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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000896370
Ethics application status
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Approved
Date submitted
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29/03/2026
Date registered
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20/07/2026
Date last updated
Help: Date last updated
20/07/2026
Date data sharing statement initially provided
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20/07/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Home therapeutic gardening plus usual care versus health education plus usual care for recovery after a recent suicide attempt in adults in Caldas, Colombia
Scientific title
A pilot randomised controlled trial of a 16-week home therapeutic gardening intervention plus usual care versus attention-matched health education plus usual care on recovery, depressive symptoms, and subjective well-being after a recent suicide attempt in adults in Caldas, Colombia
Additional trial identifiers [1] 316904 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Recent suicide attempt 341322 0
Depression 341323 0
Condition category
Condition code
Mental Health 337393 337393 0 0
Suicide
Mental Health 337394 337394 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Arm 1: Home therapeutic gardening intervention plus usual care

Participants allocated to the intervention arm will receive a manualised 16-week home therapeutic gardening programme delivered in addition to usual care. For this study, usual care is defined as the mental health care and follow-up ordinarily available through the participant's existing care pathway in Caldas, including clinical assessment or follow-up appointments, pharmacological or psychological treatment when indicated, crisis and safety management, referral to specialised services, and community or primary care follow-up according to local practice. Usual care will not be withheld or modified by study allocation.

The intervention is interdisciplinary and integrates agronomy, psychology, and family development. It includes one initial set-up session to assess available space and install a home garden using containers, pots, or small ground plots as feasible; provision of a basic gardening kit including containers, substrate, seeds or seedlings, and a practical illustrated guide; structured follow-up sessions focused on garden care, behavioural activation, routine building, achievable weekly goals, observation of progress, and optional but bounded family support; brief weekly follow-up contacts by phone or WhatsApp over the 16-week intervention period to review progress, adherence, barriers, and safety; and a closing phase aimed at maintenance and continuation of the gardening routine beyond the intervention period.

The intervention will be adapted to home conditions, including limited space and container-based gardening. Sessions and follow-up contacts will be delivered individually by trained staff from agronomy, psychology, and family development, at home and/or by telephone or WhatsApp according to participant circumstances and safety considerations.

Adherence will be monitored using participant gardening diaries or brief activity checklists, phone or WhatsApp contact logs, records of completed contacts, and staff checklists documenting completed gardening tasks, barriers, adverse events, and safety concerns. Intervention fidelity will be monitored using a structured fidelity checklist assessing delivery, dose, comprehension, implementation in the home, adherence-monitoring procedures, and safety procedures.
Intervention code [1] 333611 0
Lifestyle
Intervention code [2] 333612 0
Behaviour
Intervention code [3] 333613 0
Rehabilitation
Description of the comparator or control
Arm 2: Attention-matched health education plus usual care

Participants allocated to the control arm will receive usual care as defined for this study plus an attention-matched health education programme without gardening components. Usual care is defined as the mental health care and follow-up ordinarily available through the participant's existing care pathway in Caldas, including clinical assessment or follow-up appointments, pharmacological or psychological treatment when indicated, crisis and safety management, referral to specialised services, and community or primary care follow-up according to local practice. Usual care will not be withheld or modified by study allocation.

The attention-matched health education programme will be delivered individually by trained study staff over the 16-week intervention period. It will use the same planned contact frequency as the intervention arm, including brief weekly one-on-one telephone or WhatsApp contacts and structured education contacts delivered remotely or at home when appropriate. Contacts will provide education on healthy habits, continuity of mental health care, self-care, help-seeking, and access to services. No gardening kit, planting activities, or garden-related behavioural tasks will be provided.

Adherence to the comparator will be monitored using phone or WhatsApp call logs, records of completed contacts, and a brief checklist documenting the education topics delivered, participant engagement, barriers to participation, and any safety concerns.
Control group
Active

Outcomes
Primary outcome [1] 344912 0
Composite primary outcome: feasibility of recruitment and retention
Timepoint [1] 344912 0
From enrolment to week 16 post commencement of intervention.
Primary outcome [2] 344913 0
Composite primary outcome: intervention adherence and fidelity
Timepoint [2] 344913 0
Assessed over the 16-week intervention period and summarised at week 16 post commencement of intervention.
Primary outcome [3] 344914 0
Composite primary outcome: safety during the intervention period
Timepoint [3] 344914 0
From randomisation to week 16 post commencement of intervention.
Secondary outcome [1] 459739 0
Depressive symptoms
Timepoint [1] 459739 0
Baseline before randomisation; week 4, week 8, week 16 (end of intervention), and week 24 post commencement of intervention.
Secondary outcome [2] 459740 0
Subjective well-being
Timepoint [2] 459740 0
Baseline before randomisation; week 4, week 8, week 16 (end of intervention), and week 24 post commencement of intervention.
Secondary outcome [3] 459741 0
Continuity of mental health care
Timepoint [3] 459741 0
Baseline before randomisation; week 16 (end of intervention), and week 24 post commencement of intervention.
Secondary outcome [4] 459742 0
Psychosocial disability
Timepoint [4] 459742 0
Baseline before randomisation; week 16 (end of intervention), and week 24 post commencement of intervention.
Secondary outcome [5] 459743 0
Loneliness
Timepoint [5] 459743 0
Baseline before randomisation; week 16 (end of intervention), and week 24 post commencement of intervention.
Secondary outcome [6] 459744 0
Resilience
Timepoint [6] 459744 0
Baseline before randomisation; week 16 (end of intervention), and week 24 post commencement of intervention.
Secondary outcome [7] 459745 0
Healthy lifestyle habits
Timepoint [7] 459745 0
Baseline before randomisation; week 16 (end of intervention), and week 24 post commencement of intervention.
Secondary outcome [8] 465192 0
Barriers to mental health care
Timepoint [8] 465192 0
Baseline before randomisation; week 16 (end of intervention), and week 24 post commencement of intervention.
Secondary outcome [9] 465193 0
Out-of-pocket mental health expenditure
Timepoint [9] 465193 0
Baseline before randomisation; week 16 (end of intervention), and week 24 post commencement of intervention.
Secondary outcome [10] 465194 0
Perceived service experience
Timepoint [10] 465194 0
Baseline before randomisation; week 16 (end of intervention), and week 24 post commencement of intervention.

Eligibility
Key inclusion criteria
Adults aged 18 years or older.
• Resident in Caldas, Colombia.
• Documented suicide attempt within the previous 3 to 12 months.
• Clinically stable for outpatient participation at enrolment.
• Receiving usual care or linked to an active mental health care pathway.
• Able to provide informed consent.
• Able to participate in home-based or container-based gardening activities.
• Access to a telephone for follow-up contacts.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Acute suicidal risk requiring immediate intensive intervention at the time of enrolment.
• Current psychotic episode, acute mania, severe intoxication, or another acute mental state that prevents meaningful participation.
• Severe cognitive impairment precluding informed consent or valid participation.
• Medical condition that contraindicates light gardening-related activity.
• Planned move out of Caldas during the 16-week intervention period.
• Concurrent participation in another intensive behavioural intervention likely to interfere with study procedures.

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 allocation or sealed opaque sequentially numbered envelopes prepared by a person independent of recruitment and assessment. The enrolling researcher will not know the upcoming allocation at the time of participant enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random allocation sequence using permuted blocks of variable size (4 and 6), prepared by an independent statistician not involved in recruitment or intervention delivery.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This is a pilot randomised controlled trial. Analyses will primarily estimate feasibility, adherence, fidelity, retention, and safety parameters using descriptive statistics with 95% confidence intervals. Exploratory clinical analyses will follow the intention-to-treat principle. Repeated measures outcomes will be analysed using mixed-effects models including group, time, and group-by-time interaction terms, adjusted for baseline value and randomisation strata where appropriate. No formal efficacy claim is planned.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2026
Actual
Date of last participant enrolment
Anticipated
31/08/2026
Actual
Date of last data collection
Anticipated
15/02/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 27990 0
Colombia
State/province [1] 27990 0
caldas

Funding & Sponsors
Funding source category [1] 321500 0
Government body
Name [1] 321500 0
Alcaldia de Manizales
Country [1] 321500 0
Colombia
Primary sponsor type
University
Name
Universidad de Manizales
Address
Country
Colombia
Secondary sponsor category [1] 324259 0
None
Name [1] 324259 0
Address [1] 324259 0
Country [1] 324259 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320033 0
Comité de Bioética de la Universidad de Manizales
Ethics committee address [1] 320033 0
Ethics committee country [1] 320033 0
Colombia
Date submitted for ethics approval [1] 320033 0
31/10/2025
Approval date [1] 320033 0
24/11/2025
Ethics approval number [1] 320033 0
CBE11_2025

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

Contacts
Principal investigator
Name 149210 0
Prof Felipe Agudelo-Hernández
Address 149210 0
Full work address: Universidad de Manizales, Carrera 9A No. 19-03, Campo Hermoso, Manizales, Caldas, Colombia, 170001.
Country 149210 0
Colombia
Phone 149210 0
+57 314 6108744
Fax 149210 0
Email 149210 0
[email protected]
Contact person for public queries
Name 149211 0
Angela Aguirre Zuluaga
Address 149211 0
Full work address: Universidad de Manizales, Carrera 9A No. 19-03, Campo Hermoso, Manizales, Caldas, Colombia, 170001.
Country 149211 0
Colombia
Phone 149211 0
+57 316 2235165
Fax 149211 0
Email 149211 0
[email protected]
Contact person for scientific queries
Name 149212 0
Felipe Agudelo-Hernández
Address 149212 0
Full work address: Universidad de Manizales, Carrera 9A No. 19-03, Campo Hermoso, Manizales, Caldas, Colombia, 170001.
Country 149212 0
Colombia
Phone 149212 0
+57 314 6108744
Fax 149212 0
Email 149212 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: No. Individual participant data will not be shared because the dataset contains sensitive mental health and suicidal behaviour information from a regional clinical population and because data sharing is subject to ethics, sponsor, and participant-consent restrictions. Only aggregate results will be disseminated.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    _Aval_Bioetica_11_Andrés Felipe Agudelo H.pdf
Study protocol    HUERTA-CALDAS_protocolo_SPIRIT_16_semanas.docx


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.