NCT01849718

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

2.7 years

First QC Date

May 6, 2013

Last Update Submit

October 12, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient-related outcomes - quality of life

    One year

Secondary Outcomes (3)

  • Function and health - symptom relief

    One year

  • Health economic evaluation - Cost efficiency (cost-effectiveness)

    One year

  • Patient-related outcome (quality of life)

    One year

Other Outcomes (1)

  • Nature consumption

    One year

Study Arms (2)

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.

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Suicidal tendencies or abuse problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen

Copenhagen, Denmark

Location

Related Publications (1)

  • 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.

Study Officials

  • Ulrika K Stigsdotter, Professor

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Phd, Assistant Professor

Study Record Dates

First Submitted

May 6, 2013

First Posted

May 8, 2013

Study Start

August 1, 2013

Primary Completion

April 1, 2016

Study Completion

November 1, 2017

Last Updated

October 15, 2018

Record last verified: 2018-10

Locations