Well-beingMSWNCT05397249
The Impact of Mindfulness and Spirituality on Student Well-being
A study testing Mindfulness Training in people with Well-being and Stress, run by University of Houston at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-being, Stress, Anxiety
- What is being tested?
- Mindfulness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Oct 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Houston
Houston, Texas, 77204
Gulden Esat
Houston, Texas, 77479
About this study
Official title: The Impact of Mindfulness and Spirituality on Student Well-being-Efficacy Study
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:
Read more
- 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).
Read the 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.
- Conditions
- Well-being, Stress, Anxiety, Depression
- Being tested
- Mindfulness Training
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TrainingBehavioural
Also called Mindfulness only or Mindfulness with Spirituality
The participants are given strategies of mindfulness, asked to complete worksheets and participate in meditations.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness only training | Experimental | Face to face twice weekly 10 minutes training of Mindfulness only training. Receives: Behavioral: Mindfulness Training |
| Mindfulness with spirituality | Experimental | Face to face twice weekly 10 minutes training of Mindfulness only training plus the Spirituality components. Receives: Behavioral: Mindfulness Training |
| Low dose Mindfulness only | Experimental | Face to face once weekly 10 minutes training of Mindfulness only training. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)?
Measured: 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
Five Facet Mindfulness Questionnaire is a self-report measure that uses a 5 point Likert scale to represent the opinion of the participants about the presented statements in terms of its intensity . "When I'm walking, I deliberately notice the sensations of my body moving." is an example item that participants mark how true it is for them (never or always true). Highest score represents a higher mindfulness quality. Possible highest and lowest scores are 195 and 39.
Measured: 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
The Intrinsic Spirituality Scale is a self-report measure using a degree of agreement scale with 10 Likert points. The items are stated to prompt the participants to choose their level of spirituality. The following is an example item: In terms of the questions I have about life, my spirituality answers no questions ( a score of 0), or all of my questions ( a score of 10). The possible highest and lowest scores are 60 and 0, the highest score indicating a higher spirituality level.
Measured: 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
The measure assesses positive and negative emotions in children and adults. The measure includes 10 items consisting of single words indicating positive and negative affect (e.g. sad, happy, scared, cheerful). The scale had two more items measuring "calm" and "focus" which are conceptualized to represent a mindfulness state. Participants are asked to rate how often they have felt this way during the past week using a 5-point scale with responses: never, a little, moderately, quite a bit, and extremely.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start20 Oct 2018
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-beingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulden Esat, University of Houston
- Investigators
- Gulden H Esat, PhD, Principal investigator, University of HoustonBradley H Smith, Study chair, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397249
- Sponsor's protocol ID
- STUDY00001119
- Acronym
- MSW
- Status last verified
- May 2022
- First submitted
- 11 Nov 2019
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data of self-report data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Mindfulness and Spirituality on Student Well-being-Efficacy Study
- ClinicalTrials.gov ID
- NCT05397249
- Acronym / sponsor ID
- MSW / STUDY00001119
- Conditions
- Well-being, Stress, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 5
- 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).
| Arm | Type | Receives |
|---|---|---|
| Mindfulness only training | Experimental | Behavioral: Mindfulness TrainingFace to face twice weekly 10 minutes training of Mindfulness only training. |
| Mindfulness with spirituality | Experimental | Behavioral: Mindfulness TrainingFace to face twice weekly 10 minutes training of Mindfulness only training plus the Spirituality components. |
| Low dose Mindfulness only | Experimental | Behavioral: Mindfulness TrainingFace to face once weekly 10 minutes training of Mindfulness only training. |
| Low dose Mindfulness with Spirituality | Experimental | Behavioral: Mindfulness TrainingFace to face once weekly 10 minutes training of Mindfulness only training plus the Spirituality components. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness TrainingAlso: Mindfulness only or Mindfulness with SpiritualityThe participants are given strategies of mindfulness, asked to complete worksheets and participate in meditations. | Behavioural | Low dose Mindfulness only, Low dose Mindfulness with Spirituality, Mindfulness only training, Mindfulness with spirituality |
Primary outcome
Change in GPA
Time frame: 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)
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.
Change in reported well-being score measured by Pemberton Happiness Index
Time frame: 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.
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
Change in depression, anxiety, stress symptoms measured by Depression Anxiety Stress Scale
Time frame: 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.
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.
salivary cortisol levels measured by Enzyme Immunoassay Technique
Time frame: At the end of semester (November 2018) collected within a week period.
Saliva was collected from the two intervention groups and sent to the laboratory for analysis of the cortisol level found.
time spent in deep, light, and REM sleep measured by activity tracker
Time frame: At the end of semester (November 2018) collected within a week period.
Sleep quality was tracked with activity trackers from the two intervention groups. Students wore a Fitbit device for three days.
Change in sleep quality measured by Pittsburgh Sleep Quality Index
Time frame: 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.
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.
Change in Community Involvement
Time frame: 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.
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)?
3 secondary outcomes
Change in reported mindfulness score measured by Five Facet Mindfulness Questionnaire
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: Yes. Raw data of self-report data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulden H Esat, PhD principal investigator
University of Houston
Bradley H Smith study chair
University of Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training in people with Well-being and Stress, run by University of Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GPA (time frame: 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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.