NCT04897685

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable depression

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

2.2 years

First QC Date

May 18, 2021

Last Update Submit

June 28, 2021

Conditions

Keywords

nature-basedtherapy grouprecovery experiencesnature experiences

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Nature-based treatment group

EXPERIMENTAL

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

Behavioral: Flow with Nature

Control group

NO INTERVENTION

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

Interventions

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

Nature-based treatment group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Jyväskylä

Jyväskylä, 40014, Finland

Location

Institute of Rehabilitation, JAMK University of Applied Sciences

Jyväskylä, 40100, Finland

Location

Tampere University

Tampere, 33100, Finland

Location

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Kalevi Korpela, Professor

    Tampere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2021

First Posted

May 21, 2021

Study Start

January 1, 2019

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

July 1, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations