Clinical trial NCT04141813: The Effects of the Pilgrimage in the Way of Saint James on Mental Health and Well-being (ULTREYA)
Official title: The Effects of the Pilgrimage in the Way of Saint James on Mental Health and Well-being (ULTREYA Project)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pilgrimage
Keywords: mindfulness
mental health
well-being
peregrination
walking
forest-bathing
outdoor therapy
wilderness therapy
adventure therapy
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Universidad de Zaragoza
name: Federal University of São Paulo
First posted: 2019-10-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pilgrims in the Way of Saint James.

Brief 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. 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/


Eligibility criteria: 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

Primary outcomes:
measure: Patient Health Questionnaire, short form (PHQ-2; Kroenke, Spitzer, & Williams, 2003)
timeFrame: Through study completion, an average of 3 months
measure: General Anxiety Disorder scale, short form (GAD-2, Kroenke, Spitzer, Williams, Monahan, & Löwe, 2007)
timeFrame: Through study completion, an average of 3 months
measure: Perceived Stress Scale, short form (PSS-4; Cohen, Kamarck, & Mermelstein, 1983)
timeFrame: Through study completion, an average of 3 months
measure: Satisfaction with Life Scale (SWLS; Diener, Emmons, Larsen, & Griffin, 1985)
timeFrame: Through study completion, an average of 3 months
measure: Subjective Happiness Scale (SHS; Lyubomirsky & Lepper, 1999)
timeFrame: Through study completion, an average of 3 months
measure: International Positive and Negative Affect Schedule, short form (I.PANAS-SF; Thompson, 2007)
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Five Facet Mindfulness Questionnaire, 15-item form (FFMQ-15; Baer et al., 2012)
timeFrame: Through study completion, an average of 3 months
measure: Nonattachment Scale, short form (NAS-7; Elphinstone, Sahdra, & Ciarrochi, 2014)
timeFrame: Through study completion, an average of 3 months
measure: Engaged Living Scale (ELS; Trompetter et al., 2013)
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Sant Boi de Llobregat
country: Spain
facility: Teaching, Research & Innovation Unit - Parc Sanitari Sant Joan de Déu
state: Barcelona
Study officials:
affiliation: Universidad de Zaragoza
name: Javier García-Campayo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Joaquim Soler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Univesidad Federal de Sao Paulo
name: Marcelo Demarzo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Quietud Mindfulness Centre
name: Manu Mariño, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Dharamsala Institute of Mindfulness and Psychotherapy
name: Jesús Montero-Marin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundació Sant Joan de Déu
name: Albert Feliu-Soler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundació Sant Joan de Déu
name: Juan V Luciano, PhD
role: PRINCIPAL_INVESTIGATOR
References: