Stress-related ProblemNESTNCT01849718
Nacadia Effect Study (NEST)
An observational study of Stress-related Problem, run by Anne Dahl Refshauge at 1 site in Denmark.
Trial summary
This research project deals with stress treatment in the form of garden therapy in the therapy garden Nacadia. The therapy Garden Nacadia has an evidence-based design that is specially designed for the treatment of stressed people. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Stress-related Problem
- How many people
- 84 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2013to Nov 2017
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The project has agreed with a number of surrounding municipalities that they refer participants of both genders who are 20-60 years of age to the project through the rehabilitation institutions 'Incita' and 'Væksthuset', WHO are external collaborators Affiliated with the local job centers. Furthermore, local citizens can through their own doctor / psychiatrist or if they are customers at the Insurance Company 'TopDanmark', join the project. They will be provided with detailed information about the project, the target group and the triage procedure.
Who may be able to join
- that they suffer from prolonged stress, and have been on sick leave for that reason in ½ -2 years
- There is no other significant and untreated physical illness behind the symptoms
- There is no other significant and untreated mental illness behind the symptoms, such as personality disorders, bipolar disorders, psychosis or a high degree of sociophobia
Who cannot join
- Suicidal tendencies or abuse problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nacadia Effect Study - Studying the Effect of Garden Therapy in Relations to People Suffering From Stress
This research project deals with stress treatment in the form of garden therapy in the therapy garden Nacadia. The therapy Garden Nacadia has an evidence-based design that is specially designed for the treatment of stressed people.
Nacadia-therapy can be described as a process in which the patient's health and well-being is assumed to enhance by the presence of the natural environment and through participating in meaningful gardening activities.
Read more
NEST concerns research on the effect of Nacadia-therapy. The study consists of randomized and longitudinal studies of the effects of Nacadia-therapy compared to acknowledged cognitive behavioral therapy (CBT).
The outcome measures for example consist of: ability to return to work, health care use, psychological measurements related to stress, health, quality of life and changes in medication use. Further, exploratory studies of the garden therapy in the form of observations and interviews will be performed, to get a better understanding of the garden and the garden activities' importance for the therapeutic purposes.
Hypothesis:
- garden therapy, in a designed natural environment, will lead to improved health and well-being for people who are off sick with stress-related disorders
Read the detailed description
In order to strengthen the project's quality as evidence-based research, the intervention is designed as a randomized controlled trial comparing two treatments on repeated measurements of the same variables over a period of time.
The treatment options in this study is Nacadia-therapy (garden therapy) and cognitive behavioral therapy (CBT - control group). Because the Nacadia-therapy uses a large number of hours, it has been decided to compare it with the longest conventional treatment that can be offered through the public health insurance of stress-related disorders such as anxiety and depression.
- Number of participants (N): 80
- 40 (n) Nacadia Therapy
- 40 (n) CBT
- Type of environment
- The therapy garden Nacadia (outdoors or greenhouse)
- Clinic (indoors)
- Therapists and staff
- 2 psychologists and a gardener
- 2 psychologists
- Length of treatment
- 10 weeks
- 10 weeks
- Treatment content
- 96 hours of Nacadia-therapy (including 79 hours of gardening therapy, 10x½ hour individual conversations, and 4x3 hours of transition conversation)
- 20 hours individual CBT (including 16 hours of treating conversational therapy and 4x1 hour of transition conversation)
- Treatment set-up
- Group of 8
- Individual
Consistent factors in the two treatment options:
- The psychologists involved in both therapy types are authorized, and trained in CBT.
- Conversational therapy: Psychotherapeutic conversations in both treatments are primarily based on CBT.
- The treatments have the same length of time of 10 weeks
Diverging factors in the two treatment options:
- Environment: In the Nacadia-therapy the treatment is taking place in a designed natural environment, and in CBT the treatment takes place in the psychologists' treatment rooms.
- The number of hours: In Nacadia-therapy the individual sessions last three hours, with two sessions per week the first and last week and three sessions a week in week 2-9. This gives a total of 96 hours, including 4 x 3 hours transition conversation and 10 x ½ hour individual interviews. In CBT, the duration of the individual sessions are one hour, and there are 1-2 sessions per. week, totaling 20 hours, incl. 4 hours of transition conversations.
- Treatment content: in Nacadia-therapy experiences and activities related to the garden environment are integrated with mindfulness exercises. The individual conversations in the Nacadia-therapy will be mindfulness-based CBT, whereas in the control group the conversations will be exclusively CBT-based.
- Number of hours for conversational therapy: 20 hours of individual psychotherapy in CBT, 10 x ½ an hour for individual psychotherapy in Nacadia-therapy.
The project is targeted at citizens who are severely burdened by stress (including ICD categories, F 43.0-9(minus 1 = PTSD), and F45.3), which can be expected to correspond to 6-24 months sick leave.
Data Collection will be carried out through questionnaire surveys (at the beginning and ending of the treatment, and 3, 6, and 12 months after the treatment) as well as as well as from National Data Registers on use of Health care, medicine, and on amount of sick leave. This data will be retrieved three years before treatment and one year after treatment.
- Conditions
- Stress-related Problem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CBT - Cognitive Behavioural Therapy | 40 participants will receive cognitive behavioural therapy in a clinical setting. The duration of the individual sessions are one hour, and there are 1-2 sessions per. week, totaling 20 hours, incl. 4 hours of transition conversations. The conversations will be exclusively CBT-based. Number of hours for conversational therapy: 20 hours of individual psychotherapy | |
| Nacadia Therapy | 40 participants will receive garden therapy in a designed, natural environment. The individual sessions last three hours with two sessions per week the first and last week and three sessions per week in week 2-9. This gives a total of 96 hours, including 4 x 3 hours transition conversation and 10 x ½ hour individual interviews. Experiences and activities related to the garden environment are integrated with mindfulness exercises. The individual conversations in the Nacadia-therapy will be mindfulness-based CBT. 10 x ½ an hour of individual psychotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-related outcomes - quality of life
Measured: One year
Secondary outcomes (3)
Function and health - symptom relief
Measured: One year
Health economic evaluation - Cost efficiency (cost-effectiveness)
- Lower consumption of health care
- Resumption of work
Measured: One year
Patient-related outcome (quality of life)
- Cost utility
- Quality adjusted life years
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2016
- Study completionNov 2017
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 Stress-related ProblemStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anne Dahl Refshauge
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor-investigator, Anne Dahl Refshauge, University of Copenhagen
- Investigators
- Ulrika K Stigsdotter, Professor, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849718
- Sponsor's protocol ID
- NEST-704171
- Acronym
- NEST
- Status last verified
- Oct 2018
- First submitted
- 6 May 2013
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Stigsdotter UK, Corazon SS, Sidenius U, Nyed PK, Larsen HB, Fjorback LO. Efficacy of nature-based therapy for individuals with stress-related illnesses: randomised controlled trial. Br J Psychiatry. 2018 Jul;213(1):404-411. doi: 10.1192/bjp.2018.2. Epub 2018 May 25.
PubMed 29793558
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nacadia Effect Study - Studying the Effect of Garden Therapy in Relations to People Suffering From Stress
- ClinicalTrials.gov ID
- NCT01849718
- Acronym / sponsor ID
- NEST / NEST-704171
- Conditions
- Stress-related Problem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Anne Dahl RefshaugeUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- Aug 2013 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 8 May 2013 (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.
This research project deals with stress treatment in the form of garden therapy in the therapy garden Nacadia. The therapy Garden Nacadia has an evidence-based design that is specially designed for the treatment of stressed people.
Nacadia-therapy can be described as a process in which the patient's health and well-being is assumed to enhance by the presence of the natural environment and through participating in meaningful gardening activities.
NEST concerns research on the effect of Nacadia-therapy. The study consists of randomized and longitudinal studies of the effects of Nacadia-therapy compared to acknowledged cognitive behavioral therapy (CBT).
The outcome measures for example consist of: ability to return to work, health care use, psychological measurements related to stress, health, quality of life and changes in medication use. Further, exploratory studies of the garden therapy in the form of observations and interviews will be performed, to get a better understanding of the garden and the garden activities' importance for the therapeutic purposes.
Hypothesis:
- garden therapy, in a designed natural environment, will lead to improved health and well-being for people who are off sick with stress-related disorders
Detailed description
In order to strengthen the project's quality as evidence-based research, the intervention is designed as a randomized controlled trial comparing two treatments on repeated measurements of the same variables over a period of time.
The treatment options in this study is Nacadia-therapy (garden therapy) and cognitive behavioral therapy (CBT - control group). Because the Nacadia-therapy uses a large number of hours, it has been decided to compare it with the longest conventional treatment that can be offered through the public health insurance of stress-related disorders such as anxiety and depression.
- Number of participants (N): 80
- 40 (n) Nacadia Therapy
- 40 (n) CBT
- Type of environment
- The therapy garden Nacadia (outdoors or greenhouse)
- Clinic (indoors)
- Therapists and staff
- 2 psychologists and a gardener
- 2 psychologists
- Length of treatment
- 10 weeks
- 10 weeks
- Treatment content
- 96 hours of Nacadia-therapy (including 79 hours of gardening therapy, 10x½ hour individual conversations, and 4x3 hours of transition conversation)
- 20 hours individual CBT (including 16 hours of treating conversational therapy and 4x1 hour of transition conversation)
- Treatment set-up
- Group of 8
- Individual
Consistent factors in the two treatment options:
- The psychologists involved in both therapy types are authorized, and trained in CBT.
- Conversational therapy: Psychotherapeutic conversations in both treatments are primarily based on CBT.
- The treatments have the same length of time of 10 weeks
Diverging factors in the two treatment options:
- Environment: In the Nacadia-therapy the treatment is taking place in a designed natural environment, and in CBT the treatment takes place in the psychologists' treatment rooms.
- The number of hours: In Nacadia-therapy the individual sessions last three hours, with two sessions per week the first and last week and three sessions a week in week 2-9. This gives a total of 96 hours, including 4 x 3 hours transition conversation and 10 x ½ hour individual interviews. In CBT, the duration of the individual sessions are one hour, and there are 1-2 sessions per. week, totaling 20 hours, incl. 4 hours of transition conversations.
- Treatment content: in Nacadia-therapy experiences and activities related to the garden environment are integrated with mindfulness exercises. The individual conversations in the Nacadia-therapy will be mindfulness-based CBT, whereas in the control group the conversations will be exclusively CBT-based.
- Number of hours for conversational therapy: 20 hours of individual psychotherapy in CBT, 10 x ½ an hour for individual psychotherapy in Nacadia-therapy.
The project is targeted at citizens who are severely burdened by stress (including ICD categories, F 43.0-9(minus 1 = PTSD), and F45.3), which can be expected to correspond to 6-24 months sick leave.
Data Collection will be carried out through questionnaire surveys (at the beginning and ending of the treatment, and 3, 6, and 12 months after the treatment) as well as as well as from National Data Registers on use of Health care, medicine, and on amount of sick leave. This data will be retrieved three years before treatment and one year after treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT - Cognitive Behavioural Therapy | – | –40 participants will receive cognitive behavioural therapy in a clinical setting. The duration of the individual sessions are one hour, and there are 1-2 sessions per. week, totaling 20 hours, incl. 4 hours of transition conversations. The conversations will be exclusively CBT-based. Number of hours for conversational therapy: 20 hours of individual psychotherapy |
| Nacadia Therapy | – | –40 participants will receive garden therapy in a designed, natural environment. The individual sessions last three hours with two sessions per week the first and last week and three sessions per week in week 2-9. This gives a total of 96 hours, including 4 x 3 hours transition conversation and 10 x ½ hour individual interviews. Experiences and activities related to the garden environment are integrated with mindfulness exercises. The individual conversations in the Nacadia-therapy will be mindfulness-based CBT. 10 x ½ an hour of individual psychotherapy. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The project has agreed with a number of surrounding municipalities that they refer participants of both genders who are 20-60 years of age to the project through the rehabilitation institutions 'Incita' and 'Væksthuset', WHO are external collaborators Affiliated with the local job centers. Furthermore, local citizens can through their own doctor / psychiatrist or if they are customers at the Insurance Company 'TopDanmark', join the project. They will be provided with detailed information about the project, the target group and the triage procedure.
Key inclusion criteria (3 listed)
- that they suffer from prolonged stress, and have been on sick leave for that reason in ½ -2 years
- There is no other significant and untreated physical illness behind the symptoms
- There is no other significant and untreated mental illness behind the symptoms, such as personality disorders, bipolar disorders, psychosis or a high degree of sociophobia
Key exclusion criteria (1 listed)
- Suicidal tendencies or abuse problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient-related outcomes - quality of life
Time frame: One year
3 secondary outcomes
Function and health - symptom relief
Time frame: One year
Health economic evaluation - Cost efficiency (cost-effectiveness)
Time frame: One year
Patient-related outcome (quality of life)
Time frame: One year
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 15 Oct 2018.
- Derived from this study: PubMed 29793558Stigsdotter UK, Corazon SS, Sidenius U, Nyed PK, Larsen HB, Fjorback LO. Efficacy of nature-based therapy for individuals with stress-related illnesses: randomised controlled trial. Br J Psychiatry. 2018 Jul;213(1):404-411. doi: 10.1192/bjp.2018.2. Epub 2018 May 25.
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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.
Ulrika K Stigsdotter, Professor principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress-related Problem, run by Anne Dahl Refshauge at 1 site in Denmark.
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 3 inclusion and 1 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 15 Oct 2018. 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 Denmark. 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?
Patient-related outcomes - quality of life (time frame: One year). 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 NCT01849718, 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 15 Oct 2018.