The Effects of the Pilgrimage in the Way of Saint James on Mental Health and Well-being (ULTREYA)

Study Overview
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Brief Summary
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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/

Official Title
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The Effects of the Pilgrimage in the Way of Saint James on Mental Health and Well-being (ULTREYA Project)

Conditions
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Pilgrimage

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Not walking for 4 or more days With incomplete baseline data With baseline/post assessments >1 month previous starting/ending the pilgrimage

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pilgrims doing the Camino de Santiago (any route)<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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 . | Through study completion, an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Through study completion, an average of 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mental health, mindfulness, well-being, peregrination, walking, forest-bathing, outdoor therapy, wilderness therapy, adventure therapy