The Impact of Mindfulness and Spirituality on Student Well-being

NCT05397249 | Completed

• 1 other identifier: STUDY00001119
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 2

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).

Conditions

Well-being; Stress; Anxiety; Depression

Outcome Measures

Primary Outcomes (7)

• Change in GPA

  Unofficial, and official GPA records collected through permission granted by the participants. UH uses a 4 point GPA scale, higher score representing better academic achievement. The highest and lowest scores are 4 and 0.

  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)

• Change in reported well-being score measured by Pemberton Happiness Index

  Pemberton Happiness Index(PHI) is a self-report measure that measures the degree of agreement to the 11 statements such as "I am very satisfied with my life". A 10-point Likert scale is used, the high score representing better well-being. Also, it has another section that asks for 10 positive and negative events that happened yesterday through a Yes/No checklist. This leads to another score highest 10, lowest 0, which is added to the total score of the previous 11 items. The highest and lowest scores are 120 and 0. PHI yields four types of well-being scores: General, hedonic, eudaimonic, social

  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.

• Change in depression, anxiety, stress symptoms measured by Depression Anxiety Stress Scale

  Depression Anxiety Stress Scale (DASS) is a self-report measure that asks the participants about the symptoms of depression, anxiety, and stress as they apply to them in the past week. It uses a 4 point Likert scale, the highest score representing more intense experience of symptoms. The highest and lowest scores are 63 and 0.

  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.

• salivary cortisol levels measured by Enzyme Immunoassay Technique

  Saliva was collected from the two intervention groups and sent to the laboratory for analysis of the cortisol level found.

  At the end of semester (November 2018) collected within a week period.

• time spent in deep, light, and REM sleep measured by activity tracker

  Sleep quality was tracked with activity trackers from the two intervention groups. Students wore a Fitbit device for three days.

  At the end of semester (November 2018) collected within a week period.

• Change in sleep quality measured by Pittsburgh Sleep Quality Index

  PSQI- Pittsburgh Sleep Quality Index is a self-report measure that uses a 4 point Likert scale of frequency that represents the problems encountered related to the quality of sleep (Cannot get to sleep within 30 minutes). The higher frequency would yield to a lower sleep quality index score. The highest and lowest scores are 57 and 0.

  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.

• Change in Community Involvement

  Self-report of community involvement through a Yes/No response to the following question: Are you involved in any community service (church, non-profit organization, or individual)?

  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 (3)

• Change in reported mindfulness score measured by Five Facet Mindfulness Questionnaire

  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.

• Change in reported spirituality measured by Intrinsic Spirituality Scale

  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.

• Change in reported affect measured by Positive and Negative Affect Schedule- Calm-Focus

  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.

Study Arms (5)

Mindfulness only training

EXPERIMENTAL

Face to face twice weekly 10 minutes training of Mindfulness only training.

Behavioral: Mindfulness Training

Mindfulness with spirituality

EXPERIMENTAL

Face to face twice weekly 10 minutes training of Mindfulness only training plus the Spirituality components.

Behavioral: Mindfulness Training

Low dose Mindfulness only

EXPERIMENTAL

Face to face once weekly 10 minutes training of Mindfulness only training.

Behavioral: Mindfulness Training

Low dose Mindfulness with Spirituality

EXPERIMENTAL

Face to face once weekly 10 minutes training of Mindfulness only training plus the Spirituality components.

Behavioral: Mindfulness Training

No treatment

NO INTERVENTION

No intervention is being delivered, however, participants are led to believe that they are receiving some degree of a mindfulness training embedded in their regular course curriculum.

Interventions

Mindfulness Training BEHAVIORAL

The participants are given strategies of mindfulness, asked to complete worksheets and participate in meditations.

Also known as: Mindfulness only or Mindfulness with Spirituality

Low dose Mindfulness only; Low dose Mindfulness with Spirituality; Mindfulness only training; Mindfulness with spirituality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Houston: lead

Study Sites (2)

University of Houston

Houston, Texas, 77204, United States

Location

Gulden Esat

Houston, Texas, 77479, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Mindfulness; Spiritual Therapies

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Complementary Therapies; Therapeutics

Study Officials

• Gulden H Esat, PhD

  University of Houston

  PRINCIPAL INVESTIGATOR

• Bradley H Smith

  University of Houston

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blind to their conditions.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student

Model Details: 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).

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: May 31, 2022
• Study Start: October 20, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: August 2020
• Access Criteria: Researchers need to contact the PI to request the data.

Locations

US (2)