Psychiatric DecompensationJDMNCT02666339
Mélisses Garden: Effect on Anxious State in Adult Patients Hospitalized in Psychiatry
A study testing Hortitherapy in people with Psychiatric Decompensation, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Each hospitalization leads to stress and anxiety. This is particularly true in psychiatry, because of "decompensation". That is why therapeutic treatments are delivered quickly to treat these symptoms and to allow a better relationship with patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychiatric Decompensation
- What is being tested?
- Hortitherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2016to 27 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum 18 years old
- Adult patient in complete hospitalization in psychiatry at CHU St-Etienne, with an anxiety score > 8 at HAD-A (cut off)
- Patient with hospitalization programmed for at least 1 month
- Patient able to start a mediation
- Antitetanic cover up to date (quick test performed before the randomization)
- Patients who have given their informed consent before participation in the study or for patients under supervision , informed consent of the guardian
- Patient affiliated or entitled to a social security scheme
Who cannot join
- Rejection of the randomization
- Inability to complete the scales whatever the cause of this failure (language other than French, mental retardation ...).
- Patient whose behavior evaluated by the psychiatrist does not allow the indication of a mediation.
- Patient who already participated in the mediation of horticultural therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mélisses Garden: Effect of the Mediation by Care-garden on Anxious State in Adult Patients Hospitalized in Psychiatry (Prospective, Monocentric, Controlled, Randomized, Open in Two Parallel Groups Study)
Each hospitalization leads to stress and anxiety. This is particularly true in psychiatry, because of "decompensation". That is why therapeutic treatments are delivered quickly to treat these symptoms and to allow a better relationship with patients. This relationship patients-nursing staff called "therapeutic alliance" is needed in psychiatry. Moreover, other treatments added to the therapeutic ones are used, like mediation, to increase the patients' state of health.
These last years, numerous studies were based on hortitherapy or care-gardens. It consists in the use of plants with a medical staff (for example nurses). A lot demonstrated the efficacy of the care-gardens, but most of them showed methodological weaknesses.
That is why the investigators would like to perform a randomized study, controlled, and they aim to demonstrate the efficacy of hortitherapy on anxiety in patients allowed in adult psychiatry for at least 4 weeks.
Read the detailed description
Each hospitalization leads to stress and anxiety. This is particularly true in psychiatry, because of "decompensation" that increases anxiety and fear. That is why therapeutic treatments are delivered quickly to treat these symptoms and to allow a better relationship with patients. This relationship patients-nursing staff called "therapeutic alliance" is needed in psychiatry. Moreover, other treatments added to the therapeutic ones are used, like mediation, to increase the patients' state of health.
These last years, numerous studies were based on hortitherapy or care-gardens. It consists in the use of plants with a medical staff (for example nurses). A lot demonstrated the efficacy of the care-gardens, but most of them showed methodological weaknesses : no control group, no randomization, few patients. Furthermore, these studies were not performed with feared patients hospitalized in psychiatry.
That is why the investigators would like to perform a randomized study, controlled, and they aim to demonstrate the efficacy of hortitherapy on anxiety in patients allowed in adult psychiatry for at least 4 weeks. This study will be performed on 190 patients who will be included in one of these groups:
- Control group : only usual care
- Hortitherapy group : 2 hortitherapy sessions/week during 4 weeks, added at the usual care.
Anxiety will be evaluated with HAD-A scale that is a brief questionnaire (2 at 6 minutes). HAD-A is very sensitive at the modifications and allows to follow the evolution of the anxiety. This scale is easy to use by the nursing staff and shows an excellent reliability, by the way really adapted to this study. On another hand researchers will also focus on the effects on the therapeutic alliance and the persistence of the effects at week 8.
- Conditions
- Psychiatric Decompensation
- Being tested
- Usual care, Hortitherapy
- Keywords
- Hortitherapy, Care-garden, Anxiety, Therapeutic alliance
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
Usual care : drug therapy, nurse and physician consultations.
HortitherapyBehavioural
2 hortitherapy sessions/week during 4 weeks, added at the usual care.
| Study group | Role | What they receive |
|---|---|---|
| Hortitherapy group | Experimental | Hortitherapy + Usual care Receives: Behavioral: Hortitherapy |
| Control group | Active comparator | Usual care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the mediation by care-garden on anxious state in adult patients hospitalized in psychiatry
Score to HAD (anxiety scale)
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study start30 Sep 2016
- Primary completion27 Aug 2021
- Study completion27 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DecompensationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine MASSOUBRE, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666339
- Sponsor's protocol ID
- 1508192
- Other IDs
- 2016-A00057-44
- Acronym
- JDM
- Status last verified
- Nov 2021
- First submitted
- 15 Jan 2016
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Joubert A, Jankowski-Cherrier B, Rossi A, Teyssier L, Suraud V, Presle E, Pommier R, Massoubre C, Verot E. Impact of horticultural therapy on patients admitted to psychiatric wards, a randomised, controlled and open trial. Sci Rep. 2024 Jun 22;14(1):14378. doi: 10.1038/s41598-024-65168-0.
PubMed 38909093
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mélisses Garden: Effect of the Mediation by Care-garden on Anxious State in Adult Patients Hospitalized in Psychiatry (Prospective, Monocentric, Controlled, Randomized, Open in Two Parallel Groups Study)
- ClinicalTrials.gov ID
- NCT02666339
- Acronym / sponsor ID
- JDM / 1508192
- Conditions
- Psychiatric Decompensation
- Keywords
- Hortitherapy, Care-garden, Anxiety, Therapeutic alliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 30 Sep 2016 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Each hospitalization leads to stress and anxiety. This is particularly true in psychiatry, because of "decompensation". That is why therapeutic treatments are delivered quickly to treat these symptoms and to allow a better relationship with patients. This relationship patients-nursing staff called "therapeutic alliance" is needed in psychiatry. Moreover, other treatments added to the therapeutic ones are used, like mediation, to increase the patients' state of health.
These last years, numerous studies were based on hortitherapy or care-gardens. It consists in the use of plants with a medical staff (for example nurses). A lot demonstrated the efficacy of the care-gardens, but most of them showed methodological weaknesses.
That is why the investigators would like to perform a randomized study, controlled, and they aim to demonstrate the efficacy of hortitherapy on anxiety in patients allowed in adult psychiatry for at least 4 weeks.
Detailed description
Each hospitalization leads to stress and anxiety. This is particularly true in psychiatry, because of "decompensation" that increases anxiety and fear. That is why therapeutic treatments are delivered quickly to treat these symptoms and to allow a better relationship with patients. This relationship patients-nursing staff called "therapeutic alliance" is needed in psychiatry. Moreover, other treatments added to the therapeutic ones are used, like mediation, to increase the patients' state of health.
These last years, numerous studies were based on hortitherapy or care-gardens. It consists in the use of plants with a medical staff (for example nurses). A lot demonstrated the efficacy of the care-gardens, but most of them showed methodological weaknesses : no control group, no randomization, few patients. Furthermore, these studies were not performed with feared patients hospitalized in psychiatry.
That is why the investigators would like to perform a randomized study, controlled, and they aim to demonstrate the efficacy of hortitherapy on anxiety in patients allowed in adult psychiatry for at least 4 weeks. This study will be performed on 190 patients who will be included in one of these groups:
- Control group : only usual care
- Hortitherapy group : 2 hortitherapy sessions/week during 4 weeks, added at the usual care.
Anxiety will be evaluated with HAD-A scale that is a brief questionnaire (2 at 6 minutes). HAD-A is very sensitive at the modifications and allows to follow the evolution of the anxiety. This scale is easy to use by the nursing staff and shows an excellent reliability, by the way really adapted to this study. On another hand researchers will also focus on the effects on the therapeutic alliance and the persistence of the effects at week 8.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hortitherapy group | Experimental | Behavioral: HortitherapyHortitherapy + Usual care |
| Control group | Active comparator | Other: Usual careUsual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Minimum 18 years old
- Adult patient in complete hospitalization in psychiatry at CHU St-Etienne, with an anxiety score > 8 at HAD-A (cut off)
- Patient with hospitalization programmed for at least 1 month
- Patient able to start a mediation
- Antitetanic cover up to date (quick test performed before the randomization)
Key exclusion criteria (4 listed)
- Rejection of the randomization
- Inability to complete the scales whatever the cause of this failure (language other than French, mental retardation ...).
- Patient whose behavior evaluated by the psychiatrist does not allow the indication of a mediation.
- Patient who already participated in the mediation of horticultural therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careUsual care : drug therapy, nurse and physician consultations. | Other | Control group |
| Hortitherapy2 hortitherapy sessions/week during 4 weeks, added at the usual care. | Behavioural | Hortitherapy group |
Primary outcome
Effect of the mediation by care-garden on anxious state in adult patients hospitalized in psychiatry
Time frame: 1 Month
Score to HAD (anxiety scale)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Derived from this study: PubMed 38909093Joubert A, Jankowski-Cherrier B, Rossi A, Teyssier L, Suraud V, Presle E, Pommier R, Massoubre C, Verot E. Impact of horticultural therapy on patients admitted to psychiatric wards, a randomised, controlled and open trial. Sci Rep. 2024 Jun 22;14(1):14378. doi: 10.1038/s41598-024-65168-0.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine MASSOUBRE, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hortitherapy in people with Psychiatric Decompensation, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the mediation by care-garden on anxious state in adult patients hospitalized in psychiatry (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02666339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.