- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04897685
Nature-based Treatment Group for Depression
The Effects of Nature-based Intervention in the Treatment of Depression: Multi-center, Randomized Controlled Trial in Finland
Study Overview
Detailed Description
This research investigates the outcomes of nature-based treatment groups in the treatment of adults with depression. In total, 147 participants were involved. Of them, 70 were randomized into DMT group and 77 into the control group. All participants received treatment as usual during the research. The inclusion criteria of the study were: a diagnoses of depression (ICD -diagnostic system), BDI-I score 10 or above (cut off score for mild depression), treatment contact in a health care service and 18-65 years of age. The exclusion criteria were: 1) active suicidal ideation, 2) psychotic symptoms, and 3) substance misuse that is on a critical level (Audit questionnaire scores above 10). Also, participants who had pain-related problems that restricted daily life or were pregnant were not admitted to the study.
Nature-based treatment group was facilitated by a health care professional and included 12 x 90 mins sessions within 12 weeks. Depressive symptoms (BDI-I), psychological distress (CORE-10), subjective well-being (SWEMWBS), ability to work/study (WAI), and nature experiences (ROS, KOLU) were assessed at three measurement points: pre-measurement at the baseline, post-measurement 12 weeks after the pre-treatment measurement, and a follow-up measurement three months after the post-treatment measurement.
This research includes a larger number of participants (N = 147) than have been involved in previous studies utilising randomised controlled trials in nature-based interventions. The research generates further information about the effectiveness of nature-based therapy groups in the rehabilitation of depression as it was conducted in five cities across Finland. This type of multi-centre research can provide a realistic picture of the typical practice of a range of health care professionals working with participants in various geographic locations.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Jyväskylä, Finland, 40014
- University of Jyväskylä
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Jyväskylä, Finland, 40100
- Institute of Rehabilitation, JAMK University of Applied Sciences
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Tampere, Finland, 33100
- Tampere University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A diagnoses of depression (ICD -diagnostic system)
- BDI-I score 10 or above
- Treatment contact in a health care service
- Motivated to commit to a 12-session treatment group taking place in nearby nature environments
- Able to communicate adequately in Finnish in order to participate
Exclusion Criteria:
- Active suicidal ideation
- Psychotic symptoms
- Substance misuse that is on a critical level
- Volunteers who had pain-related problems that restricted daily life or were pregnant were not admitted to the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Nature-based treatment group
The participants in the treatment group were offered 12 nature-based group therapy sessions in addition to standard care.
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Nature-based intervention was facilitated by a health care professional and included 12 x 90 mins sessions within 12 weeks.
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NO_INTERVENTION: Control group
The participants in the control group continued treatment as usual in the health care services.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from baseline depressive symptoms (Beck Depression Inventory; BDI-I) at 12-week post-treatment measurement.
Time Frame: 12 weeks
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BDI-I (Beck Depression Inventory - I) measures depressive symptoms with 21 items.
Each item is scored 0-3 and sum scores are calculated on the basis of participants' responses.
The total sum score can range from 0 to 63 and higher score indicates higher depression.
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12 weeks
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Change from post-treatment depressive symptoms (Beck Depression Inventory-I; BDI-I) at three-month follow-up measurement.
Time Frame: 3 months
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The change in depressive symptoms between the post-treatment measurement at the end of the 12-week intervention and the 3-month follow-up.
BDI-I (Beck Depression Inventory - I) measures depressive symptoms with 21 items.
Each item is scored 0-3 and sum scores are calculated on the basis of participants' responses.
The total sum score can range from 0 to 63 and higher score indicates higher depression.
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3 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Kalevi Korpela, Professor, Tampere University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JAMKUAS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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