CClinicalTrials.gg
CompletedNCT04897685Updated Jul 1, 2021

Nature-based Treatment Group for Depression

An interventional study of Flow with Nature in Depression, sponsored by JAMK University Of Applied Sciences. Completed at 3 sites in Finland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-07-01.

Sponsored by JAMK University Of Applied Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
147
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Depression

Keywords

  • nature-based
  • therapy group
  • recovery experiences
  • nature experiences
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
147 participants (actual)

Study arms

  • Experimental
    Nature-based treatment group

    The participants in the treatment group were offered 12 nature-based group therapy sessions in addition to standard care.

    Behavioral: Flow with Nature

  • No intervention
    Control group

    The participants in the control group continued treatment as usual in the health care services.

Interventions

  • BehavioralFlow with Nature

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 3 months

06

Study locations

3 sites
  • University of Jyväskylä
    Jyväskylä, 40014, Finland
  • Institute of Rehabilitation, JAMK University of Applied Sciences
    Jyväskylä, 40100, Finland
  • Tampere University
    Tampere, 33100, Finland
07

References and documents

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04897685
Lead sponsor
JAMK University Of Applied Sciences
Collaborators
Tampere University, University of Jyvaskyla
Responsible party
Sponsor
First posted
May 21, 2021
Start date
Jan 1, 2019
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021
Last update
Jul 1, 2021

Study contacts

Kalevi Korpela, Professor
principal investigator · Tampere University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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