UAB-CAN RULL 2022 Study: Impact of Forest Baths on Emotional Well-being in People With Sub-clinical Symptomatology of Anxiety and Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Social support scores
研究概览
简要总结
The investigators intend to evaluate patients aged 18 to 99 years with symptoms of anxiety and/or mild depression. A randomized controlled clinical trial will be carried out to evaluate the impact of the guided practice of forest bathing.
详细描述
The practice of Shinrin-Yoku, also known as Forest Bathing, is an outdoor therapeutic modality with growing evidence suggesting positive effects on the psychological well-being and general health of individuals. However, its benefits have been studied mainly in Asian countries, needing further research to assess whether its benefits are also generalizable to other European-Mediterranean regions. To explore this question, the investigators intend to evaluate patients aged 18 to 99 years with symptoms of anxiety and/or mild depression. A randomized controlled clinical trial will be carried out to evaluate the impact of the guided practice of forest bathing. The participants will be randomly distributed in two arms, with a crossover design: arm A intervention + control; arm B control + intervention. Participation in this study consists of the execution of two sessions of guided forest bathing practice, and the completion of online evaluation forms before and after each session of guided forest bathing practice, for 24 hours afterwards, as well as before and after the program as a whole. The study includes clinical assessments, emotional well-being, social support and other complementary indicators. For hypothesis testing, a linear model of univariate analysis of variance intrasubject design will be applied to the dependent variables, with three phase conditions (pre, post and follow-up) and two treatment conditions (intervention vs. control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Men or women aged 18 to 65 years.
- •Voluntary signature of informed consent.
- •Symptomatology of anxiety and/or mild depression with mild interference in daily functioning.
- •Motivation, attitude and ability to work in a group.
- •Receptive attitude to learning new skills and sharing experiences.
排除标准
- •Serious psychiatric disorder: Major depressive disorder with or without psychotic symptoms, uncompensated major depressive episode, dysthymic disorder, presence of suicidal ideation or suicide attempts, personality disorder.
- •Lack of knowledge of Catalan and Spanish.
- •Disconformity with acceptable standards of conduct.
结局指标
主要结局
Change in Social support scores
时间窗: Pre-intervention, intrasession, intersession, post-intervention and follo-up evaluations are planned for 1 month. The assessments will be carried out before and after the intervention with a maximum duration of 45 minutes.
OSLO Scale 3
Change in Affect scores
时间窗: Pre-intervention, intrasession, intersession, post-intervention and follo-up evaluations are planned for 1 month. The assessments will be carried out before and after the intervention with a maximum duration of 45 minutes.
Positive and Negative Affect Checklist (PANAS-SF).
Change in Mood scores
时间窗: Pre-intervention, intrasession, intersession, post-intervention and follo-up evaluations are planned for 1 month. The assessments will be carried out before and after the intervention with a maximum duration of 45 minutes.
Profile of Mood States (POMS)
Change in Anxiety scores
时间窗: Pre-intervention, intrasession, intersession, post-intervention and follo-up evaluations are planned for 1 month. The assessments will be carried out before and after the intervention with a maximum duration of 45 minutes.
Generalized Anxiety Scale (GAD-7).
Change in State Mindfulness scores
时间窗: Pre-intervention, intrasession, intersession, post-intervention and follo-up evaluations are planned for 1 month. The assessments will be carried out before and after the intervention with a maximum duration of 45 minutes.
State Mindfulness Scale (SMS)
Change in Affective variables scores
时间窗: Pre-intervention, intrasession, intersession, post-intervention and follo-up evaluations are planned for 1 month. The assessments will be carried out before and after the intervention with a maximum duration of 45 minutes.
Self-Assessment Manikin (SAM)
Change in Depression scores
时间窗: Pre-intervention, intrasession, intersession, post-intervention and follo-up evaluations are planned for 1 month. The assessments will be carried out before and after the intervention with a maximum duration of 45 minutes.
Patient Health Questionnaire (PHQ-9).
Change in Well-Being scores
时间窗: Pre-intervention, intrasession, intersession, post-intervention and follo-up evaluations are planned for 1 month. The assessments will be carried out before and after the intervention with a maximum duration of 45 minutes.
Emotional Well-Being Scale
Change in Stress scores
时间窗: Pre-intervention, intrasession, intersession, post-intervention and follo-up evaluations are planned for 1 month. The assessments will be carried out before and after the intervention with a maximum duration of 45 minutes.
Ad hoc perceived stress item
次要结局
未报告次要终点
研究者
Laura Comendador-Vazquez
Psychologist
Corporacion Parc Tauli