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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04897685
Other study ID # JAMKUAS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date March 31, 2021

Study information

Verified date June 2021
Source JAMK University Of Applied Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 147
Est. completion date March 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Flow with Nature
Nature-based intervention was facilitated by a health care professional and included 12 x 90 mins sessions within 12 weeks.

Locations

Country Name City State
Finland Institute of Rehabilitation, JAMK University of Applied Sciences Jyväskylä
Finland University of Jyväskylä Jyväskylä
Finland Tampere University Tampere

Sponsors (3)

Lead Sponsor Collaborator
JAMK University Of Applied Sciences Tampere University, University of Jyvaskyla

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 weeks
Primary 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. 3 months
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