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Completed

NCT Number: NCT04141813

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

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/

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Key information

Conditions

Pilgrimage Behavior Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Teaching, Research & Innovation Unit - Parc Sanitari Sant Joan de Déu

Sant Boi de Llobregat, Barcelona, 08830, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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 .

Secondary outcomes

  1. Five Facet Mindfulness Questionnaire, 15-item form (FFMQ-15; Baer et al., 2012)

    Time frame: Through study completion, an average of 3 months

    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.

  2. Nonattachment Scale, short form (NAS-7; Elphinstone, Sahdra, & Ciarrochi, 2014)

    Time frame: Through study completion, an average of 3 months

    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.

  3. Engaged Living Scale (ELS; Trompetter et al., 2013)

    Time frame: Through study completion, an average of 3 months

    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.

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Collaborators

  • Federal University of São Paulo
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • Universidad de Zaragoza

Registry information

Official study title

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

Acronym: ULTREYA

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 28, 2019
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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