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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05451758
Other study ID # 150258786
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 20, 2017
Est. completion date December 13, 2017

Study information

Verified date April 2017
Source University of Sheffield
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date December 13, 2017
Est. primary completion date December 13, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
United Kingdom Department of Landscape Architecture, University of Sheffield Sheffield

Sponsors (1)

Lead Sponsor Collaborator
University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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