Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000206426p
Ethics application status
Submitted, not yet approved
Date submitted
30/01/2025
Date registered
21/02/2025
Date last updated
21/02/2025
Date data sharing statement initially provided
21/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Healing Climate-Related Trauma: Trialling Arts-Based and Nature-Based Compassion-Focused Groups
Scientific title
After the Floods: Evaluating Arts-Based and Nature-Based Compassion Programs
to Treat Climate Related Post-Traumatic Stress Disorder in Participants Impacted by a Natural Disaster in Northern NSW Between 2017-2024
Secondary ID [1] 313534 0
nil known
Universal Trial Number (UTN)
Trial acronym
HEART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post traumatic stress disorder 336000 0
Condition category
Condition code
Mental Health 332579 332579 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will compare the effectiveness of two compassion, group-based interventions for the treatment of disaster-related PTSD in Northern NSW communities: an Arts-Based Compassion (ABC) program and a Nature-Based Compassion (NBC) program. Both interventions are grounded in research on compassion-based programs and have been adapted to address the specific psychological impacts of climate-related trauma.

The ABC and NBC programs will be co-led by an Arts-based or Nature-based specialist, together with a Compassion-Focused Program trainer. The ABC program will be led by a highly respected local community artist who has co-led ABC projects since 2017. The NBC program will be led by a clinical psychologist and psychotherapist with experience in leading nature-based programs.

Sessions for both the ABC and NBC programs will be delivered by Compassion-Focused program trainers (with a background in counselling, arts or eco therapy) who will complete a 5-day group training approximately two months prior to the start of the intervention that will prepare them to deliver the compassion focused content and integrate their sections within the ABC/NBC program.

Arm 1: Arts Based Compassion (ABC) Program

The ABC program is a five-session (3-hour weekly session for 5 weeks) intervention that aims to foster compassion skills through engagement with visual arts. All ABC sessions are group sessions (approximately 12 participants per group) and will be held face-to-face in local, accessible, and familiar community venues (e.g., local halls) and the location, Block V at SCU. Participants will receive an ABC program booklet that has designed specifically for the study that includes education and activities centred around each weekly compassion theme. Each weekly ABC session will include:

1 Compassion Discussion (~20 minutes): A Compassion program trainer (trained counsellor or arts therapist) will lead a brief discussion on the session's compassion-related theme, drawing upon participants' life experiences and wisdom. Weekly themes will include: What is Compassion, Creating Safeness, and the Three Flows of Compassion (compassion for others, receiving compassion from others, self-compassion).

2 Compassion Through Art (~2 hours): Participants will engage in experiential art-making activities focused on the compassion-related theme of the day (e.g., compassion for others, self-compassion etc.). This section will be facilitated by the lead community artist, supported by the Compassion program trainer who will participate in art activities alongside the participants, and provide extra support as needed. A range of art materials (e.g., paints, crayons, magazines for collage) will be provided for participants to create compassion-related artworks. The ambience will be enhanced with participant-selected music and informal storytelling. The trainers will aim to create a safe, non-judgemental space for creativity and emotional expression.

3 Reflection and Sharing (~40 minutes): Participants will be invited to share the stories and inspirations behind their artworks, reflecting on how the day’s compassion theme manifests in their lives. The session will conclude with a compassion-based practice, such as soothing rhythm breathing, to help activate the parasympathetic nervous system.

Attendance (adherence) to the ABC sessions will be recorded by trainers at the beginning of each session.

Arm 2: Nature-Based Compassion (NBC) Program

The NBC program is a novel five-session (3-hour weekly session for 5 weeks) intervention that integrates compassion science principles with nature-based experiences to address the often-fractured relationship with the natural world following a climate-related disaster. Sessions for the NBC program are group sessions (approximately 12 participants per group) and will be held face-to face at the following locations

1. Tucki Tucki Recreation Park Walking Trail, (Lismore Council)
2. Picabeen Park, Bangalow (Byron Shire Council)
3. Booyong Flora Reserve (Big Scrub Landcare)
4. SCU Lismore campus grounds
5. Coastal walk from New Brighton Community Hall.

Participants in the NBC program will receive a participant program handout that has been specifically designed for the study that includes education and activities for each weekly compassion theme. Each weekly NBC session will include the following:

1. Compassion Discussion (~20 minutes): Similar to the ABC program, a Compassion program trainer (typically a trained counsellor or eco therapist) will lead a brief discussion on the session's compassion theme, with a specific focus on how it relates to experiences in nature. This discussion will be inclusive of diverse perspectives, recognising that while some participants may have a strong affinity with nature, others may have different or less direct relationships with the natural world due to various cultural, personal, or environmental factors.

2.Compassion Through Nature Connection (~2 hours): Participants will engage in guided nature-based practices in local outdoor settings, facilitated by a trained nature connection practitioner. (David Roland, the lead nature connection practitioner is a clinical psychologist). Practices are designed to be adaptable and respectful of participants' diverse experiences and connections with nature. The practices may include:
- Mindfulness and sensory awareness exercises
- Nature based reflections and meaning making activities
- Guided self-compassion exercises in nature

3 Reflection and Sharing (~40 minutes): Participants will gather to share their experiences, insights, and any meaningful moments of connection with nature and compassion. The session will close with a compassion-based practice and an invitation to explore nature connection practices between sessions.

Attendance (adherence) to the NBC sessions will be recorded by trainers at the beginning of each session.
Intervention code [1] 330120 0
Treatment: Other
Intervention code [2] 330121 0
Behaviour
Comparator / control treatment
Participants in the wait-list control group will act as a comparator/control treatment for the two active intervention arms (ABC and NBC) and receive no treatment during the active intervention time period (baseline to completion of week five). Once the active intervention arms are completed (post week 6), participants in the wait list control group will then be offered the opportunity to participate in the active intervention program (ABC or NBC). This ensures that all participants have access to the potential benefits of the interventions.
Control group
Active

Outcomes
Primary outcome [1] 340097 0
Assess change in post-traumatic stress disorder (PTSD) symptom severity
Timepoint [1] 340097 0
Baseline (week 0), post intervention follow up (week 6 primary timepoint), 2 month follow up (week 14)
Secondary outcome [1] 442653 0
Assess change in nature connection – participants' psychological responses to climate change
Timepoint [1] 442653 0
Baseline (week 0), post intervention follow up (week 6), 2 month follow up (week 14)
Secondary outcome [2] 442661 0
Assess change in post-traumatic growth – change in positive psychological changes experienced as a result of the struggle with highly challenging life circumstances
Timepoint [2] 442661 0
Baseline (week 0), post intervention follow up (week 6), 2 month follow up (week 14)
Secondary outcome [3] 442662 0
Assess change in social connection - change in social connectedness
Timepoint [3] 442662 0
Baseline (week 0), post intervention follow up (week 6), 2 month follow up (week 14)
Secondary outcome [4] 442686 0
Assess change in depression
Timepoint [4] 442686 0
Baseline (week 0), post intervention follow up (week 6), 2 month follow up (week 14)
Secondary outcome [5] 442687 0
Assess change in anxiety
Timepoint [5] 442687 0
Baseline (week 0), post intervention follow up (week 6), 2 month follow up (week 14)
Secondary outcome [6] 442688 0
Assess change in risky and harmful drinking patterns
Timepoint [6] 442688 0
Baseline (week 0), post intervention follow up (week 6), 2 month follow up (week 14)
Secondary outcome [7] 442694 0
Assess change in self-criticism
Timepoint [7] 442694 0
Baseline (week 0), post intervention follow up (week 6), 2 month follow up (week 14)
Secondary outcome [8] 442695 0
Assess change in climate anxiety
Timepoint [8] 442695 0
Baseline (week 0), post intervention follow up (week 6), 2 month follow up (week 14)
Secondary outcome [9] 442698 0
Assess change in compassion towards oneself
Timepoint [9] 442698 0
Baseline (week 0), week 1, week 2, week 3, week 4, week 5, post intervention follow up (week 6), 2 month follow up (week 14)
Secondary outcome [10] 442700 0
Assess cost-effectiveness - the cost effectiveness of the study interventions
Timepoint [10] 442700 0
Baseline (week 0), post intervention follow up (week 6), 2 month follow up (week 14)
Secondary outcome [11] 442703 0
Assess change in quality of life
Timepoint [11] 442703 0
Baseline (week 0), post intervention follow up (week 6), 2 month follow up (week 14)
Secondary outcome [12] 442706 0
Assess participants experience and reflections of the program - this will be assessed as a composite outcome
Timepoint [12] 442706 0
Post intervention (week 6)
Secondary outcome [13] 442821 0
Adverse events - any symptom, sign, illness or experience that develops or worsens in severity during the course of the study
Timepoint [13] 442821 0
Weeks one, two, three, four and five
Secondary outcome [14] 444775 0
Assess change in social connection - group cohesion
Timepoint [14] 444775 0
Post intervention (week 6)
Secondary outcome [15] 444783 0
Assess change in nature connection - participants subjective connection to nature
Timepoint [15] 444783 0
Baseline (week 0), post intervention follow up (week 6), 2 month follow up (week 14)

Eligibility
Key inclusion criteria
Key inclusion criteria
- Adults aged 18 years and older
- Impacted by a natural disaster in NNSW between 2017 - 2024
- Meet the criteria for 'probable PTSD' as measured by a score of >29 on the PTSD Checklist for DSM-5 (PCL-5)
- Adequate cognitive capacity and English language skills to provide informed consent and complete study assessments via clinical judgement of the PI
- Willing to engage in group sessions where there is a risk of loss of confidentiality
- Willing to complete study activities, including group intervention sessions, follow-up sessions, and completing evaluation instruments
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key exclusion criteria
- Any concurrent diagnosis that includes a sign/symptom of convulsions
- Current participation in another interventional clinical trial for PTSD, unless approved by the investigator in consultation with the PI
- Current suicide risk or likely to require hospitalisation for suicide risk
- Current or in the last 6 months experienced a psychotic or bipolar disorder episode
- Attendance at any appointment whilst affected by substance/s e.g., illicit drugs or alcohol

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)
central randomisation
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?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis will be conducted on an intention-to-treat basis, including all participants who were randomised, regardless of their adherence to the intervention or completion of follow-up assessments. Missing data will be handled using appropriate statistical methods, such as multiple imputation, depending on the nature and extent of missingness. Per protocol will also be conducted.

Descriptive statistics will be used to summarise participant characteristics and outcomes at each time point. Continuous variables will be reported as means and standard deviations or medians and interquartile ranges, as appropriate. Categorical variables will be reported as frequencies and percentages.

The primary outcome, change in PTSD symptoms (PCL-5 scores) from baseline to post-intervention and 2-month follow-up, will be analysed using a mixed-effects linear regression model. A random effect will be included for clustering due to the intervention being run in small groups and a random intercept to account for repeated measures. The model will include fixed effects for the intervention group, time, and their interaction. If there is no interaction, the waitlist will be compared to ABC and NBC Groups with all available data. Covariates such as age, gender, and baseline symptom severity may be included in the model if out of balance between groups.

Secondary outcomes will be analysed using similar mixed-effects linear regression models. Statisticians will be consulted at the analysis phase to ensure that each analysis decision is appropriate and well-supported.

Qualitative data from the semi-structured interviews will be analysed using thematic analysis. Interview transcripts will be coded inductively to identify emerging themes and patterns related to participant experiences, perceived benefits, and changes in their relationship with nature or arts engagement and lived experience. The analysis will be conducted iteratively, with codes and themes refined as new data are collected and analysed.

Exploratory analyses will be conducted to examine potential moderators and mediators of treatment effects, such as preference for ABC or NBC, strength of preference, and baseline characteristics. Subgroup analyses may also be performed based on factors such as age, gender, or baseline symptom severity.

All statistical tests will be two-tailed with a significance level of 0.05. The results will be reported as point estimates with 95% confidence intervals. Statistical analyses will be performed using appropriate software, such as SPSS, SAS, R, or Stata.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/05/2025
Actual
Date of last participant enrolment
Anticipated
1/05/2027
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
396
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317990 0
Government body
Name [1] 317990 0
National Health and Medical Research Council
Country [1] 317990 0
Australia
Funding source category [2] 317996 0
Other Collaborative groups
Name [2] 317996 0
The Peregrine Centre
Country [2] 317996 0
Australia
Funding source category [3] 318008 0
University
Name [3] 318008 0
Southern Cross University
Country [3] 318008 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
Country
Australia
Secondary sponsor category [1] 320340 0
None
Name [1] 320340 0
Address [1] 320340 0
Country [1] 320340 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316659 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 316659 0
Ethics committee country [1] 316659 0
Australia
Date submitted for ethics approval [1] 316659 0
18/11/2024
Approval date [1] 316659 0
Ethics approval number [1] 316659 0
Ethics committee name [2] 316885 0
Aboriginal Health & Medical Research Council Ethics Committee
Ethics committee address [2] 316885 0
Ethics committee country [2] 316885 0
Australia
Date submitted for ethics approval [2] 316885 0
14/01/2025
Approval date [2] 316885 0
Ethics approval number [2] 316885 0

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

Contacts
Principal investigator
Name 138566 0
Prof James Bennett-Levy
Address 138566 0
Southern Cross University Military Rd, Lismore NSW 2480
Country 138566 0
Australia
Phone 138566 0
+61 400031219
Fax 138566 0
Email 138566 0
[email protected]
Contact person for public queries
Name 138567 0
Christine Freer
Address 138567 0
Southern Cross University Military Rd, Lismore NSW 2480
Country 138567 0
Australia
Phone 138567 0
+61 418637904
Fax 138567 0
Email 138567 0
[email protected]
Contact person for scientific queries
Name 138568 0
James Bennett-Levy
Address 138568 0
Southern Cross University Military Rd, Lismore NSW 2480
Country 138568 0
Australia
Phone 138568 0
+61 400031219
Fax 138568 0
Email 138568 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Data sharing details for the trial still need to be decided upon at the next CI meeting.



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.