NCT05451758

Brief Summary

With the prescription of antidepressants at record levels, and a huge demand for psychological therapies, health and social care providers are interested in cost-effective interventions to improve wellbeing and to prevent mental health problems. At the same time, there is a renewed interest in complementary and alternative therapies, such as yoga, meditation practices, and aromatherapy to support psychological resilience and prevent mental illness. Mindfulness practice has grown quickly as one such complementary and alternative approach to coping with certain forms of mental illness and symptoms of poor mental and physical health. The potential salutogenic benefits of mindfulness practice have been recognized, and mindfulness practice has received a great deal of attention as an intervention in a clinical/medical setting to address specific disorders (e.g. chronic pain or anxiety). The most widely used MBI is mindfulness-based stress reduction (MBSR), which offers an intensive 8-week programme (as well as shorter 4-6-week versions) involving a range of formal sitting and walking meditation, body scanning, mindful movement and informal mindfulness practices. Reviews of the effects and clinical effectiveness of MBSR indicate positive results in terms of the treatment of a range of different physiological and psychosocial conditions, including stress reduction and relief from emotional distress, depression and anxiety. Whilst this evidence demonstrates the significant mental health and wellbeing benefits of mindfulness-based interventions, there has been little research into combining mindfulness with restorative experiences, such as exposure to nature. The aim of the study is to investigate whether the effectiveness of MBSR are enhanced when combined with a natural environment. The investigators hypothesise that MBSR in a natural environment results in greater nature connectedness than in a built outdoor or an indoor environment (hypothesis 1). It is also hypothesised that MBSR achieves the best mental health and wellbeing outcomes when conducted in a natural environment (hypothesis 2).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2017

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
Last Updated

July 11, 2022

Status Verified

April 1, 2017

Enrollment Period

8 months

First QC Date

June 24, 2022

Last Update Submit

July 5, 2022

Conditions

Keywords

MindfulnessStress

Outcome Measures

Primary Outcomes (3)

  • Change in positive and negative emotions

    The Positive and Negative Affect Schedule (PANAS) measures hedonic wellbeing, eliciting respondent's current state across a wide variety of emotions. The PANAS contains two 10-item subscales designed to measure positive feelings (i.e. interested, excited, strong, enthusiastic, proud, alert, inspired, attentive, determined and active), and negative feelings (i.e. distressed, upset, guilty, scared, hostile, irritated, ashamed, nervous, jittery and afraid). Respondents were asked how much they felt each of the 20 emotions (1= not at all, 5= extremely). Scores ranged from 10 to 50 with higher scores indicating higher levels of positive or negative feelings

    Change in PANAS from baseline to one month after the completion of the 6-week MBSR

  • Change in depression, anxiety and stress

    Depression Anxiety Stress Scales (DASS-21) contains 21 psychological questions related to the symptoms of depression, anxiety and stress (Lovibond and Lovibond, 1995; Antony et al., 1998). The DASS-21 contains three self-report subscales with seven phrases that describe how respondents felt in the past week on a four-point scale (0= never, 3= almost always): e.g. Depression ("I felt that I had nothing to look forward to"); e.g. Anxiety ("I was worried about situations in which I might panic and make a fool of myself"); and e.g. Stress ("I found it difficult to relax"). Scores ranged from 0 to 42 with higher scores indicating higher levels of depression, anxiety and stress.

    Change in DASS-21 from baseline to one month after the completion of the 6-week MBSR

  • Change in hair cortisol concentration (HCC)

    Hair cortisol concentration (HCC) is used as a marker of chronic stress. Cortisol is commonly known as the stress hormone because it is released via the hypothalamic-pituitary-adrenal (HPA) in higher doses under stressful conditions.

    Change in HCC from baseline to one month after the completion of the 6-week MBSR

Study Arms (3)

Natural outdoor environment

EXPERIMENTAL

The park is a well-managed green space containing trees, shrubs, flower beds, lawns and a lake, and includes facilities such as benches, wooden bridges, a bandstand and monuments. The experiment was carried out in a location defined by planted areas containing shrubs and small trees, with some distant views.

Other: Mindfulness-based stress reduction (MBSR)

Built outdoor environment

EXPERIMENTAL

A courtyard on the university campus was chosen as a built outdoor environment. The courtyard was surrounded by concrete and brick built settings, with no visible vegetation.

Other: Mindfulness-based stress reduction (MBSR)

Indoor environment

EXPERIMENTAL

The indoor setting was a seminar room: a white painted room without windows in the basement of a university building. It contained chairs, a neutral coloured picture and no vegetation.

Other: Mindfulness-based stress reduction (MBSR)

Interventions

The participants were asked to attend a brief version of the MBSR programme lasting six weeks. The intervention was a structured 6-week programme with groups of between 6 and 10 participants. Each weekly session lasted one hour and included mindfulness meditation/exercises and group discussion led by a qualified mindfulness instructor.

Built outdoor environmentIndoor environmentNatural outdoor environment

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 and over
  • Students and staff at the University of Sheffield

You may not qualify if:

  • Having severe and enduring mental health conditions (i.e. people currently receiving treatment for such conditions).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Landscape Architecture, University of Sheffield

Sheffield, United Kingdom

Location

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Eun Yeong Choe, PhD

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2022

First Posted

July 11, 2022

Study Start

April 20, 2017

Primary Completion

December 13, 2017

Study Completion

December 13, 2017

Last Updated

July 11, 2022

Record last verified: 2017-04

Locations