 134406 0
Charles Sturt University, Leeds parade, Orange, NSW, 2800
Country 134406 0
Australia
Phone 134406 0
+61 2 6365 7119
Fax 134406 0
Email 134406 0
[email protected]
Contact person for public queries
Name 134407 0
Julaine Allan
Address 134407 0
Charles Sturt University, Leeds parade, Orange, NSW, 2800
Country 134407 0
Australia
Phone 134407 0
+61 2 6365 7119
Fax 134407 0
Email 134407 0
[email protected]
Contact person for scientific queries
Name 134408 0
Julaine Allan
Address 134408 0
Charles Sturt University, Leeds parade, Orange, NSW, 2800
Country 134408 0
Australia
Phone 134408 0
+61 2 6365 7119
Fax 134408 0
Email 134408 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
Sample size is small and potentially identifiable.


What supporting documents are/will be available?




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.