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Nacadia Effect Study (NEST) (NEST)

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ClinicalTrials.gov Identifier: NCT01849718
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : October 15, 2018
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
Anne Dahl Refshauge, University of Copenhagen

Tracking Information
First Submitted Date May 6, 2013
First Posted Date May 8, 2013
Last Update Posted Date October 15, 2018
Actual Study Start Date August 2013
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2013)
Patient-related outcomes - quality of life [ Time Frame: One year ]
Original Primary Outcome Measures
 (submitted: May 6, 2013)
Ability to return to work [ Time Frame: One year ]
Change History Complete list of historical versions of study NCT01849718 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 23, 2013)
  • Function and health - symptom relief [ Time Frame: One year ]
  • Health economic evaluation - Cost efficiency (cost-effectiveness) [ Time Frame: One year ]
    1. Lower consumption of health care
    2. Resumption of work
  • Patient-related outcome (quality of life) [ Time Frame: One year ]
    1. Cost utility
    2. Quality adjusted life years
Original Secondary Outcome Measures
 (submitted: May 6, 2013)
Use of medication [ Time Frame: One year ]
Current Other Pre-specified Outcome Measures
 (submitted: May 23, 2013)
Nature consumption [ Time Frame: One year ]
Specifically for the garden therapy, the participants' nature consumption is a primary outcome
Original Other Pre-specified Outcome Measures
 (submitted: May 6, 2013)
  • Use of Health Care [ Time Frame: One year ]
  • Use of nature environments [ Time Frame: One year ]
 
Descriptive Information
Brief Title Nacadia Effect Study (NEST)
Official Title Nacadia Effect Study - Studying the Effect of Garden Therapy in Relations to People Suffering From Stress
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

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.

  1. Number of participants (N): 80

    1. 40 (n) Nacadia Therapy
    2. 40 (n) CBT
  2. Type of environment

    1. The therapy garden Nacadia (outdoors or greenhouse)
    2. Clinic (indoors)
  3. Therapists and staff

    1. 2 psychologists and a gardener
    2. 2 psychologists
  4. Length of treatment

    1. 10 weeks
    2. 10 weeks
  5. Treatment content

    1. 96 hours of Nacadia-therapy (including 79 hours of gardening therapy, 10x½ hour individual conversations, and 4x3 hours of transition conversation)
    2. 20 hours individual CBT (including 16 hours of treating conversational therapy and 4x1 hour of transition conversation)
  6. Treatment set-up

    1. Group of 8
    2. 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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability 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.
Condition Stress-related Problem
Intervention Not Provided
Study Groups/Cohorts
  • 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.

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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 12, 2018)
84
Original Estimated Enrollment
 (submitted: May 6, 2013)
80
Actual Study Completion Date November 2017
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Suicidal tendencies or abuse problems
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01849718
Other Study ID Numbers NEST-704171
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Anne Dahl Refshauge, University of Copenhagen
Study Sponsor Anne Dahl Refshauge
Collaborators University of Aarhus
Investigators
Principal Investigator: Ulrika K Stigsdotter, Professor University of Copenhagen
PRS Account University of Copenhagen
Verification Date October 2018