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临床试验/NCT04897685
NCT04897685已完成不适用

The Effects of Nature-based Intervention in the Treatment of Depression: Multi-center, Randomized Controlled Trial in Finland

JAMK University Of Applied Sciences6 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
147
试验地点
6
主要终点
Change from baseline depressive symptoms (Beck Depression Inventory; BDI-I) at 12-week post-treatment measurement.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change from baseline depressive symptoms (Beck Depression Inventory; BDI-I) at 12-week post-treatment measurement.

时间窗: 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.

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
JAMK University Of Applied Sciences
申办方类型
Other
责任方
Sponsor

研究点 (6)

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