Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001183976
Ethics application status
Approved
Date submitted
8/09/2020
Date registered
9/11/2020
Date last updated
9/11/2020
Date data sharing statement initially provided
9/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Stepped Wedge Cluster Randomised Trial of Social Prescribing of Forest Therapy for Adults with Mental Illness
Scientific title
Stepped Wedge Cluster Randomised Trial of the Impact of Social Prescribing of Forest Therapy on Quality of Life for Adults with Mental Illness
Secondary ID [1] 302257 0
None
Universal Trial Number (UTN)
U1111-1258-0756
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 318974 0
Schizophrenia 318975 0
Psychosis and personality disorders 318976 0
Addiction 318977 0
Anxiety 318978 0
Eating disorders 318979 0
Other mental health disorders 318980 0
Condition category
Condition code
Mental Health 316944 316944 0 0
Addiction
Mental Health 316945 316945 0 0
Anxiety
Mental Health 316946 316946 0 0
Depression
Mental Health 316947 316947 0 0
Eating disorders
Mental Health 316948 316948 0 0
Other mental health disorders
Mental Health 316949 316949 0 0
Psychosis and personality disorders
Mental Health 316950 316950 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Forest Therapy (AKA Shinrin-Yoku "Forest Bathing").
Materials: Questionnaires, Omron HEM-7600T electronic blood pressure monitors.
Mode of delivery: Face-to-face.
Number of times: 10 weekly 1.5hr sessions.
Duration of each step: Duration of each step: A new group (‘cluster’) of participants (n=6-10) will commence every week at the first site (Gold Coast) until all participants (n=40) have completed the control and intervention (and follow-up) periods. After this data collection will commence at the second site (Sydney) where weekly clusters of participants will commence until all participants have completed the study.
Further clarification is as follows: Data collection will be completed at site 1 (Gold Coast) and then commence at site 2 (Sydney). At individual sites clusters will commence weekly, and the order of commencement will be randomised. This group commencement comprises the ‘wedge’ of the study (i.e. each cluster of participants is a wedge), and weekly commencement comprises the ‘stepped’ aspect of this design. Once commenced the cluster will complete a 10-week control period, and 15-week intervention (and follow-up).
Monitoring of adherence: The Forest Therapy Guide will complete a checklist of attendees at each session.
Procedures:
Each 1.5hr session will have the same structure:
• pre-walk data collection,
• introduction to Shinrin-Yoku/Forest Bathing,
• sensory tuning activity – designed to ground participants using a combination of breathing exercises and gentle physical movement activities,
• introduction to forest and local environment – overview of the physical space the walk will be conducted in, including important ecological, historical and cultural information,
• creative and sensory activities – each walk has a combination of creative and sensory based activities. These are designed to facilitate mindful activity in the forest environment through creative and sensory means, and include activities like:
o focusing on a specific nature point in the distance for a few minutes quietly,
o collecting fallen objects such as leaves, rock, etc and creating a collective artwork,
o creating a sound map of the area using paper/pens,
o exploring textures in the natural environment by safely touching trees, grass, etc.
• sit spot – this is an opportunity for participants to sit quietly and observe nature in a safe and calm environment,
• tea ceremony – prior to winding up the walk, participants will be invited to share a cup of tea and their favourite part of the experience,
• post-walk data collection.
Intervention clinical staff: Maximum ratio of 3 participants: 1 clinician, including:
Intervention Guide: Certified Forest Therapy Guide (International Nature and Forest Therapy Alliance-INFTA).
Other staff: Allied Health Workers/Mental Health Nurses.
Location: Baree Badalla Reserve, Gold Coast, and Kuringgai Wildflower Garden, Sydney.
Intervention code [1] 318543 0
Lifestyle
Intervention code [2] 318544 0
Behaviour
Comparator / control treatment
All participants will complete an initial 10-week wait-list control period prior to commencement of the intervention phase. During this control period they will receive standard care provided by PCCS; this comprises assessment of needs and linkage to appropriate services. These may include psychological care (referral to counsellor, psychologist, condition-specific support groups), medical assistance (medication management, OT referral), and welfare needs (assistance accessing the NDIS, access to food, housing, or employment services). This standard care will also continue throughout the intervention period (hence the importance of a control period in our study design).
Control group
Active

Outcomes
Primary outcome [1] 325055 0
Change in Quality of Life assessed using the World Health Organisation QoL (WHOQoL-Bref)
Timepoint [1] 325055 0
End of 10-week control period compared with end of 10-week intervention.
Secondary outcome [1] 386685 0
Change in depression symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9).

Timepoint [1] 386685 0
End of 10-week control period compared with end of 10-week intervention.
Secondary outcome [2] 386686 0
Change in anxiety symptoms assessed using the Generalised Anxiety Disorder Questionnaire (GAD-7).
Timepoint [2] 386686 0
End of 10-week control period compared with end of of 10-week intervention.
Secondary outcome [3] 386687 0
Change in work and social adjustment assessed using the Work and Social Adjustment Scale (WSAS).

Timepoint [3] 386687 0
End of 10-week control period compared with end of of 10-week intervention.
Secondary outcome [4] 386688 0
Change in Loneliness assessed using the UCLA 3-item Loneliness Scale.
Timepoint [4] 386688 0
End of 10-week control period compared with end of of 10-week intervention.
Secondary outcome [5] 386689 0
Change in Health Self-efficacy asses using the The Health Confidence Score (HCS)
Timepoint [5] 386689 0
End of 10-week control period compared with end of of 10-week intervention.
Secondary outcome [6] 386690 0
Any change in health service utilisation. This will be assessed using participant self-report of the following activities over the past 4 weeks: number of times an ambulance was called, hospital (ED) visits, hospital admissions, nights spent in hospital, GP visits, allied health visits, and number of times community health services were accessed.
Timepoint [6] 386690 0
End of 10-week control period compared with end of of 10-week intervention.
Secondary outcome [7] 386691 0
Any change in mood assessed using the Profile of Mood States-Adolescents (POMS-A)
Timepoint [7] 386691 0
Start and end of each intervention session.
Secondary outcome [8] 386692 0
Change in Pulse Rate assessed using the Omron HEM-7600T electronic upper-arm blood pressure and pulse rate monitor.
Timepoint [8] 386692 0
Start and end of each intervention session.
Secondary outcome [9] 386693 0
Qualitative Interviews
Semi-structured interviews will be conducted over the phone, one-on-one, and will be audiotaped and transcribed. Interviews will investigate participants’ experiences of the Forest Therapy intervention and any impacts on their lives during and after the intervention; this will include aspects of intervention they believe were most enjoyable and beneficial, and any ways they feel it could be improved.
Timepoint [9] 386693 0
5-weeks post completion of the 10-week intervention.
Secondary outcome [10] 387734 0
Change in Blood Pressure assessed using the Omron HEM-7600T electronic upper-arm blood pressure and pulse rate monitor.
Timepoint [10] 387734 0
Start and end of each intervention session.

Eligibility
Key inclusion criteria
1. Adult (aged 18+ years),
2. any sex i.e. male, female, or non-specified,
3. diagnosed with a mental illness (mood or psychotic disorder),
4. able to complete study questionnaires in English, and
5. capable of providing informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Receiving inpatient care,
2. thoughts of harm to self or others, or
3. cognitive deficit which prevents capacity to provide informed consent or to complete study questionnaires.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Stepped wedge cluster randomised trial design. Each participant has a ‘wait-list control’ period and then is exposed to the intervention. Participants commence the intervention in ‘clusters’ (groups of 6-10) with clusters commencing in random order.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: A priori power calculation is based on self-reported quality of life WHOQoL-Bref. Assumptions include a=0.05 (type I error rate), ß=0.2 (type II error rate), and power=0.8 (80%). 126 participants are required to detect a minimum effect of 0.5 units (SD=19.4) between control and intervention conditions post-intervention.
Statistical analysis:
Quantitative: Within and between-group analysis will be conducted with differences considered significant at a=0.05. Analysis will be conducted according to the methods of Hussey and Hughes (2007) who have produced a guide to analysis for the (relatively new) stepped wedge cluster design. A Linear Mixed Model (LMM) will be used as this allows for non-independence in the data including clustering and repeated measures. Weighted Least Squares (‘Weighted Linear Regression’) will be used to estimate the fixed effects.
Qualitative: Grounded theory approach according to the techniques of Bryant and Charmaz (2007). Steps include: data familiarisation, code generation (for themes, keywords, phrases), grouping and hierarchy creation, and categorisation of codes and relationship identification (Braun & Clarke, 2006; MAXQDA, 2020). Thematic review and definition will be conducted by 3 independent authors (TT, CA, DM) who will then discuss their findings to reach consensus. Interviews will continue until data saturation (no new themes emerging).

References:
Braun, V. and V. Clarke, Using thematic analysis in psychology. Qualitative research in psychology, 2006. 3(2): p. 77-101.
Bryant, A. and K. Charmaz, The SAGE Handbook of Grounded Theory. 2007, Los Angeles: Sage.
Hussey, M.A. and J.P. Hughes, Design and analysis of stepped wedge cluster randomized trials. Contemporary clinical trials, 2007. 28(2): p. 182-191.
MAXQDA. Grounded Theory Analysis with MAXQDA: Step-By-Step Guide. 2020

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2020
Actual
Date of last participant enrolment
Anticipated
1/12/2022
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment postcode(s) [1] 31183 0
2120 - Thornleigh
Recruitment postcode(s) [2] 31184 0
4218 - Mermaid Beach

Funding & Sponsors
Funding source category [1] 306679 0
Charities/Societies/Foundations
Name [1] 306679 0
Primary & Community Care Services
Country [1] 306679 0
Australia
Funding source category [2] 306680 0
University
Name [2] 306680 0
Southern Cross University
Country [2] 306680 0
Australia
Primary sponsor type
Individual
Name
Tamsin Thomas
Address
Southern Cross University
Southern Cross Drive
Bilinga QLD 4225
Country
Australia
Secondary sponsor category [1] 307505 0
University
Name [1] 307505 0
Southern Cross University
Address [1] 307505 0
Southern Cross University
Military Rd, East Lismore NSW 2480
Country [1] 307505 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306858 0
Southern Cross University Human Research Ethics Committee (HREC)
Ethics committee address [1] 306858 0
Ethics committee country [1] 306858 0
Australia
Date submitted for ethics approval [1] 306858 0
31/08/2020
Approval date [1] 306858 0
29/09/2020
Ethics approval number [1] 306858 0
2020/133

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

Contacts
Principal investigator
Name 105254 0
Ms Tamsin Thomas
Address 105254 0
Southern Cross University
Southern Cross Drive
Bilinga QLD 4225
Country 105254 0
Australia
Phone 105254 0
+617 5589 3316
Fax 105254 0
Email 105254 0
[email protected]
Contact person for public queries
Name 105255 0
Tamsin Thomas
Address 105255 0
Southern Cross University
Southern Cross Drive
Bilinga QLD 4225
Country 105255 0
Australia
Phone 105255 0
+617 5589 3316
Fax 105255 0
Email 105255 0
[email protected]
Contact person for scientific queries
Name 105256 0
Tamsin Thomas
Address 105256 0
Southern Cross University
Southern Cross Drive
Bilinga QLD 4225
Country 105256 0
Australia
Phone 105256 0
+617 5589 3316
Fax 105256 0
Email 105256 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?
Raw scores for all questionnaires will be available.
Transcripts of all interviews will be available.
Any data that could reasonably identify an individual participant will be redacted.
When will data be available (start and end dates)?
Upon completion of analysis (late 2022) for 12 months.
Approx. January 2023-December 2023.
Available to whom?
Academics employed at research institutions.
Available for what types of analyses?
IPD meta-analysis only (with permission from lead investigator).
All other analyses require consent from the lead investigator.
How or where can data be obtained?
Request from Principle Investigator at:
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9094Ethical approval  [email protected] 380549-(Uploaded-12-10-2020-13-23-34)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.