- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05451758
The Effectiveness of MBSR in Natural Environments
Investigating the Role of Natural Environments in the Effectiveness of a Mindfulness-based Stress Reduction (MBSR) Programme
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sheffield, United Kingdom
- Department of Landscape Architecture, University of Sheffield
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults aged 18 and over
- Students and staff at the University of Sheffield
Exclusion Criteria:
- Having severe and enduring mental health conditions (i.e. people currently receiving treatment for such conditions).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Natural outdoor environment
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.
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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.
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Experimental: Built outdoor environment
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.
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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.
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Experimental: Indoor environment
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in positive and negative emotions
Time Frame: Change in PANAS from baseline to one month after the completion of the 6-week MBSR
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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
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Change in PANAS from baseline to one month after the completion of the 6-week MBSR
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Change in depression, anxiety and stress
Time Frame: Change in DASS-21 from baseline to one month after the completion of the 6-week MBSR
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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.
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Change in DASS-21 from baseline to one month after the completion of the 6-week MBSR
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Change in hair cortisol concentration (HCC)
Time Frame: Change in HCC from baseline to one month after the completion of the 6-week MBSR
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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.
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Change in HCC from baseline to one month after the completion of the 6-week MBSR
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eun Yeong Choe, PhD, University of Sheffield
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 150258786
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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