DepressionNCT04897685
Nature-based Treatment Group for Depression
A study testing Flow with Nature in people with Depression, run by JAMK University Of Applied Sciences at 3 sites in Finland.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Flow with Nature
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 3 sitesFinland
- Study dates
- 1 Jan 2019to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
University of Jyväskylä
Jyväskylä, 40014
Institute of Rehabilitation, JAMK University of Applied Sciences
Jyväskylä, 40100
Tampere University
Tampere, 33100
About this study
Official title: The Effects of Nature-based Intervention in the Treatment of Depression: Multi-center, Randomized Controlled Trial in Finland
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Flow with Nature
- Keywords
- nature-based, therapy group, recovery experiences, nature experiences
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow with NatureBehavioural
Nature-based intervention was facilitated by a health care professional and included 12 x 90 mins sessions within 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nature-based treatment group | Experimental | The participants in the treatment group were offered 12 nature-based group therapy sessions in addition to standard care. Receives: Behavioral: Flow with Nature |
| Control group | No intervention | The participants in the control group continued treatment as usual in the health care services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start1 Jan 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- JAMK University Of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, University of Jyvaskyla
- Responsible party
- Sponsor
- Investigators
- Kalevi Korpela, Professor, Principal investigator, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897685
- Sponsor's protocol ID
- JAMKUAS
- Status last verified
- Jun 2021
- First submitted
- 18 May 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nature-based Intervention in the Treatment of Depression: Multi-center, Randomized Controlled Trial in Finland
- ClinicalTrials.gov ID
- NCT04897685
- Acronym / sponsor ID
- JAMKUAS
- Conditions
- Depression
- Keywords
- nature-based, therapy group, recovery experiences, nature experiences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- JAMK University Of Applied SciencesUniversity, hospital or other
- Collaborators
- Tampere University, University of Jyvaskyla
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nature-based treatment group | Experimental | Behavioral: Flow with NatureThe participants in the treatment group were offered 12 nature-based group therapy sessions in addition to standard care. |
| Control group | No intervention | –The participants in the control group continued treatment as usual in the health care services. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flow with NatureNature-based intervention was facilitated by a health care professional and included 12 x 90 mins sessions within 12 weeks. | Behavioural | Nature-based treatment group |
Primary outcome
Change from baseline depressive symptoms (Beck Depression Inventory; BDI-I) at 12-week post-treatment measurement.
Time frame: 12 weeks
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.
Time frame: 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Description of the research groupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kalevi Korpela, Professor principal investigator
Tampere University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flow with Nature in people with Depression, run by JAMK University Of Applied Sciences at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline depressive symptoms (Beck Depression Inventory; BDI-I) at 12-week post-treatment measurement. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.