Clinical trial NCT04780646: Effects of Urban Nature on Stress and Quality of Life
Official title: Effects of Urban Nature on Stress and Quality of Life of Subjects With Elevated Stress Levels - a Three-armed Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress, Psychological
Keywords: Nature therapy
Stress
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of regular nature therapy in urban nature with guidance of a licensed nature therapist on stress, quality of life and physical symptoms of subjects with elevated stress levels.


Eligibility criteria: Inclusion Criteria:

* stress with at least 4 of 10 points on the Numeric Analogue Scale (NAS) at least 1 month
* at least 3 of the following 8 stress-associated symptoms: sleep disturbances, inappetence or increased appetite, shoulder neck tension/back pain, tension headache, concentration disturbances, exhaustion, nervousness/irritability, stress-associated digestive complaints.

Exclusion Criteria:

* serious acute or chronic diseases
* pregnancy or lactation
* known serious mental illness
* immobility or restriction for gymnastics exercises due to orthopaedic, neurological or other medical cause
* participation in another study

Primary outcomes:
measure: Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary outcomes:
measure: Zerssen symptom list (B-LR and B-LR')
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
measure: Maslach Burnout Inventory (MBI)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
measure: Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
measure: General Self-Efficacy Short Scale-3 (GSE-3)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
measure: Perceived Benefits of Nature Questionnaire (PBNQ)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
measure: Subjective Vitality Scale (SVS-G state)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
measure: Flourishing Scale (FS)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
measure: Profile of Mood States (POMS)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
measure: Sociodemographic Measurements
timeFrame: Date of Inclusion (Baseline)
measure: Behavioural questions: doctor visits and health
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
measure: Expectation questions
timeFrame: Date of Inclusion (Baseline)
measure: Behavioural questions: cigarette consumption
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
measure: Behavioural questions: alcohol consumption
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
measure: Behavioural questions: time in nature
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
measure: Behavioural questions: nature as priority
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
measure: Heart Rate (HR)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Heart Rate Variability (HRV)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Other outcomes:
measure: Qualitative interviews in individual interviews
timeFrame: 8 weeks after inclusion
Locations:
city: Berlin
country: Germany
facility: Charite University
Study officials:
affiliation: Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
name: Andreas Michalsen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: