Clinical trial NCT05397249: The Impact of Mindfulness and Spirituality on Student Well-being
Official title: The Impact of Mindfulness and Spirituality on Student Well-being-Efficacy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Well-being
Stress
Anxiety
Depression
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This 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).
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria: College students over 18. -

Exclusion Criteria: None

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Primary outcomes:
measure: Change in GPA
timeFrame: Collected at the beginning of the semester before the intervention started and at the end of the semester within two weeks period (November and December 2018), and 5 months after the completion of the intervention (May 2019)
measure: Change in reported well-being score measured by Pemberton Happiness Index
timeFrame: Study had 3 iterations. For all, data is collected at the beginning and end of the semester, before the intervention started, and at the end of the intervention. For 1 iteration, follow up data was collected 5 months after the intervention ended.
measure: Change in depression, anxiety, stress symptoms measured by Depression Anxiety Stress Scale
timeFrame: Study had 3 iterations. For all, data is collected at the beginning and end of the semester, before the intervention started, and at the end of the intervention. For 1 iteration, follow up data was collected 5 months after the intervention ended.
measure: salivary cortisol levels measured by Enzyme Immunoassay Technique
timeFrame: At the end of semester (November 2018) collected within a week period.
measure: time spent in deep, light, and REM sleep measured by activity tracker
timeFrame: At the end of semester (November 2018) collected within a week period.
measure: Change in sleep quality measured by Pittsburgh Sleep Quality Index
timeFrame: Collected only for the first iteration of the study:at the beginning and end of the semester, before the intervention started, and at the end of the intervention. For 1 iteration, follow up data was collected 5 months after the intervention ended.
measure: Change in Community Involvement
timeFrame: Collected only for the first iteration of the study:at the beginning and end of the semester, before the intervention started, and at the end of the intervention. For 1 iteration, follow up data was collected 5 months after the intervention ended.
Secondary outcomes:
measure: Change in reported mindfulness score measured by Five Facet Mindfulness Questionnaire
timeFrame: Collected only for the first iteration of the study:at the beginning and end of the semester, before the intervention started, and at the end of the intervention. For 1 iteration, follow up data was collected 5 months after the intervention ended.
measure: Change in reported spirituality measured by Intrinsic Spirituality Scale
timeFrame: Collected only for the first iteration of the study:at the beginning and end of the semester, before the intervention started, and at the end of the intervention. For 1 iteration, follow up data was collected 5 months after the intervention ended.
measure: Change in reported affect measured by Positive and Negative Affect Schedule- Calm-Focus
timeFrame: Collected for the second and third iterations of the study at the beginning and and at the end of each mindfulness lesson. The lessons lasted between 10 to 15 minutes.
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston
state: Texas
city: Houston
country: United States
facility: Gulden Esat
state: Texas
Study officials:
affiliation: University of Houston
name: Gulden H Esat, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Houston
name: Bradley H Smith
role: STUDY_CHAIR
References: