Healthy Clinical Trial
Official title:
The Effect of a Contemplative Nature-based Intervention on Spiritual Well-being: a Randomized Controlled Trial
The goal of this randomized control trial is to test if contemplating in nature could benefit spiritual well-being in general adults. The main question it aims to answer is: Does a 2-week contemplative nature intervention improve spiritual well-being? Researchers will compare intervention conditions to active control (walking in nature) and passive control (waitlist) conditions to see if contemplating in nature works to improve spirituality. Participants in the intervention condition will walk for 10 minutes and then choose a nice spot to sit for 10 minutes. During these minutes they will be asked to be silently present and observe trees, plants, flowers, or other aspects of nature and contemplate their connectedness to nature and their own awareness. Then walk back 10 minutes. Participants in the active control condition will walk for 30 minutes without further instruction.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | September 4, 2024 |
Est. primary completion date | September 4, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - is 18 years or older; - has access to a nearby natural environment for walking and sitting activities such as a forest, park, or walking area; - possesses the physical ability to walk for half an hour; - has access to a computer or tablet with a stable internet connection and an email address; - is willing to commit half an hour to engage in nature walks 10 times over 14 days. Exclusion Criteria: - NA. |
Country | Name | City | State |
---|---|---|---|
Netherlands | University of Twente | Enschede | Overijssel |
Lead Sponsor | Collaborator |
---|---|
University of Twente |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Client satisfaction of intervention condition assessed by Client Satisfaction Questionnaire (CSQ-8) | A Likert scale scored from 1 (low satisfaction) to 4 (high satisfaction). Higher score means higher satisfaction with the intervention. | From post-intervention to short-term follow-up at 1 month. | |
Other | Client satisfaction of active control condition assessed by Client Satisfaction Questionnaire (CSQ-8) | A Likert scale scored from 1 (low satisfaction) to 4 (high satisfaction). Higher score means higher satisfaction with the intervention. | From post-intervention to short-term follow-up at 1 month. | |
Other | Client satisfaction of passive control condition assessed by Client Satisfaction Questionnaire (CSQ-8) | A Likert scale scored from 1 (low satisfaction) to 4 (high satisfaction). Higher score means higher satisfaction with the intervention. | From post-intervention to longer term follow-up at 3 months. | |
Other | Nature connectedness assessed by Connectedness to Nature Scale (CNS) | Items are rated on a 5-point scale with endpoints 1 (strongly disagree) and 5 (strongly agree). Higher score means higher sense of oneness with the natural world. | Change from baseline to post-intervention at 2 weeks. | |
Other | Nature connectedness assessed by Connectedness to Nature Scale (CNS) | Items are rated on a 5-point scale with endpoints 1 (strongly disagree) and 5 (strongly agree). Higher score means higher sense of oneness with the natural world. | Change from baseline to short-term follow-up at 1 month. | |
Other | Nature connectedness assessed by Connectedness to Nature Scale (CNS) | Items are rated on a 5-point scale with endpoints 1 (strongly disagree) and 5 (strongly agree). Higher score means higher sense of oneness with the natural world. | Change from baseline to longer-term follow-up at 3 months. | |
Other | Nature connectedness assessed by the single item Inclusion of Nature with Self scale (INS) | Participants were asked to select one of seven different sets of overlapping circles labeled ''self'' and ''nature.'' Scores ranged from 1 (where the circles touched but did not overlap) to 7 (where the two circles entirely overlapped). | Change from baseline to post-intervention at 2 weeks. | |
Other | Nature connectedness assessed by the single item Inclusion of Nature with Self scale (INS) | Participants were asked to select one of seven different sets of overlapping circles labeled ''self'' and ''nature.'' Scores ranged from 1 (where the circles touched but did not overlap) to 7 (where the two circles entirely overlapped). | Change from baseline to short-term follow-up at 1 month. | |
Other | Nature connectedness assessed by the single item Inclusion of Nature with Self scale (INS) | Participants were asked to select one of seven different sets of overlapping circles labeled ''self'' and ''nature.'' Scores ranged from 1 (where the circles touched but did not overlap) to 7 (where the two circles entirely overlapped). | Change from baseline to longer-term follow-up at 3 months. | |
Other | Well-being assessed by Mental Health Continuum-Short Form (MHC-SF) | A 6-point Likert scale scored from "never" to "every day". Higher score means higher level of well-being. | Change from baseline to post-intervention at 2 weeks. | |
Other | Well-being assessed by Mental Health Continuum-Short Form (MHC-SF) | A 6-point Likert scale scored from "never" to "every day". Higher score means higher level of well-being. | Change from baseline to short-term follow-up at 1 month. | |
Other | Well-being assessed by Mental Health Continuum-Short Form (MHC-SF) | A 6-point Likert scale scored from "never" to "every day". Higher score means higher level of well-being. | Change from baseline to longer-term follow-up at 3 months. | |
Other | Psychological well-being assessed by Brief INSPIRE-O | A 5-point Likert scale scored from 0 (not at all) to 4 (a lot). Higher score means higher psychological well-being. | Change from baseline to post-intervention at 2 weeks. | |
Other | Psychological well-being assessed by Brief INSPIRE-O | A 5-point Likert scale scored from 0 (not at all) to 4 (a lot). Higher score means higher psychological well-being. | Change from baseline to short-term follow-up at 1 month. | |
Other | Psychological well-being assessed by Brief INSPIRE-O | A 5-point Likert scale scored from 0 (not at all) to 4 (a lot). Higher score means higher psychological well-being. | Change from baseline to longer-term follow-up at 3 months. | |
Other | Stress assessed by Perceived Stress Scale (PSS) | A 5-point Likert scale scored from 0 (never) to 4 (very often). Higher score means higher level of perceived stress. | Change from baseline to post-intervention at 2 weeks. | |
Other | Stress assessed by Perceived Stress Scale (PSS) | A 5-point Likert scale scored from 0 (never) to 4 (very often). Higher score means higher level of perceived stress. | Change from baseline to short-term follow-up at 1 month. | |
Other | Stress assessed by Perceived Stress Scale (PSS) | A 5-point Likert scale scored from 0 (never) to 4 (very often). Higher score means higher level of perceived stress. | Change from baseline to longer-term follow-up at 3 months. | |
Primary | Spiritual well-being assessed by Spiritual Attitude and Involvement List Short Form (SAIL-SF) | On a 6-point Likert scale ranging from 1 (not at all) to 6 (to a very high degree), respondents rate in how far they think specific statements about spiritual well-being apply to themselves. Higher scores indicate higher scores of spiritual well-being. | Change from baseline to post-intervention at 2 weeks. | |
Primary | Spiritual well-being assessed by Spiritual Attitude and Involvement List Short Form (SAIL-SF) | On a 6-point Likert scale ranging from 1 (not at all) to 6 (to a very high degree), respondents rate in how far they think specific statements about spiritual well-being apply to themselves. Higher scores indicate higher scores of spiritual well-being. | Change from Baseline to Short-term follow-up at 1 month. | |
Primary | Spiritual well-being assessed by Spiritual Attitude and Involvement List Short Form (SAIL-SF) | On a 6-point Likert scale ranging from 1 (not at all) to 6 (to a very high degree), respondents rate in how far they think specific statements about spiritual well-being apply to themselves. Higher scores indicate higher scores of spiritual well-being. | Change from baseline to longer-term follow-up at 3 months. | |
Primary | Spiritual well-being assessed by Daily Spiritual Experience Scale (DSES) | The non-theistic items from DSES will be used. Ranging from 1 (multiple times a day) to 6 (never). The item responses were reverse coded prior to analysis so that larger values would reflect a higher level of daily spiritual experiences. | Change from baseline to post-intervention at 2 weeks. | |
Primary | Spiritual well-being assessed by Daily Spiritual Experience Scale (DSES) | The non-theistic items from DSES will be used. Ranging from 1 (multiple times a day) to 6 (never). The item responses were reverse coded prior to analysis so that larger values would reflect a higher level of daily spiritual experiences. | Change from baseline to short-term follow-up at 1 month. | |
Primary | Spiritual well-being assessed by Daily Spiritual Experience Scale (DSES) | The non-theistic items from DSES will be used. Ranging from 1 (multiple times a day) to 6 (never). The item responses were reverse coded prior to analysis so that larger values would reflect a higher level of daily spiritual experiences. | Change from baseline to longer-term follow-up at 3 months. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |