Stress-related ProblemNCT05451758
The Effectiveness of MBSR in Natural Environments
A study testing Mindfulness-based stress reduction (MBSR) in people with Stress-related Problem, run by University of Sheffield at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress-related Problem
- What is being tested?
- Mindfulness-based stress reduction (MBSR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Apr 2017to 13 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 and over
- Students and staff at the University of Sheffield
Who cannot join
- Having severe and enduring mental health conditions (i.e. people currently receiving treatment for such conditions).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Landscape Architecture, University of Sheffield
Sheffield
About this study
Official title: 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).
Read the detailed description
The experimental design combined MBSR with an environmental condition. Participants were randomly assigned to brief MBSR in one of the three different environments (i.e., natural outdoor environment, built outdoor environment and indoor environment). All participants were asked to attend the brief MBSR programme for 6 weeks with 1-hour sessions. The weekly MBSR session included sitting and body scanning meditation, mindfulness exercises and group discussion led by a qualified mindfulness facilitator. During the experiment, participants were asked to complete the same questions in DASS-21 four times: baseline, after 3 weeks, after 6 weeks (at the completion of the 6-week MBSR) and one-month follow-up. In addition, participants who attended at least five of the six MBSR sessions were invited to donate their hair samples to measure the change of their stress level.
- Conditions
- Stress-related Problem
- Being tested
- Mindfulness-based stress reduction (MBSR)
- Keywords
- Mindfulness, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reduction (MBSR)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Mindfulness-based stress reduction (MBSR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Change in HCC from baseline to one month after the completion of the 6-week MBSR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start20 Apr 2017
- Primary completion13 Dec 2017
- Study completion13 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress-related ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eun Yeong Choe, PhD, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451758
- Sponsor's protocol ID
- 150258786
- Status last verified
- Apr 2017
- First submitted
- 24 Jun 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of Natural Environments in the Effectiveness of a Mindfulness-based Stress Reduction (MBSR) Programme
- ClinicalTrials.gov ID
- NCT05451758
- Acronym / sponsor ID
- 150258786
- Conditions
- Stress-related Problem
- Keywords
- Mindfulness, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The experimental design combined MBSR with an environmental condition. Participants were randomly assigned to brief MBSR in one of the three different environments (i.e., natural outdoor environment, built outdoor environment and indoor environment). All participants were asked to attend the brief MBSR programme for 6 weeks with 1-hour sessions. The weekly MBSR session included sitting and body scanning meditation, mindfulness exercises and group discussion led by a qualified mindfulness facilitator. During the experiment, participants were asked to complete the same questions in DASS-21 four times: baseline, after 3 weeks, after 6 weeks (at the completion of the 6-week MBSR) and one-month follow-up. In addition, participants who attended at least five of the six MBSR sessions were invited to donate their hair samples to measure the change of their stress level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Natural outdoor environment | Experimental | Other: Mindfulness-based stress reduction (MBSR)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. |
| Built outdoor environment | Experimental | Other: Mindfulness-based stress reduction (MBSR)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. |
| Indoor environment | Experimental | Other: Mindfulness-based stress reduction (MBSR)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 and over
- Students and staff at the University of Sheffield
Key exclusion criteria (1 listed)
- Having severe and enduring mental health conditions (i.e. people currently receiving treatment for such conditions).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based stress reduction (MBSR)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. | Other | Built outdoor environment, Indoor environment, Natural outdoor environment |
Primary outcome
Change in positive and negative emotions
Time frame: Change in PANAS from baseline to one month after the completion of the 6-week MBSR
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 depression, anxiety and stress
Time frame: Change in DASS-21 from baseline to one month after the completion of the 6-week MBSR
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 hair cortisol concentration (HCC)
Time frame: Change in HCC from baseline to one month after the completion of the 6-week MBSR
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eun Yeong Choe, PhD principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction (MBSR) in people with Stress-related Problem, run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in positive and negative emotions (time frame: Change in PANAS from baseline to one month after the completion of the 6-week MBSR). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.