Nature-based Treatment Group for Depression
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Flow with Nature
Sponsored by

About this trial
This is an interventional treatment trial for Depression focused on measuring nature-based, therapy group, recovery experiences, nature experiences
Eligibility Criteria
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
Sites / Locations
- University of Jyväskylä
- Institute of Rehabilitation, JAMK University of Applied Sciences
- Tampere University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nature-based treatment group
Control group
Arm Description
The participants in the treatment group were offered 12 nature-based group therapy sessions in addition to standard care.
The participants in the control group continued treatment as usual in the health care services.
Outcomes
Primary Outcome Measures
Change from baseline depressive symptoms (Beck Depression Inventory; BDI-I) at 12-week post-treatment measurement.
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.
Change from post-treatment depressive symptoms (Beck Depression Inventory-I; BDI-I) at three-month follow-up measurement.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04897685
First Posted
May 18, 2021
Last Updated
June 28, 2021
Sponsor
JAMK University Of Applied Sciences
Collaborators
Tampere University, University of Jyvaskyla
1. Study Identification
Unique Protocol Identification Number
NCT04897685
Brief Title
Nature-based Treatment Group for Depression
Official Title
The Effects of Nature-based Intervention in the Treatment of Depression: Multi-center, Randomized Controlled Trial in Finland
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JAMK University Of Applied Sciences
Collaborators
Tampere University, University of Jyvaskyla
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This multi-centre research investigates the effects of nature-based treatment group on participants diagnosed with depression. In total, 147 persons participated in the study in various locations in Finland. All participants received treatment as usual (TAU). They were randomised into nature-based group + TAU (n = 70) or TAU-only (n = 77). The participants in the nature-based group + TAU were offered 12 sessions once a week in addition to standard care. The measurement points included pre-treatment measurement at the baseline and post-treatment measurement at the end of the intervention, which was 12 weeks after the pre-treatment measurement. The follow-up measurement was 3 months after the post-treatment measurement. The effects of the intervention were assessed with a clinical measure of depression (BDI-I) and with indicators of psychological distress (CORE-10), subjective well-being (SWEMWBS), work/study ability (WAI) and nature experiences (ROS, KOLU). The participants in the treatment group (nature-based group +TAU) were compared to the participants in the control group who received TAU-only.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
nature-based, therapy group, recovery experiences, nature experiences
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nature-based treatment group
Arm Type
Experimental
Arm Description
The participants in the treatment group were offered 12 nature-based group therapy sessions in addition to standard care.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The participants in the control group continued treatment as usual in the health care services.
Intervention Type
Behavioral
Intervention Name(s)
Flow with Nature
Intervention Description
Nature-based intervention was facilitated by a health care professional and included 12 x 90 mins sessions within 12 weeks.
Primary Outcome Measure Information:
Title
Change from baseline depressive symptoms (Beck Depression Inventory; BDI-I) at 12-week post-treatment measurement.
Description
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.
Time Frame
12 weeks
Title
Change from post-treatment depressive symptoms (Beck Depression Inventory-I; BDI-I) at three-month follow-up measurement.
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kalevi Korpela, Professor
Organizational Affiliation
Tampere University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Jyväskylä
City
Jyväskylä
ZIP/Postal Code
40014
Country
Finland
Facility Name
Institute of Rehabilitation, JAMK University of Applied Sciences
City
Jyväskylä
ZIP/Postal Code
40100
Country
Finland
Facility Name
Tampere University
City
Tampere
ZIP/Postal Code
33100
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://research.tuni.fi/enviwell/
Description
Description of the research group
Learn more about this trial
Nature-based Treatment Group for Depression
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