NCT04780646

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 22, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 29, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

2.3 years

First QC Date

February 22, 2021

Last Update Submit

October 24, 2023

Conditions

Stress, Psychological

Keywords

Nature therapyStress

Outcome Measures

Primary Outcomes (1)

  • Stress questionnaire (Cohen Perceived Stress Scale, CPSS)

    Change from Baseline in the CPSS, range from 0 to 4 in each item. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the positively stated items and then summing across all scale items while higher values meaning a higher grade of perceived stress.

    Date of Inclusion (Baseline), after 8 weeks and after 16 weeks

Secondary Outcomes (19)

  • Zerssen symptom list (B-LR and B-LR')

    Date of Inclusion (Baseline), after 8 weeks and after 16 weeks

  • International Physical Activity Questionnaire (IPAQ)

    Date of Inclusion (Baseline), after 8 weeks and after 16 weeks

  • Maslach Burnout Inventory (MBI)

    Date of Inclusion (Baseline), after 8 weeks and after 16 weeks

  • Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)

    Date of Inclusion (Baseline), after 8 weeks and after 16 weeks

  • General Self-Efficacy Short Scale-3 (GSE-3)

    Date of Inclusion (Baseline), after 8 weeks and after 16 weeks

  • +14 more secondary outcomes

Other Outcomes (1)

  • Qualitative interviews in individual interviews

    8 weeks after inclusion

Study Arms (3)

Nature therapy in urban nature

EXPERIMENTAL

Subjects receive a 90-minute nature therapy session once per week for 8 weeks with a licensed nature therapist, who explains exercises on perceiving nature and the connection between nature and health.

Behavioral: Nature therapy in urban nature

City Walk

ACTIVE COMPARATOR

Subjects receive a 90-minute city walk through urban sourroundings once per week for 8 weeks with a city guide, who talks about city architecture and gives information about the history of the surroundings.

Behavioral: City Walk

Waiting List

NO INTERVENTION

Subjects don't receive any therapy.

Interventions

Nature therapy in urban natureBEHAVIORAL

Nature therapy means visits in nature, actively perceiving the flora and fauna

Nature therapy in urban nature
City WalkBEHAVIORAL

City Walk means walking through urban surroundings (houses, streets, concrete..) with as little as possible contact to nature

City Walk

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University

Berlin, 14169, Germany

RECRUITING

MeSH Terms

Conditions

Stress, Psychological

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Andreas Michalsen, Prof. Dr.

    Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miriam Rösner

CONTACT

00493080505682m.roesner@immanuel.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 22, 2021

First Posted

March 3, 2021

Study Start

June 29, 2022

Primary Completion

October 15, 2024

Study Completion

December 15, 2024

Last Updated

October 25, 2023

Record last verified: 2023-10

Locations

DE(1)