GreenME Nature-based therapy evaluation, case - Battirame

ISRCTN	ISRCTN76221696
DOI	https://doi.org/10.1186/ISRCTN76221696
Horizon Europe	Horizon Europe Grant Agreement 101084198
Sponsor	University of Bologna
Funder	Horizon 2020 Framework Programme

Submission date: 09/12/2025
Registration date: 13/02/2026
Last edited: 13/02/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The rising prevalence of mental health disorders, including anxiety and depression, represents a major global health challenge. Although traditional treatments can be effective, they often involve limitations such as high costs, side effects, and restricted accessibility.
In contrast, exposure to natural environments has been shown to reduce stress, improve mood, and enhance cognitive functioning, among other health benefits. Therapeutic interventions delivered in nature (here referred to as nature-based therapies or NBTs) by trained professionals may further amplify these positive effects. Professional guidance can support individuals in developing coping strategies, building resilience, and strengthening their connection with the natural world. However, these therapies also face challenges, particularly related to cost and limited acceptance within the medical community.
This study seeks to strengthen the scientific evidence concerning whether and how NBTs improve mental health and wellbeing, and whether they offer a relatively low-cost alternative to other treatments. Focusing on individuals who experience significant daily stress, the study will examine whether nature-based therapies are more effective than alternative interventions in improving mental health. It will also assess whether NBTs represent a cost-efficient option for treating mental health conditions.

Who can participate?
Participants must meet the following criteria:
1. Aged 18–75 years
2. Willing and able to participate in the therapeutic horticulture program
3. Experience stress that interferes with daily life (as assessed by the screening questionnaire)
Additionally, either:
1. Frequently experience discrimination or prejudice in daily life, or
2. Experience poor sleep quality, poor mood, low energy, sadness, fatigue, or anxiety (as assessed by the screening questionnaire)
3. Have not participated in a similar nature-based therapy program within the past month

What does the study involve?
Participation includes:
1. Completing questionnaires about your health, wellbeing, experiences, and personal characteristics before the study begins.
2. Taking part in a 12-week therapeutic horticulture program, with one 120-minute session per week, or participating in an alternative program of equivalent duration. Participants will be randomly assigned to either the therapeutic horticulture group or the alternative program.
3. Completing follow-up questionnaires about your experiences, health, and wellbeing at three timepoints: immediately after the program ends, 1 month later, and 3 months later.

What are the possible benefits and risks of participating?
Your participation may help expand scientific understanding of the benefits of nature-based therapies, potentially improving the availability and quality of such programs in the future. You may also personally benefit from the therapeutic horticulture program or from the alternative intervention offered as part of the study. We do not foresee any serious risks from participating in the study. However, it is possible that participants may experience physical discomfort during some of the activities, and may find it difficult to complete the questionnaires.

Where is the study run from?
Eta Beta Cooperativa Sociale (Italy)

When is the study starting and how long is it expected to run for?
The project starts on December, 15 and will run for 11 months.

Who is funding the study?
Horizon Europe

Who is the main contact?
Dr Michele D'Ostuni, michele.dostuni@unibo.it

Contact information

Dr Michele D'Ostuni
Scientific, Public

Viale Giovanni Fanin, 44
Bologna
40126
Italy

ORCID ID	0000-0002-9246-6099
Phone	+39 (0)3387038265
Email	michele.dostuni@gmail.com

Dr Giuseppina Pennisi
Principal investigator

Viale Giovanni Fanin, 44
Bologna
40126
Italy

ORCID ID	0000-0001-9377-4811
Phone	+39 (0)33795999
Email	giuseppina.pennisi@unibo.it

Mrs Virginia Cioncoloni
Scientific

Viale Giuseppe Fanin, 44
Bologna
40126
Italy

ORCID ID	0009-0004-8600-6071
Phone	+39 (0)3341346768
Email	michele.dostuni@unibo.it

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Crossover
Purpose	Basic science, Supportive care, Treatment
Scientific title	GreenME: Advancing Greencare in Europe: an integrated multi-scalar approach for the expansion of nature-based therapies to improve mental health equity
Study acronym	GreenME
Study objectives
Ethics approval(s)	Approved 11/03/2025, Comitato di Bioetica dell'Università di Bologna (Piazza Verdi 3, Bologna, 40126, Italy; +39 (0)51 2082043; comitato.bioetica@unibo.it), ref: 0075975
Health condition(s) or problem(s) studied	Poor sleep quality, poor mood, low energy levels, sadness, fatigue, anxiety
Intervention	Participant assignment to groups will be carried out randomly using a block randomization system. The allocation sequences will be computer-generated by an independent researcher from the Autonomous University of Barcelona (UAB) & the Open University of Catalonia (UOC) RCore, who will not be involved in participant recruitment. To ensure the integrity of the study, an academic member from the University of Bologna, not involved in recruitment, will print each sequence on a separate page and place it in a numbered envelope. Participants will be randomly assigned to one of the following groups: "Exposed" group: receives the intervention + conventional (non-restrictive) treatments. "Waiting list" group: receives only standard treatments (e.g., medication, social services). 1. Intervention (therapeutic horticulture): This intervention is designed as a recovery-oriented activity that – through therapeutic, health-promoting activities- fosters direct contact with nature. It is important to note that this intervention does not include formal psychological therapy. The specific activities will be tailored to each participant’s individual needs and preferences, ensuring a personalized approach that effectively addresses their specific challenges. Each participant will receive one session per week over consecutive 12 weeks with a total of twelve sessions. Each session will last 120 minutes. Only low-to-middle physical activities will be allowed during the exposure sessions. 2. Usual Care: The “waitlist” will be used as the control group
Intervention type	Behavioural
Primary outcome measure(s)	Perceived stress measured using Perceived Stress Scale 10 items (PSS-10) at 1. Screening (before the study starts); 2. Baseline 1 (before the study); 3. Follow-up 1 (end of intervention); 4. Follow-up 2 (1 months after intervention); 5. Follow-up 3 (3 months after the intervention) Quality of life measured using EuroQol 5 Dimensions 5 levels (EQ-5D-5L) at 1. Screening (before the study starts); 2. Baseline 1 (before the study); 3. Follow-up 1 (end of intervention); 4. Follow-up 2 (1 months after intervention); 5. Follow-up 3 (3 months after the intervention) Wellbeing measured using ONS-4 at 1. Screening (before the study starts); 2. Baseline 1 (before the study); 3. Follow-up 1 (end of intervention); 4. Follow-up 2 (1 months after intervention); 5. Follow-up 3 (3 months after the intervention)
Key secondary outcome measure(s)	Anxiety measured using General Anxiety Disorder-7 (GAD-7) at 1. Baseline 1 (before the study); 2. Follow-up 1 (end of intervention); 3. Follow-up 2 (1 months after intervention); 4. Follow-up 3 (3 months after the intervention) Sleep quality measured using Pittsburgh Sleep Quality Index-2 (PSQI-2) at 1. Baseline 1 (before the study); 2. Follow-up 1 (end of intervention); 3. Follow-up 2 (1 months after intervention); 4. Follow-up 3 (3 months after the intervention)
Completion date	15/11/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	78
Key inclusion criteria	1. Between the ages of 18–75 years 2. Comply with eligibility criteria to access and take part on the evaluated intervention 3. Stress interference in daily life being significantly or very significantly (as assessed by the screening questionnaire) 4. Either: often or very often experiences of discrimination or prejudices in daily life OR Yes experiencing persistent poor sleep quality/poor mood/low energy levels/sadness/fatigue /anxiety (as assessed by the screening questionnaire) 5. No previous (last month) or current participation in the same type of nature-based therapy we are evaluating
Key exclusion criteria	1. Intellectual disability (ICD-11 6A00) 2. Phobias that can highly impact the capacity to benefit from our evaluated interventions, such as social and insect-related phobias (ICD-11 6B02, 6B03, 6B04) 3. Dissociative behaviours (ICD-11 6B60, 6B61, 6B62, 6B63, 6B64, 6B65, 6B66, 6E65, 6B6Y, 6B6Z) 4. Mental or behavioural symptoms, signs or clinical findings that can highly impact the capacity of the intervention group to benefit from our evaluated interventions or that increases their potential to become difficult cases to handle by guides (ICD-11 MB23.0, MB23.R, MB23.S)
Date of first enrolment	15/12/2025
Date of final enrolment	15/04/2026

Locations

Countries of recruitment

Italy

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

09/12/2025: Study's existence confirmed by the Comitato di Bioetica dell'Università di Bologna.