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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04141813
Other study ID # PIC-141-19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2017
Est. completion date June 30, 2020

Study information

Verified date October 2020
Source Fundació Sant Joan de Déu
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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/


Recruitment information / eligibility

Status Completed
Enrollment 3000
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Teaching, Research & Innovation Unit - Parc Sanitari Sant Joan de Déu Sant Boi de Llobregat Barcelona

Sponsors (4)

Lead Sponsor Collaborator
Fundació Sant Joan de Déu Federal University of São Paulo, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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