PilgrimageULTREYANCT04141813
The Effects of the Pilgrimage in the Way of Saint James on Mental Health and Well-being (ULTREYA)
An observational study of Pilgrimage, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial summary
Objectives: This study aims to evaluate the effects of pilgrimage to Santiago de Compostela on mood, satisfaction with life, happiness, ability to pay attention to the present moment and the capacity to make choices in a more conscious and values-oriented way. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pilgrimage
- How many people
- 3,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2017to 30 Jun 2020
- Phase
- Observational
- 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
Study population: Pilgrims in the Way of Saint James.
Who may be able to join
- Adults (> 18 years old)
- Willing to go on pilgrimage in the Way of Saint James
- With or without previous experience in this pilgrimage
- Walking or cycling in the pilgrimage
- Finishing or not at "Santiago de Compostela"
- Ability to understand and read Spanish or English
- With internet access (via PC or smatphone)
- With signed informed consent to participate in the present study
Who cannot join
- Not walking for 4 or more days
- With incomplete baseline data
- With baseline/post assessments >1 month previous starting/ending the pilgrimage
Trial locations and contacts
1 site in 1 country.
Spain1 site
Teaching, Research & Innovation Unit - Parc Sanitari Sant Joan de Déu
Sant Boi de Llobregat, Barcelona, 08830
About this study
Official title: The Effects of the Pilgrimage in the Way of Saint James on Mental Health and Well-being (ULTREYA Project)
Objectives: This study aims to evaluate the effects of pilgrimage to Santiago de Compostela on mood, satisfaction with life, happiness, ability to pay attention to the present moment and the capacity to make choices in a more conscious and values-oriented way. Other personal aspects that could be related to the effects of the Camino and that may also mediate some of its effects (e.g., personal reasons for walking, socialization along the Camino, number of days walked, physical pain associated with walking, previous pilgrimages to Santiago, etc.) will be also assessed.
Methods: This is a naturalistic study with a 3-month follow-up. Voluntary participation of pilgrims doing one of the "Way of Saint James" routes will be requested. Participants will be asked to complete an online questionnaire with sociodemographic data and outcome measures (e.g. mindfulness, satisfaction with life, depression, stress, anxiety) before starting the Camino, at the end of the Camino and 3 months later. These evaluations will help us discover the effects of the Camino de Santiago on mental health and well-being in the short- and mid-term.
For more information (and/or to participate), go to: http://estudiocamino.org/
- Conditions
- Pilgrimage
- Keywords
- mindfulness, mental health, well-being, peregrination, walking, forest-bathing, outdoor therapy, wilderness therapy, adventure therapy
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pilgrims doing the "Camino de Santiago" (any route) | In the present study we utilized the "Ultreya" dataset. The Ultreya study is an online longitudinal study aimed at evaluating the effects of the pilgrimage on the Way of Saint James on mental health and wellbeing (www.estudiocamino.org). This pilgrimage involves hundreds of paths around Europe with a common termination at Santiago de Compostela (Spain), and it was one of the most important Christian pilgrimages during the Middle Ages. Currently, it is walked by thousands of people (>300,000 per year). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire, short form (PHQ-2; Kroenke, Spitzer, & Williams, 2003)
PHQ-2 is a 2-item measure assessing frequency of the two core depression symptoms (depressed mood and anhedonia) over the past two weeks, using a 4-point Likert scale (from 0= "not at all" to 3= "nearly every day"; total score ranges from 0 to 6). Higher scores indicate greater depressive symptoms.
Measured: Through study completion, an average of 3 months
General Anxiety Disorder scale, short form (GAD-2, Kroenke, Spitzer, Williams, Monahan, & Löwe, 2007)
GAD-2 is a 2-item scale that serves as an initial screening tool for generalized anxiety. Items are on a 4-point Likert scale (from 0= "not at all" to 3= "nearly every day"; total score ranges from 0 to 6). Higher scores indicate greater anxiety symptoms.
Measured: Through study completion, an average of 3 months
Perceived Stress Scale, short form (PSS-4; Cohen, Kamarck, & Mermelstein, 1983)
PSS-4 is a 4-item scale which measures the degree to which respondents appraised situations as stressful in the last month. Responses are scored on a Likert-scale between 0 = "never" and 4 = "very often" (total score ranges from 0 to 16). Higher scores indicate greater perceived stress.
Measured: Through study completion, an average of 3 months
Satisfaction with Life Scale (SWLS; Diener, Emmons, Larsen, & Griffin, 1985)
SWLS assesses global life satisfaction. It contains five items rated on a 7-point Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree") ( total scores range from 5 to 35). Higher scores indicate greater perceived satisfaction with life/wellbeing.
Measured: Through study completion, an average of 3 months
Subjective Happiness Scale (SHS; Lyubomirsky & Lepper, 1999)
SHS is a measure of global subjective happiness and consists of four items with a 7-point Likert-type scale. Mean total score ranges from 1 to 7, with greater scores indicating higher levels of perceived happiness.
Measured: Through study completion, an average of 3 months
International Positive and Negative Affect Schedule, short form (I.PANAS-SF; Thompson, 2007)
I-PANAS-SF is a 10-item version of the International Positive and Negative Affect Schedule (PANAS) to measure positive and negative affect. Items are on a 5-point scale that ranges from "never" (1) to "always" (5). Subscale scores (i.e. Positive affect or Negative affect) may range from 5 to 25 with higher scores meaning greater presence of positive or negative affect .
Measured: Through study completion, an average of 3 months
Secondary outcomes (3)
Five Facet Mindfulness Questionnaire, 15-item form (FFMQ-15; Baer et al., 2012)
FFMQ-15 measures trait-like tendency to be mindful in daily life and comprises five different facets with three items each (i.e. Observe, Describe, Act with Awareness, Nonreact, Nonjudge). Items are answered on a 5-point Likert-scale ranging from 1 ("never or very rarely true") to 5 ("very often or always true") with subscale scores ranging from 3 to 15. Higher scores indicate greater dispositional mindfulness.
Measured: Through study completion, an average of 3 months
Nonattachment Scale, short form (NAS-7; Elphinstone, Sahdra, & Ciarrochi, 2014)
The NAS-7 is a 7-item measure scored on a 6-point scale ranging from 1 = disagree strongly to 6 = agree strongly and designed to measure nonattachment. Its scores range from 7 to 42, with higher scores indicating greater nonattachment.
Measured: Through study completion, an average of 3 months
Engaged Living Scale (ELS; Trompetter et al., 2013)
The ELS is a 16-item scale, with each item rated on a five-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). It comprises two subscales: Valued Living (10 items; scores ranging from 10 to 50) and Life Fulfillment (6 items; with scores ranging from 6 to 30). Higher scores indicate greater perceived valued living or life fulfillment.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 Jun 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PilgrimageStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Universidad de Zaragoza, Federal University of São Paulo
- Responsible party
- Principal investigator, Juan Vicente Luciano, Fundació Sant Joan de Déu
- Investigators
- Javier García-Campayo, PhD, Principal investigator, Universidad de ZaragozaJoaquim Soler, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauMarcelo Demarzo, PhD, Principal investigator, Univesidad Federal de Sao PauloManu Mariño, MSc, Principal investigator, Quietud Mindfulness CentreJesús Montero-Marin, PhD, Principal investigator, Dharamsala Institute of Mindfulness and PsychotherapyAlbert Feliu-Soler, PhD, Principal investigator, Fundació Sant Joan de DéuJuan V Luciano, PhD, Principal investigator, Fundació Sant Joan de Déu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141813
- Sponsor's protocol ID
- PIC-141-19
- Acronym
- ULTREYA
- Status last verified
- Oct 2020
- First submitted
- 22 Oct 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Pilgrimage in the Way of Saint James on Mental Health and Well-being (ULTREYA Project)
- ClinicalTrials.gov ID
- NCT04141813
- Acronym / sponsor ID
- ULTREYA / PIC-141-19
- Conditions
- Pilgrimage
- Keywords
- mindfulness, mental health, well-being, peregrination, walking, forest-bathing, outdoor therapy, wilderness therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Universidad de Zaragoza, Federal University of São Paulo
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 28 Oct 2019 (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.
Objectives: This study aims to evaluate the effects of pilgrimage to Santiago de Compostela on mood, satisfaction with life, happiness, ability to pay attention to the present moment and the capacity to make choices in a more conscious and values-oriented way. Other personal aspects that could be related to the effects of the Camino and that may also mediate some of its effects (e.g., personal reasons for walking, socialization along the Camino, number of days walked, physical pain associated with walking, previous pilgrimages to Santiago, etc.) will be also assessed.
Methods: This is a naturalistic study with a 3-month follow-up. Voluntary participation of pilgrims doing one of the "Way of Saint James" routes will be requested. Participants will be asked to complete an online questionnaire with sociodemographic data and outcome measures (e.g. mindfulness, satisfaction with life, depression, stress, anxiety) before starting the Camino, at the end of the Camino and 3 months later. These evaluations will help us discover the effects of the Camino de Santiago on mental health and well-being in the short- and mid-term.
For more information (and/or to participate), go to: http://estudiocamino.org/
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilgrims doing the "Camino de Santiago" (any route) | – | –In the present study we utilized the "Ultreya" dataset. The Ultreya study is an online longitudinal study aimed at evaluating the effects of the pilgrimage on the Way of Saint James on mental health and wellbeing (www.estudiocamino.org). This pilgrimage involves hundreds of paths around Europe with a common termination at Santiago de Compostela (Spain), and it was one of the most important Christian pilgrimages during the Middle Ages. Currently, it is walked by thousands of people (>300,000 per year). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pilgrims in the Way of Saint James.
Key inclusion criteria (8 listed)
- Adults (> 18 years old)
- Willing to go on pilgrimage in the Way of Saint James
- With or without previous experience in this pilgrimage
- Walking or cycling in the pilgrimage
- Finishing or not at "Santiago de Compostela"
Key exclusion criteria (3 listed)
- Not walking for 4 or more days
- With incomplete baseline data
- With baseline/post assessments >1 month previous starting/ending the pilgrimage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Health Questionnaire, short form (PHQ-2; Kroenke, Spitzer, & Williams, 2003)
Time frame: Through study completion, an average of 3 months
PHQ-2 is a 2-item measure assessing frequency of the two core depression symptoms (depressed mood and anhedonia) over the past two weeks, using a 4-point Likert scale (from 0= "not at all" to 3= "nearly every day"; total score ranges from 0 to 6). Higher scores indicate greater depressive symptoms.
General Anxiety Disorder scale, short form (GAD-2, Kroenke, Spitzer, Williams, Monahan, & Löwe, 2007)
Time frame: Through study completion, an average of 3 months
GAD-2 is a 2-item scale that serves as an initial screening tool for generalized anxiety. Items are on a 4-point Likert scale (from 0= "not at all" to 3= "nearly every day"; total score ranges from 0 to 6). Higher scores indicate greater anxiety symptoms.
Perceived Stress Scale, short form (PSS-4; Cohen, Kamarck, & Mermelstein, 1983)
Time frame: Through study completion, an average of 3 months
PSS-4 is a 4-item scale which measures the degree to which respondents appraised situations as stressful in the last month. Responses are scored on a Likert-scale between 0 = "never" and 4 = "very often" (total score ranges from 0 to 16). Higher scores indicate greater perceived stress.
Satisfaction with Life Scale (SWLS; Diener, Emmons, Larsen, & Griffin, 1985)
Time frame: Through study completion, an average of 3 months
SWLS assesses global life satisfaction. It contains five items rated on a 7-point Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree") ( total scores range from 5 to 35). Higher scores indicate greater perceived satisfaction with life/wellbeing.
Subjective Happiness Scale (SHS; Lyubomirsky & Lepper, 1999)
Time frame: Through study completion, an average of 3 months
SHS is a measure of global subjective happiness and consists of four items with a 7-point Likert-type scale. Mean total score ranges from 1 to 7, with greater scores indicating higher levels of perceived happiness.
International Positive and Negative Affect Schedule, short form (I.PANAS-SF; Thompson, 2007)
Time frame: Through study completion, an average of 3 months
I-PANAS-SF is a 10-item version of the International Positive and Negative Affect Schedule (PANAS) to measure positive and negative affect. Items are on a 5-point scale that ranges from "never" (1) to "always" (5). Subscale scores (i.e. Positive affect or Negative affect) may range from 5 to 25 with higher scores meaning greater presence of positive or negative affect .
3 secondary outcomes
Five Facet Mindfulness Questionnaire, 15-item form (FFMQ-15; Baer et al., 2012)
Time frame: Through study completion, an average of 3 months
Nonattachment Scale, short form (NAS-7; Elphinstone, Sahdra, & Ciarrochi, 2014)
Time frame: Through study completion, an average of 3 months
Engaged Living Scale (ELS; Trompetter et al., 2013)
Time frame: Through study completion, an average of 3 months
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 22 Oct 2020.
- Study websiteLink provided by the sponsor.
- Ultreya project (Researchgate)Link provided by the sponsor.
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.
Javier García-Campayo, PhD principal investigator
Universidad de Zaragoza
Joaquim Soler, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Marcelo Demarzo, PhD principal investigator
Univesidad Federal de Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilgrimage, run by Fundació Sant Joan de Déu at 1 site in Spain.
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 8 inclusion and 3 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 22 Oct 2020. 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 Spain. 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?
Patient Health Questionnaire, short form (PHQ-2; Kroenke, Spitzer, & Williams, 2003) (time frame: Through study completion, an average of 3 months). The study lists 6 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 22 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.