The Impact of Mindfulness and Spirituality on Student Well-being — MSW  

Depression Clinical Trial

Official title: The Impact of Mindfulness and Spirituality on Student Well-being-Efficacy Study

Status Completed

Clinical Trial Summary

The purpose of this research is to find effective ways of well-being promotion in higher education settings. A unique mindfulness training was developed that includes cognitive, emotional, social, and spiritual components. The training is being delivered during class-time of the following courses: Personal Development and College Success, Understanding Health Behavior, and Health Promotion and Disease Prevention. The objective of the study is to explore the training in regard to dosage effects and the incremental effect of spirituality. While the proximal targets of the intervention are well-being and stress, the ultimate targets are grades and persistence in college.

The hypotheses to be tested are:

• Mindfulness training will increase the well-being and decrease the stress, anxiety and depression symptomology of the participants.

• Mindfulness training will increase the functioning of the participants measured through GPA and hours spent in community engagement.

• The "mindfulness training with spiritual components" will have a greater impact than the "mindfulness only training" on well-being.

The study is designed as an experimental longitudinal study using a 2 X 3 factorial repeated measures design. The 2 level factor is mindfulness and mindfulness plus spirituality. The 3 level factor is the dose of the intervention (i.e., control, one class a week, and two classes a week).

Clinical Trial Description

This study is the efficacy study of the MSW pilot study (#519)(Fall 2017 and Spring 2018). It will have about 200 participants and will use biometric measures such as salivary cortisol and sleep quality, in addition to the self-report measures. The participants are the HDFS 1311 Personal Development and College Success, HLT 3301 Understanding Health Behavior Theory and Practice, and HLT3381 Health Promotion and Disease Prevention courses students. Two sections of the HDFS 1311 course were assigned to Mindfulness only, and Mindfulness with Spirituality training; another two sections are low-dose control groups, and one section is the no-treatment control group. HLT 3301 is assigned to be Mindfulness only, HLT3381is Mindfulness with Spirituality.

Acceptability and feasibility of the mindfulness training were pilot-tested during the 2017-2018 academic year. Participants thought that the training was helpful, engaging, practical, understandable, pleasant, and relevant to their life as a student at a rate between 94- 100%. The study defines spirituality as the diffusion of the transcendental meaning over the relationship with the self, the immediate social environment, and consequently the wider world. Thus, spirituality can potentially create meaning and purpose in one's life, a variable of which predicts academic self-regulation and GPA and positively related to the treatment of depression and anxiety.

The self-report measures are Pemberton Happiness Index; Five Facet Mindfulness Scale; Intrinsic Spirituality Scale; DASS Depression, Anxiety and Stress Scale; and Pittsburg Sleep Quality Index. The participants' GPA will be accessed through the UH Records Office if FERPA conditions are met.

The baseline data were collected at the beginning of the Fall semester and will be collected at the end of the semester. Additional follow-up data will be collected at the end of the Spring semester. The proximal outcomes of the study are well-being, stress, anxiety, depression, and fall semester grades. Adherence to intervention, intervention delivery quality, and participant engagement are going to be controlled through checklists filled by independent observers; instructor effect will be controlled by rotating the instructors.

The groups will be compared on all of the variables involved in this study, examining for dosage effects and effects of spirituality. There will also be an analysis of correlations between variables, such as the correlation between well-being and grades. The group comparison data have a multilevel structure, with repeated measures nested within individuals and individuals nested in classrooms. The initial plan is to conduct a 2X3 repeated measures ANOVA. If there are large differences in the groups on participant characteristics at baseline, a 2 X 3 ANCOVA will be used. If there are large intraclass correlations in the nested data, investigators will conduct multi-level modeling to examine group differences. ;

Related Conditions & MeSH terms

• Anxiety
• Depression
• Stress
• Well-being

• NCT number: NCT05397249
• Study type: Interventional
• Source: University of Houston
• Status: Completed
• Phase: N/A
• Start date: October 20, 2018
• Completion date: December 30, 2019