Condition category
Mental and Behavioural Disorders
Date applied
22/05/2013
Date assigned
29/08/2013
Last edited
09/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In the Western world stress is considered as one of the main factors related to modern lifestyle diseases. This research project deals with stress treatment in the form of garden therapy in therapy garden Nacadia. Nacadia therapy can be described as a process where the patient's health and well-being is assumed to be improved by the presence of the natural environment and by participating in meaningful gardening activities. The therapy consists of individual and group activities in the garden, such as gardening, walking, resting and talk therapy. The effect of the garden therapy will be compared with the well-established therapy form ‘Cognitive Behaviour Therapy’ (CBT). Half of the participants will receive garden therapy and the other half will receive CBT. The aim of this study is measure rate of return to work, frequency of use of healthcare, psychological measurements related to stress, health, quality of life and changes in medication use. A further aim is to see if the garden therapy is able to cure the participants just as successfully as the CBT.

Who can participate?
Men and women aged 20-60 years old who are suffering from prolonged stress and are on sick leave for that reason (3-24 months).

What does the study involve?
Participants will be randomly allocated to receive either garden therapy or CBT. The participants receiving garden treatment will visit the garden during ten weeks, two to three times a week for three hours in groups of eight. The participants receiving CBT will have individual sessions (20 hours in total) with a psychologist in a clinic during the same ten weeks. All participants will fill in five questionnaires (at the start, end and 3, 6 and 12 months after the treatment). The participants in the garden will also fill in log-books about their use of the garden and a researcher will do observation studies of the participants. Two of the participants will be interviewed after the observations.

What are the possible benefits and risks of participating?
Participating can be a demanding process and often requires that you challenge yourself mentally and physically. The benefit will be a better quality of life after the treatment.

Where is the study run from?
The study is run from the therapy garden Nacadia located in Hørsholm, as well as from two psychologist practices in Hillerød and Hørsholm, all north of Copenhagen, Denmark.

When is the study starting and how long is it expected to run for?
The study is starting in August 2013 and ends in April 2016. The last group will start in August 2014.

Who is funding the study?
The study is funded by the Tryg Foundation (Tryg Fonden Denmark).

Who is the main contact?
Professor Ulrika K Stigsdotter
uks@life.ku.dk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ulrika K. Stigsdotter

ORCID ID

Contact details

Københavns Universitet
Rolighedsvej 23
Frederiksberg
1958
Denmark
uks@life.ku.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01849718

Protocol/serial number

NEST-704171

Study information

Scientific title

Randomized controlled trial comparing two treatments of stress - Nacadia Therapy and Cognitive Behavioural Therapy - on repeated measurements of the same variables over a period of time

Acronym

NEST

Study hypothesis

Garden therapy, in a designed natural environment, will lead to improved health and well-being for people who are suffering from stress-related disorders and unable to maintain a job

Ethics approval

The study has been approved by the National Committee on Health Research Ethics, Copenhagen Region, Denmark, and has received the protocol number: H-1-2013-038. The study was approved 29/05/2013.

Study design

Randomized controlled trial. Exploratory studies of the garden therapy (observations and interviews)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Stress-related problem

Intervention

The two intervention 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.

1. Number of participants (N): 80
a. 40 (n) Nacadia Therapy
b. 40 (n) CBT

2.Type of environment
a. The therapy garden Nacadia (outdoors or greenhouse)
b. Clinic (indoors)

3.Therapists and staff
a. 2 psychologists and a gardener
b. 2 psychologists

4.Length of treatment
a. 10 weeks
b. 10 weeks

5.Treatment content
a. 96 hours of Nacadia-therapy (including 79 hours of gardening therapy, 10x½ hour individual conversations, and 4x3 hours of transition conversation)
b. 20 hours individual CBT (including 16 hours of treating converstaional therapy and 4x1 hour of transition conversation)

6.Treatment set-up
a. Group of 8
b. Individual

Consistent factors in the two treatment options:
1. The psychologists involved in both therapy types are authorized, and trained in CBT.
2. Conversational therapy: Psychotherapeutic conversations in both treatments are primarily based on CBT.
3. The treatments have the same length of time of 10 weeks

Diverging factors in the two treatment options:

1. 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.
2. 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.
3. 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.
4. Number of hours for conversational therapy: 20 hours of individual psychotherapy in CBT, 10 x ½ an hour for individual psychotherapy in Nacadia-therapy.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Ability to return to work
2. Use of medication
3. Use of Health Care

The outcomes are measured by treatment start and end (after 10 weeks) as well as 3, 6 and 12 months after the treatment has ended. Data on use of health care and medicine will be retracted from databases 3 years prior to the treatment and 1 year after the treatment.

Secondary outcome measures

Use of natural environments
The outcomes are measured by treatment start and end (after 10 weeks) as well as 3, 6 and 12 months after the treatment has ended.

Overall trial start date

01/08/2013

Overall trial end date

31/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

The project is targeted at citizens who are severely burdened by stress (including ICD categories, F 43.0-9 [excluding Post-traumatic stress disorder (PTSD), and F45.3], which can be expected to correspond to 6-24 months sick leave.

Other inclusion criteria:
1. That you are between 20-60 years old, male and female
2. That you suffer from prolonged stress, and have been on sick leave for that reason in ½ -2 years
3. You have no other significant and untreated physical illness behind the symptoms
4. You have no other significant and untreated mental illness behind the symptoms, such as personality disorders, bipolar disorders, psychosis or a high degree of sociophobia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

Suicidal tendencies or abuse problems

Recruitment start date

01/08/2013

Recruitment end date

31/10/2015

Locations

Countries of recruitment

Denmark

Trial participating centre

Københavns Universitet
Frederiksberg
1958
Denmark

Sponsor information

Organisation

Tryg Foundation (TrygFonden) (Denmark)

Sponsor details

Lyngby Hovedgade 4,2
Kgs. Lyngby
2800
Denmark
info@trygfonden.dk

Sponsor type

Not defined

Website

http://trygfonden.dk/

Funders

Funder type

Charity

Funder name

Tryg Foundation (TrygFonden) (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes